Seminars

A new seminar cycle starts in September. 

You can read details of the seminars if you click on each as well as you can find a concluding page under "Calendar".

Seminars can be booked individiually as well. If you wish to register individually to selected seminars you can find Registration links in each seminar description. If you like to apply to the Certificate programme, please go to applicaton.

You can find the fees for the seminars here.

Seminar 1: European pharmaceutical regulatory environment

Date

Course 2014/2015:
09-12 (13) September 2014*

Course 2015/2017:
15-18 (19) September 2015*

European pharmaceutical regulatory environment

Content

  • The European Pharmaceutical Legislation
  • The regulatory institutions and other stakeholders
  • Interaction of international regulatory agencies
  • General requirements for the Common Technical Document (CTD), the Marketing Authorisation Dossier - Modules 1 and SmPC, Module 2, Risk Management Plan
  • Special legal provisions for biopharmaceuticals
  • Orphan Drug Designation - provisions and procedures
  • SME - provisions and procedures
  • Principles of registration and certification of medical devices and device/drug combinations

The subject area regulatory affairs ensures that the quality, safety and efficacy of the medicinal product is in line with legal requirements for the purpose of marketing safe and efficacious medicinal products solely in the interests of public health. Regulatory affairs is primarily a specialty of the pharmaceutical industry. The function encompasses all strategic, operational and administrative activities required to obtain official authorisation for Clinical Trials, marketing and distributing of medicinal products, post-marketing changes and obligations and manufacture and the activities related to pharmacovigilance. Seminar 1 provides the basis for all activities of a regulatory affairs professional since it imparts detailed knowledge on the pharmaceutical legislation, the regulatory institutions and stakeholders and their interaction and on the Modules 1 and 2 of the marketing authorisation dossier. Modules 3, 4 and 5 of the marketing authorisation dossier are dealt with in Seminar 4 of this course, specifically describing what is relevant for biopharmaceuticals. This seminar furthermore deals with the particulars of small and medium size enterprises and all regulations related to biopharmaceuticals. It also provides the legal details on orphan drug regulations and on the role and activities of the ICH process.

Learning Objectives

  • Understand the legal basis of authorisation of medicinal products and registration of medical devices and drug/device combinations
  • Provides you with a clear understanding of the EU regulatory system and its stake holders
  • Understand the structure of the EMA and its role
  • Understand the special legal requirements for biopharmaceuticals
  • Understand the principle of the orphan drug designation
  • Understand the incentives dedicated to SMEs and the process to obtain a SME status
  • Provides you with hands-on knowledge on the Common Technical Document, Modules 1and 2

Agenda

Flyer 2015

Agenda 2015

ALL SEMINAR 1 RECORDED PRESENTATIONS (WEBINARS)

Day 1: Tuesday, 15 September 2015

09.15 - 10.15 Welcome and introduction to the whole MSc EUCRAF course on biotech-related regulatory affairs (Gabriele Dallmann, EUCRAF)


10.15 - 11.00 Introduction into the European regulatory system (Geneviève Michaux, Hunton & Williams) RECORDED PRESENTATION

  • How are medicines and devices regulated and why? 
  • What is regulatory affairs?

11.00 -11.30 Coffee break

11.30 - 13.00 The European Pharmaceutical Legislation (Geneviève Michaux, Hunton & Williams) RECORDED PRESENTATION

Essential terms and provisions of the framework defining the marketing of pharmaceutical medicinal products in the EU/EEA

  • The Common Market in the EU/EEA
  • Approval and distribution of medicinal products in the EU
  • Regulations and directives determining the pharmaceutical legislation applicable to the EU/EEA and national pharmaceutical law of the EU member states
  • Notice to applicants
  • Obligations of the marketing authorisation holder
  • Global Marketing Authorisation
  • Data protection and patents
  • Types and procedures of referrals

13.00 - 14.00 Lunch

14.00 - 15.00 Continued

15.00 - 16.00 The regulatory framework for drug/device combination products (Marielle Fournier, Voisin Consulting)

  • The EU regulatory framework for drug/device combination products
  • The specific case of combined ATMP
  • The US regulatory framework for drug/device combination products
  • The key challenges raised by drug/device combination products

16.00 - 16.30 Coffee break

16.30 - 18.30 continued

18.30 End of Day 1

19.00 Get-together with food and wine

Day 2: Wednesday, 16 September 2015

09.15 - 11.15 Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role (Ilham Benassou/ Genevieve Le Visage /Silvia Pfaff, Novartis) RECORDED PRESENTATION

  • Role of the Parliament, Council, EU Commission, DG SANCO
  • Working effectively with the EMA

o Legal basis, role, structure and procedures

o Executive Director

o Management Board

o Secretariat: EMA’s support of the authorisation process of medicinal products

o Involvement of external experts

o QRD product information, invented name requests

o Transparency, communication and publications

o European Public Assessment Report (EPAR)

o Annual Report

  • EMA Scientific Committees, their interaction and their working parties

o CHMP, PRAC, COMP, PDCO, CAT

o Expert committees SAG

  • Involvement of patient organisations
  • The national agencies of the EU/EEA member states
  • The HoA network
  • The Industry trade associations
  • Involvement of patient organisations

11.15 - 11.45 Coffee break

11.45 - 13.45 Continued

13.45 - 14.45 Lunch

14.45 - 16.15 Why are biopharmaceuticals special? What legal particulars for biopharmaceuticals do we have? (Gabriele Dallmann, EUCRAF)

  • Advanced therapies
  • Emerging therapies and technologies
  • Biosimilars
  • Plasma and Vaccine Antigen Master Files
  • Genetically Modified Organism (GMO)
  • Batch release
  • Small and Medium Size Enterprises (SME)

16.15 - 16.45 Coffee break

16.15 - 18.15 continued

18.15 End of Day 2

Day 3: Thursday, 17 September 2015

The Common Technical Dossier (CTD)

09.15 - 10.30 Format and content of the marketing authorisation application: The Common Technical Dossier (CTD) (Lidia Cánovas and Dominique Monferrer, Asphalion, S.L.) RECORDED PRESENTATION

  • General aspects of the harmonised CTD
  • eCTD

Module 1 of the CTD: General information RECORDED PRESENTATION

  • Application form
  • Application numbering
  • Multiple applications: co-marketing and co-promotio
  • Strengths
  • Fees and reduced fees
  • Proposals (Mock-ups) for packaging, labelling and package inserts
  • Specimens
  • INN
  • ATC codes
  • Environmental Risk Assessment (ERA)

Labelling, Package Leaflet and Summary of Product Characteristics (SmPC) RECORDED PRESENTATION

  • Readability test, Braille, Blue Box

10.30 - 11.00 Coffee break

11.00 - 13.00 continued

13.00 - 14.00 Lunch

14.00 - 16.00 Module 2 of the CTD (Lidia Cánovas and Dominique Monferrer, Asphalion, S.L.) RECORDED PRESENTATION

Table of Contents (Module 2 – 5)

  • Module 2.3 Quality Overall Summary
  • Module 2.4 Nonclinical Overview
  • Module 2.5 Clinical Overview
  • Module 2.6 Nonclinical Summary
  • Module 2.7 Clinical Summary

Risk Management Plan (RMP)

16.00 - 16.30 Coffee break

16.30 - 18.00 continued

18.00 End of Day 3

Day 4: Friday, 18 September 2015

09.15 - 10.45 International collaboration of agencies (Gabriele Dallmann, EUCRAF)

  • ICH process: collaboration of the three regions EU, US and Japan
  • Collaboration with FDA
  • Collaboration with other agencies: China, India, Brazil

10.45 - 11.15 Coffee break

11.15 - 12.45 Orphan Medicinal Products in the EU/EEA (Rembert Elbers, formerly BfArM) RECORDED PRESENTATION

  • Legal basis and provisions
  • Orphan designation
  • Orphan status
  • Market exclusivity and further incentives
  • Annual report
  • Register
  • Marketing authorisation procedure
  • Strategy

12.45 - 13.45 Lunch

13.45 - 15.30 continued

15.30 - 16.00 Coffee break

16.00 - 17.00 Small and Medium Size Enterprises (SME) (Gabriele Dallmann, EUCRAF)

  • The particular conditions applicable to Small and Medium Size Enterprises (SME) and the SME office of the EMA
  • SME Regulation and Incentives
  • Type of companies assigned SME status
  • What does the SME Office deliver
  • Scientific advice

17.00 End of Seminar 1

For Full Course students:

Day 5: Saturday, 19 September 2015

09.15 - 11.15 Questions and answers (Gabriele Dallmann, EUCRAF)

11.15 - 12.15 Working Lunch

12.15 - 14.00 Written Exam

14.00 End of Seminar 1 for Full Course students

Dominique Monferrer

Speaker

Rembert Elbers

Federal Institute for Drugs and Medical Devices

Rembert

Prof. Dr. Rembert Elbers is currently Head of BfArM Unit "Orphan Drugs and Rare Diseases."

He studied chemistry and medicine in Hannover and Munich and gains over 41 years of experience. Initially, he worked at the Institute for Physical Biochemistry, LMU Munich, investigating the intracellular compartimentation of energy metabolism. Later, he moved to the Walther Straub Institute for Pharmacology of the LMU Munich investigating molecular mechanisms for the toxicity of amino- and amidophenol derivatives. After joining the BfArM, he worked 1987 - 2000 as a head of unit in charge of scientific co-ordination of NCE drug assessment and European and International matters relating to drug regulatory affairs. From 2000 - 2012 he headed the BfArM Oncology, Haematology und Immunology unit. Since 2000 he is also the German member of the European Committee on Orphan Medicinal Products (COMP) and tasks related to this position are now his main duties at the BfArM.

Topic lectured:

Topics lectured

Seminar 1:

  • Orphan Medicinal Products in the EU/EEA

Marielle Fournier

Voisin Consulting

Marielle

As Director, Marielle has several responsibilities within the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & medicinal products, and especially combination products (i.e. drug/device) and borderline products. She closely follows the evolution of new regulations in Europe.

Marielle also specializes in Quality regulations, such as ISO 9001 / ISO 13485 and EU GMP regulations, and has good knowledge on QSR (21 CFR part 820). She assists in the identification, development and implementation of Quality Systems appropriate to the need, complexity and size of an organization.

Marielle has also important knowledge in European medical devices vigilance (including FSCA and FSN), as well as pharmacovigilance management.

Prior to joining Voisin Consulting, Marielle was Regulatory Affairs Director and Responsible Pharmacist for the La Rochelle site of Carl Zeiss Meditec - Surgical Ophthalmic Business Unit, manufacturing and marketing ophthalmic devices, including implantable, and sterile medicinal products worldwide. She also supervised the Quality Assurance department of this company for several years. Marielle previously worked for Columbia Laboratories, American development company as Regulatory Affairs Officer for hormonal medicinal products and was fully involved in development, sub-contract manufacture and controls of products.

Marielle earned her Pharm.D. degree from the Universities of Pharmacy of Paris XI (Chatenay Malabry) and Clermont Ferrand, France, followed by a post-graduate diploma in Health Care Laws at the Law University of Paris XI (Sceaux).

Topic lectured:

Seminar 1:

  • The regulatory framework for drug/device combination products

Geneviève Michaux

Hunton & Williams

Geneviève

Geneviève is a Belgian and French qualified attorney who focuses on issues surrounding the regulation of drugs, biologicals, medical devices, cosmetics and food in Europe, both at the Union and national level.
Geneviève specialises in European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labelling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Paediatrics Regulation. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
Geneviève is recognized as a leading regulatory lawyer in legal directories and by many organizations. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Topic lectured:

Seminar 5:

  • PIP-related legal aspects

Seminar 1:

  • Introduction into the European regulatory system
  • The European Pharmaceutical Legislation

3rd Annual Biopharmaceuticals Meeting:

  • Session 2: Biosimilar monoclonal antibodies in the EU and the US and Session 3: Drug-diagnostic companion development panel discussion

4th Annual Biopharmaceuticals Meeting:

  • Is the legal pathway ready to regulate drug-diagnostic companion developments?

5th Annual Biopharmaceuticals Meeting:

  • Protection of Biological Medicinal Products – Latest Developments

Silvia Pfaff

Novartis Pharma AG

Silvia

Dr. Silvia Pfaff is Global Head Regulatory Excellence in Drug Regulatory Affairs at Novartis in Basle, Switzerland.

She joined Novartis in July 2007 as EU Regional Head for the Business Franchise Immunology and Infectious Diseases and then took on global responsibility as Global Therapeutic Area Lead for Immunology and Bone.

Prior to joining Novartis she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany.

She has got more than 20 years of regulatory experience in positions with increasing responsibility at Sanofi, Boehringer Mannheim, Knoll, Abbott and Novartis with a focus on biologics over the past 15 years.

She has a proven track record of successful submissions of global products in Europe, the US and Japan and achieving approvals with highly competitive labels.

Dr. Pfaff trained as pharmacist at the University of Heidelberg and earned her Ph.D from the Technical University in Munich.

Topic lectured:

Seminar 1:

  • Regulatory Institutions and other Stakeholders of the European System of Pharmaceuticals, their functions and role

Seminar 9:

  • The regulatory affairs´professional

Coaching Event: Agency meetings

  • Pre-submission meetings

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Lidia Cánovas

Asphalion, S.L.

Lidia

Lidia Cánovas has a degree in Pharmacy from the University of Barcelona and is currently the General Manager - Commercial of Asphalion, S.L., consultancy company to which she associated in 2003.

Her main activities focus on consulting and strategic direction of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in scientific advice, Paediatric Plans, Orphan Drug Designations, Development Plans, Centralized procedures, decentralized and mutual recognition in permanent contact with the regulatory authorities. She also has extensive regulatory experience in innovative, biological, biotech and advanced therapy.

She previously held positions in the pharmaceutical industry as Director of Regulatory Affairs, Vice-Director of R&D and Technical Director (Qualified Person).

Topic lectured:

Seminar 1:

  • Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
  • Module 1 of the CTD: General information
  • Labeling, Package Leaflet and Summary of Product Characteristics (SmPC)

Geneviève Le Visage

Novartis Pharma AG

Dr Geneviève Le Visage is currently heading the EU Regulatory Intelligence & Policy group at Novartis Pharma AG in Basel. Prior to this, she worked for ten years at the European Medicines Agency in London, mainly in the Medical Information sector, where she set up the processes for the publication of public-friendly documents, such as question-and-answer documents designed to explain the rationale for the Agency’s decision on new medicines approvals or on safety reviews. This included defining the standards for the documents, as well as training and managing the medical writing team. She also coordinated all EMA’s activities regarding European Public Assessment Reports (standard operating procedures, monitoring activities, support to internal and external users of EPARs, development of the product and EPAR pages of the EMA website). Prior to joining the EMA, she worked for GlaxoSmithKline in West London in the field of prescribing information.

Dr Le Visage is a pharmacist, having graduated from Nantes University (France) and also holds a masters in Science Communication from Imperial College, London (UK).

Topic lectured:

Seminar 1:

  • Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role

Dominique Monferrer

Asphalion S.L.

Dominique

Dr. Dominique Monferrer holds a degree in Human Biology and a PhD in X-ray Macromolecular Crystallography. She worked for several years as a researcher at molecular laboratory institutions and synchrotrons in Spain and Germany before joining Asphalion as regulatory affairs consultant.

As regulatory affairs manager, her main areas of expertise include providing scientific assessment in development of chemical drugs and biologics (including biosimilars and cell-therapy medicinal products), carrying out and overseeing CMC and medical writing of regulatory documentation (e.g. IMPDs, scientific advice briefing packages, registration dossiers, etc.), as well as conducting viability analyses and designing tailored roadpmaps for innovative medical devices and in-vitro diagnostics.

Topic lectured:

Seminar 1:

  • Format and Content of the MAA Dossier: CTD and eCTD
  • Module 2 of the CTD

Ilham Benassou

Novartis Pharma AG

Ilham

Ilham Benassou is Sub-Region Head in Drug Regulatory Affairs within the Region Europe & Greater China at Novartis in Basel, Switzerland.

She joined Novartis in 2006 and worked as EU RA manager and then as Global RA Director in several therapeutic areas including anti-infective, transplantation and Women & Health products. She has track record of successful submissions and regulatory experience on products spanning from phase I to Phase IV. In her current role, she is providing regulatory leadership for more than 20 countries across the European continent including a role as Regulatory Lead for the IMI SAFE-T consortium for the qualification of clinical safety biomarkers.

Prior to joining Novartis, Ilham Benassou was intern research scientist at the PASTEUR Institute in Paris where she graduated with a Bachelor Degree in biochemistry. She then trained as biotechnology engineer from University of Sciences in Rouen. She completed her education at the University of Pharmacy in Paris XI with a Master Degree in biotechnology and international regulatory affairs.

Topic lectured:

Seminar 1:

  • Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role

Venue & Hotel

Venue and Hotel 2017

Munich, Germany.

Hotel details to be confirmed in due time.

Seminar 2: Regulatory Procedures for clinical trial applications, marketing authorizations, variations in the EU, USA, Japan and China

Date

Course 2014/2015:
28-31 October (01 Nov) 2014*

Course 2015/2017:
08-11 (12) December 2015*

Content

  • The European centralized procedure at the EMA
  • MRP and DCP
  • CTA in Europe – process, VHP, particulars for biopharmaceuticals
  • Variations - changes to the CTD, procedures, data particulars for biopharmaceuticals
  • Changes to the SmPC
  • Approval in other regions - process and essentials of the relevant agencies

Seminar 2 provides in-depth knowledge on the procedures for marketing authorization applications, clinical trial authorisations and variations in the EU, USA, Japan and China. These regions are the most important markets for pharmaceutical products and the appropriate agencies such as the European national agencies, the EMA, the FDA and the Japanese MHLW have major influence on the regulatory strategy in pharmaceutical companies used to develop and submit new medicines. In order to authorise products in these markets successfully companies need to act according to the requirements and procedures of the different regions since they are not harmonised despite increasing efforts. For the EU the centralised procedure and the national mutual recognition and decentralised procedures are described in detail. Furthermore the documentation and steps required to obtain and maintain authorisations for clinical trials are discussed. During the life cycle of products their marketing authorization dossier is changed and the changes are subject to regulatory processes. For biopharmaceuticals these variations are frequently demanding in terms of data and dossier requirements. The seminar focuses in detail on product life cycle activities related to Europe but also provides an overview on the principles to be followed in other regions. 

Learning Objectives

  • Get in-depth knowledge on the European DCP, MRP and centralized procedures for Marketing Authorisation Applications (MAA)
  • Understand the main responsibilities of the European Medicines Agency (EMA) and the details of the centralized procedure
  • Understand the specific requirements of the authorization, clinical trial and post-authorisation procedures in the USA, Japan and China
  • Understand and select the most appropriate registration procedure
  • Manage the particulars of the nationally managed Clinical Trial Applications (CTA) successfully and understand the current Voluntary Harmonisation Procedure and future Procedure for CTAs
  • Delivers the details on the different types of variations valid for biopharmaceuticals
  • Manage to install an effective life cycle system to prepare adequate documentations effectively and the procedures with time-lines successfully
  • Identify which documentation and data are required for each type of variation

Agenda

  • See FULL DETAILED AGENDA HERE

ALL SEMINAR 2 RECORDED PRESENTATIONS (WEBINARS)

Regulatory procedures for clinical trial applications, marketing authorizations and variations in the EU, USA, Japan and China 

  • European centralized procedure at EMA
  • MRP and DCP
  • CTA in Europe – Process, VHP, particulars for biopharmaceuticals
  • Variations - changes to the CTD, procedures, data particulars for biopharmaceuticals Changes to the SmPC
  • Approval in other regions - process and essentials of the relevant agencies 

08 - 11 (12) December 2015
Hotel Novotel München City
Munich, Germany

Course Leaders:
Connie van Oers, Xendo
Gabriele Dallmann, EUCRAF and Biopharma Excellence


Day 1, Tuesday, 8 December 2015 

..................................................................................

09.15 - 09.30
Welcome and introduction
Connie van Oers, Xendo
..................................................................................

09.30 - 10.15
European Centralised Procedure at the EMA

1. Essentials on regulation and procedures

  • Mandatory and optional scope of the centralised procedure Eligibility request
  • Pre-submission activities
  • Conditional marketing authorisation
  • Marketing authorisation under exceptional circumstances Accelerated assessment
  • Appointment and role of the (Co) Rapporteurs and their assessment teams, of the EMEA PTL and of experts of agencies
  • Involvement of working parties and scientific committees other than CHMP

Connie van Oers, Xendo 
..................................................................................

10.15 - 10.45 Coffee break
..................................................................................

10.45 - 11.45
European Centralised Procedure at the EMA

1. Essentials on regulation and procedures

  • Review process

o Procedure
o Validation of the MAA
o Time lines
o Assessment report
o CHMP Peer Review
o Oral explanation
o CHMP Opinion
o Withdrawal
o Re-examination
o Commission decision

  • Life-cycle of European Marketing Authorisations o Actual marketing

o Cessation of placing a product on the market o Suspension
o Revocation
o Withdrawal
o “Renewal”
o Sunset clause
o Annual re-assessment
o Time lines, procedures, documents, exemptions

Connie van Oers, Xendo 
..................................................................................

11.45 - 12.45 Lunch 
..................................................................................

12.45 - 13.45 continued
..................................................................................

13.45 - 14.30 
European Centralised Procedure at the EMA 

2. Strategic aspects to be considered in the interaction with the EMA

  • Success factors of the centralized procedure
  • From pre-submission to approval – what is essential to take care of
  • Best practice for the communication with the EMA
  • How to prepare and perform at oral explanations at the CHMP and expert group meetings such as SAG meetings
  • Good behavior practice for EMA meetings
  • Best slide practice for a successful oral explanation

Michael Pfleiderer, PEI
Gabriele Dallmann, EUCRAF and Biopharma Excellence 
..................................................................................

14.30 - 15.00 Coffee break 
..................................................................................

15.00 – 17.00 
The EMA concept of Adaptive Pathways

  • What is the concept
  • What does it mean for regulatory strategy
Gabriele Dallmann, EUCRAF and Biopharma Excellence 
..................................................................................

17.00 End of Day 1
18.30 Get-together with food and wine 


Day 2, Wednesday, 9 December 2015 

..................................................................................

08.30 - 10.30 
USA

  • Legal basis for medicinal products and medical devices
  • Types and procedures of regulatory submissions
  • Role and function of and interaction with the FDA
  • The FDA’s review process
  • The Investigational New Drug Application (IND)
  • The New Drug Application (NDA)
  • The Biological License Application (BLA)
  • Accelerated development options
  • FDA’s approach to the CTD
  • Supplements and post-marketing obligations
  • Regulations for biopharmaceuticals, biosimilars and advanced therapies
  • Orphan drugs 
Benita von Glahn, Boehringer Ingelheim 
..................................................................................

10.30 – 11.00 Coffee break 
..................................................................................

11.00 - 12.30 
The PDUFA process at FDA 
Benita von Glahn, Boehringer Ingelheim 

..................................................................................

12.00 – 13.30 Lunch
..................................................................................

13.30 - 15.30 
Japan
  • Pharmaceutical legislation in Japan
  • Organisation of and interaction with the MHLW
  • Types and procedures of regulatory submissions
  • Pre-submission procedures
  • Relevance of clinical bridging studies
  • KIKO consultation – Clinical Trial Notification (CTN)
  • Regulations for biopharmaceuticals, biosimilars and advanced therapies
  • Orphan Drugs 
Benita von Glahn, Boehringer Ingelheim 
..................................................................................
15:30 – 16:00 Lunch
..................................................................................

16:00 - 18:00
The regulatory system in China 
  • Pharmaceutical legislation
  • Organisation of the S-FDA
  • Types and procedures of regulatory submissions
  • Pre-submission procedures
  • Clinical Trials
  • Regulations for biopharmaceuticals, biosimilars and advanced therapies
  • Orphan Drugs 
Susanne Szabo, Novartis 
..................................................................................

18:00 End of Day 2
..................................................................................

For whole course attendees: 
17:30 - 17:45
Introduction to the homework
Connie van Oers, Xendo 


Day 3, Thursday, 10 December 2015 

..................................................................................

08.30 - 10.30 
European National Mutual recognition (MRP) and Decentralised Procedure (DCP) 

  • Network and resources of the agencies: role and activities of the RMS, CMS, CMD(h)
  • Filing, validation, time lines, process management, fees
  • Review process
  • Assessment report
  • CMD(h) and CHMP referrals
  • Referral
Connie van Oers, Xendo 
..................................................................................

10.30 – 11.00 Coffee break 
..................................................................................

11:00 - 13:00
Clinical Trial Application (CTA) in Europe: legal basis and relevant procedure 

  • The Clinical Trials Directive
  • European and national guidelines and publications
  • National authorisation procedures and their particulars
    • Content and format
    • Procedures, timelines, submission to regulatory authorities and ethic committees
    • EUDRACT and EUDRACT tracking number o Notification of amendments
    • Safety reporting requirements
    • Annual Safety Report
    • End of Trial Notification
    • Summary Clinical Trial Report
    • “Grounds for Non---approval”(GNA) letter and appeal procedure
  • Interventional and non---interventional trials
  • Voluntary Harmonisation Procedure
  • The new Regulation on Clinical trials 
Hartmut Krafft, PEI
..................................................................................

13:00 - 14:00 Lunch  
..................................................................................

14:00 - 15:00 continued
..................................................................................

17:00 End of Day 3


Day 4, Friday, 11 December 2015 

..................................................................................

08.30 - 10.30 
Variations-European Regulations and national legal provisions for changes to the CTD 

  • Classifications, documentation
  • Procedures and time lines
  • Contact points
  • Downgrading, pooling and consequential changes
  • Multiple agency submissions
  • Appeals
Kora Doorduyn- van der Stoep, MEB 
..................................................................................

10.30 – 11.00 Coffee break 
..................................................................................

11:00 - 13:00
Changes to the Biotech CTD 

  • Data and documentation requirements
  • Typical changes and their evaluation
  • New approaches and challenges for changes and their handling 
Steffen Gross, PEI
..................................................................................

13:00 - 14:00 Lunch  
..................................................................................

14:00 - 14:30 
Discussion on variations

Kora Doorduyn- van der Stoep
Steffen Gross 

..................................................................................

14:30 - 15:30
Changes to the SmPC / Product Information

  • Post-approval procedures
  • Efficacy and safety (pharmacovigilance)
  • Quality changes
  • SmPC Harmonisation
  • Issues and Challenges
Ruth Rettenmeier, PAREXEL Consulting 
..................................................................................

15:30 - 16:00 Coffee break 
..................................................................................

16:00 - 17:30 continued
..................................................................................

17:30 End of Seminar 2
..................................................................................

For Full Course Students: 

Day 5, Saturday, 12 December 2015 

9:00 - 11:30 
Questions and answers
Gabriele Dallmann, EUCRAF and Biopharma Excellence 

11:30 - 12:15 Lunch

12:15 - 13:15 Written Exam

13.15 End of Seminar 2 for Full Course Students 

..................................................................................

Speaker

Kora Doorduyn - van der Stoep

MEB

Kora

She works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, regulatory, management. Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. She is member of several working parties of CMDh with issues related to (the new) Pharmacovigilance legislation (like RMPs/PSURs) as an area for special attention. She has a very broad experience in coordinating/assessing national and European (MRP/DCP/Centralised procedures) application procedures related to marketing authorisations, variations, renewals, worksharing procedures, CHMP and CMD referrals. She has coordinated/assessed a large number of procedures in the role as CMS/RMS and/or rapporteur. From 2002 -2007 she has been managing both regulatory project leaders and clinical assessors in a Pharmacotherapeutic group. In this position she was also responsible for processing/scheduling all registration procedures within this Pharmaco-therapeutic group. She was also a regular visitor of the MRFG (since the establishment of this group) and she represented The Netherlands in the MRFG from 1 January 1997 until 1 October 1997 during the first Dutch presidency of this group. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

Topic lectured:

Seminar 2:

  • Variations-Europe Regulations and national legal provisions for changes to the CTD

Steffen Gross

Paul-Ehrlich-Institut

Steffen

Dr. Steffen Gross is Head of the Section Monoclonal and Polyclonal Antibodies, Laboratory Head as well as Scientific Assessor at the Paul-Ehrlich-Institut in Langen. After his Ph.D. degree in 1998 he had a postdoctoral position at the Institute of Cellular Signaling in the Netherlands. In 2001 he moved to Frankfurt and worked for several years at the University of Frankfurt as research group leader. Since 2005 he is working for the Paul-Ehrlich-Institut where he is responsible for assessments, batch control, inspections, research, scientific advice and regulatory. He is an expert in the field of cell biology , molecular biology and quality and preclinic of monoclonal antibodies, immunoglobulin and also has experience in the field of Batch release/CAP.

Topic lectured:

Seminar 2:
  • European Regulations and national legal provisions for changes to the CTD
  • Variations to the Biotech CTD
2nd Annual Biopharmaceuticals Meeting:
  • Introducing changes in the manufacture – nowadays common but also easy? The current practice for an assessor
3rd Annual Biopharmaceuticals Meeting:
  • Trends, decisions and new guidelines in the past year – CMC requirements for antibody-drug conjugates, QbD experience, substantial amendments and variations, clonality requirements, batch release and more
4th Annual Biopharmaceuticals Meeting:
  • Does innovation reach authorities: trends in scientific advice and review procedures
5th Annual Biopharmaceuticals Meeting:
  • Current topics discussed related to CMC of biopharmaceuticals
    -QbD – is this reality for Biopharma?
    -Critical findings in variations
    -Requirements for CMC changes of biosimilars

Hartmut Krafft

Paul-Ehrlich-Institut

Hartmut

Dr. Hartmut Krafft gained his master degree and PhD at the German Cancer Research Centre Heidelberg, Department of Cell Biology and Immunology. As Post-Doc he worked at the German Cancer Research Centre and the European Molecular Biology Laboratory in Heidelberg as well as for the Institute of Pathology at the University Hospital in Regensburg. At the Paul-Ehrlich-Institut he was responsible for marketing authorization, batch release and regulatory affairs of immunoglobulins, sera and monoclonal antibodies.

Currently he is working as Head of the section Clinical Trials at the PEI. He is Chair of the Heads of Medicines Agencies (MA) Clinical Trials Facilitation Group (CTFG) and Coordinator of the Voluntary Harmonisation Procedure (VHP).

Topic lectured:

Seminar 2:

  • Clinical Trial Application (CTA) in Europe: legal basis and relevant procedure

4th Annual Biopharmaceuticals Meeting:

  • Clinical trials in the EU: where do we stand with the update of the clinical trial regulations

Michael Pfleiderer

Paul-Ehrlich-Institut

Michael

Michael Pfleiderer, Biopharma Excellence, Principal Consultant
Dr. Michael Pfleiderer joined Biopharma Excellence as of March 1st, 2016. In his role as Principal Consultant he will deal with all scientific, regulatory and strategic aspects related to vaccines. Before joining the Biopharma Excellence team he was working at the Paul-Ehrlich-Institut, German Federal Institute for Sera and Vaccines in Langen as Head of "Section Viral Vaccines" and later on as Head of Section "International Cooperation and Regulatory Services". Furthermore he was the Head of the WHO Collaborative Center for the Evaluation and Standardization of Vaccines established at PEI in August 2014. For EMA he was acting as the Chairman of the Vaccine Working Party, Chairman of the Pandemic Task Force as well as Chairman of the CHMP/BWP Influenza ad hoc Working Group. Before his carreer at PEI, Dr. Pfleiderer was working at Baxter AG in Vienna as Head of Laboratory of recombinant Proteins and afterwards Head of Department of Recombinant Vaccines.

Topic lectured:

Seminar 3:
  • Development and regulation of vaccines
  • Use of Antigen Master File
  • Future regulation of seasonal and pandemic influenza vaccines
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)
5th Annual Biopharmaceuticals Meeting:
  • New treatments for Ebola or other emerging diseases outbreaks – how does the expedited pathway work to make them available to patients?

Ruth Rettenmeier

PAREXEL International GmbH

Ruth

Ruth Rettenmeier, PhD, Senior Consultant, PAREXEL Consulting is Biologist with more than 19 year experience in in late stage product development, regulatory affairs and project management.

She is offering regulatory consulting, providing strategic support and doing project management in complex regulatory applications projects, incl. scientific and regulatory experience in preparation, compilation of documents / CTD sections and submission to authorities.

Her focus is on consulting and preparation of Module 1 and Labelling documents for all kinds of MAAs (authority approval and post approval processes) in all EU countries. She is managing complex Language Service projects (25 EU/EEA languages) within the Linguistic Review Process (EU Centralised Procedure), also consulting on Mock-up and Readability.

Topic lectured:

Seminar 2:

  • Changes to the SmPC

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Connie van Oers

Xendo

Connie

Dr. Connie van Oers  has been educated in Molecular Sciences followed by a PhD in Molecular Biology. She has over 20 years experience in Life Science industry of which about 15 years in Regulatory Affairs. She has a broad experience in management of regulatory submissions of both marketed and innovative medicinal products. She was manager Regulatory Affairs, Quality Assurance and Pharmacovigilance for the Dutch affiliate of a multinational pharmaceutical company. Currently, she is managing consultant of an experienced team of consultant dealing with various aspects of regulatory affairs, including Program Management and ATMPs.

Topic lectured:

Seminar 2:

  • European National Mutual recognition (MRP) and Decentralised procedure (DCP)
  • European Centralised Procedure at the EMA

Benita von Glahn

Boehringer Ingelheim Pharma GmbH & Co. KG Regulatory Affairs Biosimilars

Benita

Pharmacist by training with PhD in pharmaceutical chemistry from University of Heidelberg, Germany. Started in pharmaceutical industry in 1998, in German Drug Regulatory Affairs at Mundipharma, Limburg (Lahn), Germany. In 2002 took a position in Regulatory Affairs Immunology at Abbott. From July 2007 lead the International Regulatory Affairs Team Immunology and was appointed in Jan 2011 as TA Head for Humira within Global Regulatory Strategy. Joined Boehringer Ingelheim in February 2013 as Head of Development Regulatory Affairs, Biosimilars. Master’s degree of Drug Regulatory Affairs from University of Bonn in 2008 and a Special Pharmacist degree for Drug Information in 2007.

Topic lectured:

Seminar 8:

  • Interactions with FDA in the pre-IND process

Seminar 2:

  • Regulatory Affairs in Japan

Susanne Szabo

Novartis Oncology

VP & Head DRA EGM & LATAM

Basel SWITZERLAND

Topic lectured:

Seminar 2:

  • The regulatory system in China

Seminar 3: Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products

Date

Course 2015/2017:
30 March-01 (02) April 2016*

 Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products

Content

  • Essentials of the development of monoclonal antibodies – case study

     o Milestones and typical pitfalls in the development of mAbs

  • Registration of vaccines

     o Overview on the product class
     o Underlying immunology of the mode of action and clinical efficacy of vaccines
     o Current and new adjuvants
     o Manufacture and quality control requirements
     o Special characteristics of the pre-clinical and clinical development of vaccines
     o Pre- and post-authorisation documentation requirements for pandemic vaccines

  • Case study: Approval of HPV vaccines in the EU
  • Overview on ATMPs

     o Regulation and relevant procedures
     o Successfully authorised and failed products
     o Case studies illustrating the particulars of ATMP development and registration

  • Registration of blood products

     o Manufacturing methods and quality control approach
     o Requirements for the selection of the starting material
     o Pre-clinical and clinical data requirements
     o Certification scheme on Plasma Master File (PMF)

Four unique product classes are introduced with respect to their regulation, the essential requirements for their development, their unique characteristics. Blood products stand for classical biologicals as they are manufactured from a biological source, i.e. human plasma. Their use is still required for many life-threatening and chronic diseases despite the progress recombinant technology made. Vaccines are mostly recombinant proteins and an increasing number of newly developed products is available which are all of special importance for the health systems. Both, blood products and vaccines, require special considerations in their manufacture, selection of starting material, testing and characterization and clinical development. The product class of monoclonal antibodies delivers an increasing number of novel medicines. Their development requires understanding of their special issues such as manufacturing technology options, species specificity for non-clinical development, pleiotropy, limitations of dose-finding approaches etc. Advanced therapy medicinal products are also unique as they are based on gene therapy, somatic cell or tissue engineering approaches. For these products the conventional requirements for biopharmaceuticals often do not apply as they are developed and manufactured for individual patients.

The development process of a biopharmaceutical has principle features in common with conventional drugs but is special in various aspects since their protein nature requires specific considerations. The four featured product classes illustrate how the current regulatory system ensures that a holistic approach of interaction between the manufacturing/testing, non-clinical and clinical team is followed during development.

Learning Objectives

  • Get an detailed introduction into the product classes of monoclonal antibodies (mAbs), blood products, vaccines and ATMPs
  • Understand why mAbs, blood products, vaccines and ATMPS require a particular development programme
  • Understand the underlying principle of the Plasma Master File
  • Learn the specific requirements applicable for vaccines
  • Get an insight into a special case of a vaccine presented by a regulatory and a company representative
  • Learn the specific regulation of ATMPs and the practical requirements for development

Agenda

Flyer 2016

Agenda 2016

ALL SEMINAR 3 RECORDED PRESENTATIONS


Day 1 Wednesday, 30.03.2016 

09.00 - 09.15 
Welcome and introduction
Gabriele Dallmann, EUCRAF and Biopharma Excellence

09.30 - 10.30
The product class of blood products: The special nature determines the quality, pre-clinical and clinical requirements // Certification scheme on Plasma Master File (PMF)
Gabriele Dallmann, EUCRAF and Biopharma Excellence 

10.30 - 11.00
Coffee break

11.00 - 12.00
continued
Gabriele Dallmann, EUCRAF and Biopharma Excellence

12.00 - 13.00
Lunch

13.00 - 15.00
Overview on ATMPs: Regulation and relevant procedures // Successfully authorised and failed products
Zaklina Buljovcic, PharmaLex 

15.00 - 15.30
Coffee break

15.30 - 17.30 
Case studies to illustrate the challenges in the development of ATMPs: Quality data // Pre-clinical data // Clinical data
Zaklina Buljovcic, PharmaLex

17.30
End of Day 1

19.00
Get together with food & wine

For Full Course students:
17.30 - 17.45 
Introduction to the homework
Gabriele Dallmann, EUCRAF and Biopharma Excellence 


Day 2 Thursday, 31.03.2016 

08.30 - 10.30
Vaccines: History of vaccine development and currently approved products // Vaccination impact and challenges for new developments // Underlying immunology of the mode of action and clinical efficacy of vaccines // Continuing evolution of vaccine antigens // The role of adjuvants in current and new vaccines // Special characteristics of clinical development of vaccines
Jens Vollmar, GSK

10.30 - 11.00
Coffee break

11.00 - 13.00
continued
Jens Vollmar, GSK

13.00 - 14.00
Lunch

14.00 - 15.30  
The product class of monoclonal antibodies (mAb): Technologies used to express mAb // Principle quality requirements // Outsourcing and partnering // Non-clinical and clinical development
Gabriele Dallmann, EUCRAF and Biopharma Excellence 

15.30 - 16.00
Coffee break

16.00 - 17.00
continued 
Gabriele Dallmann, EUCRAF and Biopharma Excellence 

17.00
End of Day 2


Day 3 Friday, 01.04.2016 

08.30 - 10.30
Registration of vaccines: Manufacture and quality control requirements // Pre-clinical package // Benefit/Risk assessment // Pre- and post-authorisation requirements for pandemic vaccines // Special case: Ebola
Michael Pfleiderer, Paul-Ehrlich-Institut (PEI)

10.30 - 11.00
Coffee break

11.00 - 12.30
continued
Michael Pfleiderer, Paul-Ehrlich-Institut (PEI)

12.30 - 13.30
Lunch

13.30 – 15.30
Cervarix as an example for successful authorisation of a HPV vaccine: Introduction // Regulatory history // Clinical development - primary authorization and life cycle of the clinical indication // Success factors
Michael Pfleiderer, PEI & Jens Vollmar, GSK

15.30 - 16.00
Coffee break

16.00 - 17.30
Continued
Michael Pfleiderer, PEI & Jens Vollmar, GSK

17.30
End of Seminar 3


For Full Course students:

Day 4 Saturday, 02.04.2016 

09.00 - 14.00
Exam Seminar 3: Case study with group work

14.00
End of Seminar 3 for Full Course students

Speaker

Zaklina Buljovcic

PharmaLex GmbH

Zaklina

Zaklina Buljovcic, Pharmalex GmbH, Director Scientific Services, Principal Consultant Innovative Therapies. 

She is a biologist by training and holds a PhD in Natural Sciences. She started her professional career in F&E at a small Biotech Company in Heidelberg, Germany in 2000 and joined PharmaLex in 2004. At PharmaLex she held various positions and established different kind of product groups focusing e.g. on tissue preperations, herbal or veterinary products. Since 2008 she is working at PharmaLex as project manager on various ATMP products supporting mainly SME Biotech Companies. This is including strategic regulatory support, preperation of national and EU Scientific Advices, preperation of IMPDs, as well as dossieres for hospital exemption in Germany and EU Centralized Procedures. She is also one of the leading regulatory experts in Germany for ATMPs, giving regularly lectures on various ATMP-topics and engaging in joint industry / health authority working groups.

Topic lectured:

Seminar 3

  • Overview on ATMPs
  • Case studies to illustrate the challenges in the development of ATMPs

Michael Pfleiderer

Paul-Ehrlich-Institut

Michael

Michael Pfleiderer, Biopharma Excellence, Principal Consultant
Dr. Michael Pfleiderer joined Biopharma Excellence as of March 1st, 2016. In his role as Principal Consultant he will deal with all scientific, regulatory and strategic aspects related to vaccines. Before joining the Biopharma Excellence team he was working at the Paul-Ehrlich-Institut, German Federal Institute for Sera and Vaccines in Langen as Head of "Section Viral Vaccines" and later on as Head of Section "International Cooperation and Regulatory Services". Furthermore he was the Head of the WHO Collaborative Center for the Evaluation and Standardization of Vaccines established at PEI in August 2014. For EMA he was acting as the Chairman of the Vaccine Working Party, Chairman of the Pandemic Task Force as well as Chairman of the CHMP/BWP Influenza ad hoc Working Group. Before his carreer at PEI, Dr. Pfleiderer was working at Baxter AG in Vienna as Head of Laboratory of recombinant Proteins and afterwards Head of Department of Recombinant Vaccines.

Topic lectured:

Seminar 3:
  • Development and regulation of vaccines
  • Use of Antigen Master File
  • Future regulation of seasonal and pandemic influenza vaccines
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)
5th Annual Biopharmaceuticals Meeting:
  • New treatments for Ebola or other emerging diseases outbreaks – how does the expedited pathway work to make them available to patients?

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Jens Vollmar

GSK

Jens

Jens Vollmar studied medicine at the university Erlangen-Nuremberg where he acquired his doctor title at the institute for virology working on herpes viruses. Since 1995 he held positions in clinical research at SmithKline Beecham, GlaxoSmithKline and Amgen with focus on biopharmaceutical products and vaccines.

From 2002 he was medical director of Bavarian Nordic where he set up a clinical development, safety and regulatory affairs department. Amongst others he collaborated closely with US government and US FDA regarding the development of new smallpox and HIV vaccines.

Since 2007 he is head of the medical therapeutic area vaccines, tropical and travel medicine at GSK in Munich Germany. In this position he is in charge of medical affairs and clinical development of the entire GSK vaccine portfolio in Germany.

Topic lectured:

Seminar 3:

  • The industry perspective and experience with the recent pandemic influenza
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)

Venue & Hotel

Venue and Hotel 2016

Novotel München City

Hochstrasse 11, 81669 München, Germany

Tel (+49)89/661070 Fax (+49)89/66107999

E-mail h3280@accor.com

Seminar 4.1: The Module 3 (CMC Dossier) of biopharmaceuticals

Date

Course 2015/2017:
May 31st  - June 3rd 2016

The Module 3 (CMC Dossier) of biopharmaceuticals

Content

The Module 3 (CMC Dossier) of biopharmaceuticals

  •   The Module 3 of the CTD of biopharmaceuticals
  •   CMC data requirements of biopharmaceuticals
  •   Module 3 dossier and data requirements for biopharmaceuticals in the USA and Japan
  •   Relevant EMA and ICH CMC-related guidelines
  •   Special areas to be considered for biopharmaceuticals

o Formulation and stability
o Critical process and quality attributes
o Characterisation and testing of biopharmaceuticals o Comparability
o Virus and TSE safety

  •   CMC data requirement for biosimilars
  •   Typical pitfalls in regulatory submissions 

Biopharmaceuticals are special since they stem from a biological source, or the protein structure is transcribed from genetic information and is expressed by a living cell. They are usually complex and large and the quality is determined by the manufacturing process, where consistency and stability need particular attention. This has implications on the way biopharmaceuticals are developed and regulated and particular guidelines are available which are covered in this seminar. The manufacturing process determines the quality of these products and the requirements for the key quality (CMC) issues are complex accordingly. Issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay are covered in this seminar as well as specific topics such as how changes of the process can impact the quality of these products. In addition to the European requirements on biopharmaceuticals the specific requirements of other global regions are dealt with in detail. Furthermore, the specific requirements for IMPs, investigational medicinal products are covered.

Learning Objectives

  • Understand the key quality (CMC) issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay use and apply them in the regulatory strategy
  • Understand and adapt the implications of the introduction of changes in the manufacturing process on the quality of the product, i.e. apply the comparability concept
  • Allows to conduct and steer the relevant regulatory strategy for CTA and MAA submissions for biopharmaceuticals due to knowing the rules and required data for Module 3
  • Understand the CMC essentials of an IMPD/CTA, CTD and MAA submission
  • Understand the regional differences in the scientific requirements for regulatory submissions for biopharmaceuticals and to utilize this in global submissions

Agenda

Flyer 2016

Agenda 2016

ALL SEMINAR 4.1 RECORDED PRESENTATIONS (WEBINARS)


Day 1, Tuesday, 31 May 2016 

09.15 - 09.30
Welcome and introduction
Beatrix Metzner and Heike Volkmer

09.30 - 10.30
The structure of the Quality Module 3 of the CTD for biopharmaceuticals and the relevant guidelines
This session provides an introduction into Module 3 structure first which is used throughout the seminar as a kind of frame, in which the individual headings of the structure are embedded either as interactive sessions or as presentations.
Heike Volkmer

10.30 - 11.00
Coffee break

11.00 - 11.30 
First interactive session of the dossier and data requirements for the individual sections of the Module 3.

For all interactive sessions, Beatrix Metzner and Heike Volkmer develop with the audience the content related to biopharmaceuticals and will summarise at the end of the session the essentials. 

To start with: General information (3.2.S.1 and 3.2.P.1) 

11.30 - 12.15
Manufacture (3.2.S.2 and 3.2.P.3) (Interactive session)

12.15 - 13.00
Control of Materials (3.2.S.2.3.) (Interactive session)

13.00 - 14.00
Lunch

14.00 - 16.00 
How do ICH Q 8, 9, 10 and 11 determine the Module 3 structure and content: 
Controls of critical steps and intermediates (3.2.S.2.4 and 3.2.P.3.4.) // Process validation (3.2.S.2.5. and 3.2.P.3.5.) // Manufacturing process development (3.2.S.2.6. and 3.2.P.2.)
Beatrix Metzner 

16.00 - 16.30
Coffee break

16.30 - 17.30
Continued

Time for discussion until 18.15

18.30
End of Day 1

19.00 

Get-together with food and wine


Day 2, Wednesday June 1st 2016

09.15 – 11.15 
Characterisation of biopharmaceuticals (3.2.S.3)
Importance of product characterisation // Examples of parameters investigated and their impact on process and product consistency: Heterogeneity and isoforms, Glycosylation, Undesired modifications of molecules, Potency determination, Impurities, 
Heike Volkmer 

11.15 – 11.45
Coffee break

11.45 – 13.00
Control of Drug Substance / Drug Product (3.2.S.4. and 3.2.P.5.) (Interactive session)

13.00 – 14.00
Lunch

14.00 – 15.00 
Continued

15.00 – 15.45 
Virus and TSE-safety of biopharmaceuticals
Overview on the risks of transmission of infectious agents // General principles of ensuring virus and TSE safety //   Principles of virus validation of the manufacturing process capacity to inactivate and remove viruses and TSE //   Requirements for early stage products (IMPs) versus late stage and commercial products (Phase 3 and MAA)
Johannes Blümel, Paul-Ehrlich-Institut 

15.45 – 16.15
Coffee break

16.15 – 18.30 
Continued

18.30
End of Day 2


Day 3, Thursday June 2nd 2016

09.00 – 10.30
Interactive session: Reference Standards (3.2.S.5. and 3.2.P.6.) // Container Closure System (3.2.S.6. and 3.2.P.7.) // Stability (3.2.S.7. and 3.2.P.8.) 

10.30 – 11.00
Coffee break

11.00 – 13.00
Interactive session: Pre- and post-authorization changes // The comparability exercise – what to do and what to present in the dossier when the manufacturing process is changed 

13.00 – 14.00
Lunch

14.00 – 16.00 
Formulation and drug product manufacturing of biopharmaceuticals: Formulation development // Process development // Routes of administration // Special developments to modify proteins and formulations
Astrid Pappenberger, F. Hoffmann-La Roche Ltd. 

16.00 – 16.30
Coffee break

16.30 – 18.30
Consideration for the CMC development and submission requirements for a drug-device combination product
Florian Lengyel, Boehringer Ingelheim

18.30
End of Day 3



Day 4, Friday June 4th 2016

09.00 – 10.30
CMC particulars of biosimilars
Beatrix Metzner

10.30 - 10.45
Coffee break

10.45 - 12.45 
Experience with the CMC review procedure by EMA and FDA of Gazyva, a global dossier with approved design space
Elisabeth Kirchisner, Roche 

12.45 – 13.45
Lunch

13.45 – 14.30  
What is special in other regions on Module 3 requirements?  USA // Japan // Other regions
Beatrix Metzner 

14.30 – 14.45
Coffee Break

14:45 - 16.30
Regulatory CMC concerns and issues from an agency perspective
Michael Pfleiderer, Paul-Ehrlich-Institut 

16.30
End of Seminar 4.1

Speaker

Beatrix Metzner

Boehringer Ingelheim

Beatrix

Dr. Beatrix Metzner studied chemistry at the University of Regensburg and the Albert-Ludwigs-University of Freiburg where she was specialized in biochemistry. Furthermore she was PhD student at the Department of Experimental Dermatology at the University of Freiburg and Post Doctoral research Fellow at the Memorial Sloan-Kettering Cancer Center (Immunology Program) in New York (Research fellowship of the German Research Society).From 2000 she worked at MediGene AG as Senior Scientist, later Manager Operations and Senior CMC Project Manager. In 2005 she started to work at Merck KGaA as Project Manager (CMC - Bio-manufacturing/Protein Supply).In 2007 she moved to Global Regulatory Oncology where she has been working as Director Global Regulatory Oncology since November 2008. Since November 2013 she took over the position as Head of Global Regulatory CMC Strategy Biosimilars at Boehringer Ingelheim.

Topic lectured:

Seminar 4.1:

  • Quality Module 3 of the CTD for recombinant and classical biopharmaceuticals
  • Characterisation, quality control and analytical techniques
  • Essential differences in Module 3 considerations USA
  • Essentials for Module 3 in Japan
  • Changes in process and their implications on the molecule, the comparability exercise

Michael Pfleiderer

Paul-Ehrlich-Institut

Michael

Michael Pfleiderer, Biopharma Excellence, Principal Consultant
Dr. Michael Pfleiderer joined Biopharma Excellence as of March 1st, 2016. In his role as Principal Consultant he will deal with all scientific, regulatory and strategic aspects related to vaccines. Before joining the Biopharma Excellence team he was working at the Paul-Ehrlich-Institut, German Federal Institute for Sera and Vaccines in Langen as Head of "Section Viral Vaccines" and later on as Head of Section "International Cooperation and Regulatory Services". Furthermore he was the Head of the WHO Collaborative Center for the Evaluation and Standardization of Vaccines established at PEI in August 2014. For EMA he was acting as the Chairman of the Vaccine Working Party, Chairman of the Pandemic Task Force as well as Chairman of the CHMP/BWP Influenza ad hoc Working Group. Before his carreer at PEI, Dr. Pfleiderer was working at Baxter AG in Vienna as Head of Laboratory of recombinant Proteins and afterwards Head of Department of Recombinant Vaccines.

Topic lectured:

Seminar 3:
  • Development and regulation of vaccines
  • Use of Antigen Master File
  • Future regulation of seasonal and pandemic influenza vaccines
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)
5th Annual Biopharmaceuticals Meeting:
  • New treatments for Ebola or other emerging diseases outbreaks – how does the expedited pathway work to make them available to patients?

Heike Volkmer

Volkmer & Burt Consulting Team

Heike

Heike has almost 30 years of experience in national and international regulatory affairs, with specialist expertise in the European centralised procedure for biotechnologically-derived medicinal products. During this time, Heike has contributed to the successful approval of several biological and biotechnological products, including one of the first biosimilar medicines. Over the years, Heike has established a large number of personal contacts with representatives of the national EU authorities, the EMEA, CDER, CBER, TGA, and various other international agencies. She is a recognised expert for regulatory strategy and has authored or co-authored a number of CMC Expert Reports (Quality Overall Summaries). Since October 2000, Heike is Managing Partner of the VBC Team, a position she shares with her long-standing colleague, Tony Burt.

Topic lectured:

Seminar 4.1:

  • Characterisation of biopharmaceuticals (3.2.S.3)

Florian Lengyel

Boehringer Ingelheim Pharma GmbH & Co. KG

Florian

Florian Lengyel is a Global DRA CMC Manager Biopharmaceuticals and topic leader for drug/device combination products at Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany. He graduated with degrees in Environmental Biology (B.Sc.) and Applied Environmental Sciences (M.Sc.) from the Queen’s University of Belfast, Northern Ireland and holds a PhD in Animal Physiology from the University of Bayreuth, Germany.
After a short stint as a post-doc he worked at Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany as a Regulatory Affairs Associate and later as Deputy Team Leader Reg. Affairs / Compliance for over 5 1/2 years. He joined Boehringer Ingelheim in April 2012. He has more than 8 1/2 years’ experience in CMC Regulatory Affairs specializing on drug product and delivery devices for bio-pharmaceuticals and small molecules. Florian Lengyel also lecturs at Medicademy, Copenhagen, Denmark.

Topic lectured:

Seminar 4.1:

  • Consideration for the CMC development and submission requirements for a drug-device combination product

Venue & Hotel

Venue and Hotel 2016

Novotel München City

Hochstrasse 11, 81669 München, Germany

Tel (+49)89/661070 Fax (+49)89/66107999

E-mail h3280@accor.com

 

Seminar 4.2: Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements

Date

Course 2014/2015:
03-06 March 2015*

Course 2015/2017:
07. – 09.09.2016

Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements

Content

  • Principles of the non-clinical development
    • What is special in the pre-clinical development of biopharmaceuticals
    • Which investigations are required at which stage of development
    • The non-clinical dossier of biopharmaceuticals (Module 4)
    • What did change after the TeGenero Case
  • Principles of the clinical development
    • The clinical dossier of biopharmaceuticals
    • Development and use of biomarkers and companion diagnostic
    • Key elements of the benefit-risk assessment
    • The clinical dossier of biopharmaceuticals (Module 5)
  • Immunogenicity
  • Development and registration of biosimilars
  • Case studies on a biosimilar mAb and on benefit-risk assessment

Biopharmaceuticals play an important role in the pharmaceutical industry since they deliver an increasing number of candidates for new product developments. They are however special and require certain considerations in their pre-clinical and clinical development. They are pleiotrop and immunogenic and their non-clinical pharmacodynamic and safety characterisation is often hampered by insufficiently relevant animal models. Biosimilars are developed following a special regulation and expanded programme as compared to conventional generics. This all has implications on the way biopharmaceuticals are developed and regulated. The particulars of the non-clinical and clinical requirements of biopharmaceuticals are covered and the specific considerations on the development of biosimilar medicinal products are part of this seminar as well. In this seminar case studies will also be presented on successfully authorized products, such as on a tri-functional monoclonal antibody and on a biosimilar. The seminar also introduces how to perform a benefit-risk assessment at the authorization stage and how to update it during life-cycle of the product.

Learning Objectives

  • Understand the specific challenges in the pre-clinical development of biopharmaceuticals
  • Understand the essential clinical development approach
  • Learn to assess the benefit-risk ratio during the whole life cycle of a product
  • Understand the data requirements specific to biosimilars
  • Learn why immunogenicity is a typical issue for biopharmaceuticals and how it is investigated and handled appropriately
  • Allows to conduct and steer the relevant regulatory strategy for CTA and MAA submissions for biopharmaceuticals due to knowing the rules and required data for Modules 4 and 5 of biopharmaceuticals

Agenda

Flyer 2016

Agenda 2016

ALL SEMINAR 4.2 RECORDED PRESENTATIONS (WEBINARS)

Course Leaders:

Ronald Grobe-Einsler, formerly Bayer, and

Gabriele Dallmann, EUCRAF and Biopharma Excellence

 

Day 1

09.15 - 09.45 Welcome and Introduction (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

09.45 - 10.45 The principle of clinical development of biopharmaceuticals (Gabriele Dallmann, EUCRAF, Biopharma Excellence)

  • Target rationale definition
  • Dose-finding justification
  • Proof of Concept and confirmatory studies
  • Relevant efficacy and safety studies – pivotal trials
  • Principles of the clinical review and decision on the benefit-risk conclusion
  • Module 2 sections 2.5 and 2.7.
  • Presentation of clinical data in Module 5 of the CTD

10.45 - 11.15 Coffee Break

11.15 - 12.45 continued

12.45 - 13.45 Lunch

13.45 - 15.45 Research to early development: a clinical pharmacology perspective (Ronald Grobe-Einsler, formerly Bayer)

  • Future clinical Proof-of-Concept strategies
  • Validity of biomarkers in drug development
  • Why large trials fail - although effects (efficiency) have been seen in small studies

15.45 - 16.15 Coffee Break

16.15 – 17.45 Case study (TBC)

17.45 End of Day 1

Day 2

09.15 - 11.00 Case study for group work: How to define the clinical development programme of a new monoclonal antibody – from Phase I to Phase III towards a positive benefit-risk assessment (Introduction by Roland Grobe-Einsler and Gabriele Dallmann)

11.00 - 11.30 Coffee break

11.30 – 13.00 Immunogenicity (Paul Chamberlain, Biopharma Excellence, bioLOGICA Consulting)

  • What is immunogenicity?
  • How is immunogenicity caused?
  • How is immunogenicity tested ?
  • Risk-based approach

13.00 - 14.00 Lunch

14.00 - 15.00 Case study: Erythropoietin and PRCA (Paul Chamberlain)

15.00 - 15.30 Coffee break

15.30 - 18.00 Regulatory principles of development of biosimilar medicinal products in the various regions (Thomas Kirchlechner, Sandoz Biopharmaceuticals Development)

  • EU
  • FDA
  • WHO

Global development, experience with submissions in different regions

Experience with Sandoz biosimilars

18.15 End of Day 2

19.00 Get-together with food and wine

Day 3

09.15 - 10.45 Current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars (Thomas Kirchlechner, Sandoz Biopharmaceuticals Development)

10.45 - 11.15 Coffee break

11.15 - 13.00 Case Study for group work: Development of a biosimilar monoclonal antibody (Introduction by Thomas Kirchlechner)

13.00 - 14.00 Lunch

14.00 - 15.00 Continued

15.00 - 15.30 Coffee break

15.30 - 17.00 Case study: Molybdenum Cofactor deficiency: Bench to bedside and Beyond (Alex Veldman, Monash University, Melbourne, Australia; now CSL Behring)

17.00 End of Day 3

Day 4

09.15 - 11.00 Principles of non-clinical development

The non-clinical CTD (Jennifer Sims, Integrated Biologix GmbH)

What is special in the non-clinical development of biopharmaceuticals

  • Unique characteristics of biotech products to be considered when designing a preclinical programme
  • Pharmacodynamic studies and disease models considerations for pharmaco- and toxicokinetic studies
  • Immunogenicity in non-clinical models

11.00 – 11.30 Coffee break

11.30 - 13.00 The TeGenero case and its implications for the development of new biopharmaceuticals (Jennifer Sims, Integrated Biologix GmbH)

13.00 - 14.00 Lunch

14.00 End of Seminar 4.2.

For Full Course students:

14.00 - 15.30 Exam: case study. Introduction, group work, presentations

15.30 - 16.00 Coffee break

16.00 - 18.00 continued

18.00 End of Seminar 4.2. for Full Course students

Speaker

Paul Chamberlain

Biopharma Excellence / bioLOGICA Consulting

Paul

He has accumulated substantial industrial experience in the development of biopharmaceutical products. This experience includes a broad scientific background, incorporating the application of analytical and bioanalytical technologies to the quality control of therapeutic proteins. At MDS Pharma Services Paul was responsible for providing expert consulting on strategies for biopharmaceutical development programs as well as leading development teams responsible for the execution of contracted analytical, bioanalytical, non-clinical, clinical and regulatory services. In this role Paul prepared briefing packages to support Pre-IND and other regulatory agency discussions and defined activities associated with pertinent stagegates in the product development cycle – including lead candidate selection, manufacturability assessment and IND-enabling studies. He also served as a member of the Scientific and Regulatory Advisory Boards of different companies and was involved in due diligence assessments of various in/out-licensing opportunities. In order to focus on strategic planning and the preparation of responses to regulatory agency questions Paul formed his own consulting practice, bioLOGICA Consulting, in July 2007. In addition, in October 2007, Paul was appointed to the Advisory Board of NDA Regulatory Science, where he collaborates with former senior European regulators. FDA-facing experience includes involvement in the preparation of IND’s and BLA’s for recombinant proteins, as well as direct interactions up to the level of FDA Advisory Committee meetings to support product registration decisions.

Topic lectured:

Seminar 4.2:

  • Immunogenicity
  • Erythropoeitin

Immunogenicity Integrated - Interactive Workshop:

  • The current regulatory environment for new therapeutic proteins and biosimilars exemplified by cases following a risk-based strategy

3rd Annual Biopharmaceuticals Meeting:

  • Essentials to know in 2013 on immunogenicity of therapeutic proteins. An update on most recent occurrences, regulatory activities and scientific progress

Coaching: Applying risk assessment to the design of an effective comparability protocol

Workshop: Immunogenicity - Understanding the Regulatory Philosophy:

  • How is immunogenicity assessed for different product types, from biosimilars to enzyme/factor replacement therapies?
  • What are the implications of this philosophy for data presentation? Intrinsic immunogenicity & systems biology
  • Product quality
  • Case examples illustrating impact of product type on nature of bioanalytical data package
  • The “Integrated Summary of Immunogenicity” model

Ronald Grobe-Einsler

Consultant, formerly Bayer

Ronald

Dr. Ronald Grobe-Einsler has a PhD in Chemistry and Medicine.

Postdoctoral he worked for several years as Deputy Medical Director at Beecham Wülfing in Neuss.

After three years working for Bayer AG as international Clinical Project Manager for antidementia drugs he became in 1993 Medical Director Germany at Bayer AG, Leverkusen. In 1998 he moved to London where he worked as Medical Director Europe and Overseas. From the year 2000 to 2007 he was Head of the Global Clinical Pharmacology at Bayer AG. Since his retirement in 2007 he is working as Consultant for the pharmaceutical industry.

Topic lectured:

Seminar 4.2:

  • Research to early development: a clinical pharmacology perspective

Thomas Kirchlechner

Sandoz GmbH

Thomas

Thomas Kirchlechner holds a Master's degree in chemistry from the University of Munich and a PhD from Otago University in Dunedin, New Zealand. He has over 14 years experience in the pharmaceutical industry, including finished dosage form production, active ingredient strategic sourcing, and, for the last 11 years, in regulatory affairs specializing in biopharmaceutical and biosimilar products at Sandoz GmbH Kundl, Austria.

Topic lectured:

Seminar 4.2:

  • Regulatory principles of development of biosimilar medicinal products in the various regions 
    - EU
    - FDA
    - WHO
  • Global development, experience with submissions in different regions
  • Experience with Sandoz biosimilars
  • Current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars
  • Biosimilar Case Study

3rd Annual Biopharmaceuticals Meeting:

  • Industry experience with authorisations of biopharmaceuticals in Brazil

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Jennifer Sims

Integrated Biologix GmbH

Jennifer

Jenny has a Bachelor of Science degree and a PhD in Pharmacokinetics and Toxicology. Jenny has 25 years experience in preclinical drug development from both the regulatory (UK MHRA, UK delegate to CHMP Safety Working Party) and industry perspectives, with an emphasis on biotechnology products (monoclonal antibodies, therapeutic proteins, vaccines, gene and cell therapies and xenotransplantation). In addition to experience of preclinical drug development in a large pharma environment (Global Head Biologics Safety and Disposition, Novartis Institutes of BioMedical Research and Director of Safety Assessment for Biopharmaceuticals, AstraZeneca), Jenny also has experience as both Preclinical Director and Head Safety Assessment with several start-up and small biotech companies (Syngenta Biopharma, Cambridge Antibody Technology, MedImmune) and developing relationships with CROs and external partners. Jenny is Past vice Chair of the BioSafe leadership group and was EFPIA topic leader and Rapporteur for ICH S6 revision.

Topic lectured:

Seminar 4.2:
  • The Tegenero case and its implications for the development of new biopharmaceuticals
2nd Annual Biopharmaceuticals Meeting:
  • Current scientific considerations in the preclinical development of biopharmaceuticals in 2012 following the news from the ICH S6 guideline revision process
5th Annual Biopharmaceuticals Meeting:
  • Summary of the NC3R workshop held in June 2014: a future vision for non-clinical protein-based biotherapeutic development

Alex Veldman

CSL Behring

Alex

Alex is a board certified pediatrician, neonatologist and pediatric cardiologist with more than 10 years of experience in managing critically ill newborns and children in large university hospitals and 3 years of experince in the role as Director in Global Clinical R&D at CSL Behring. His clinical expertise in the area of pediatric and neonatal critical care medicine becomes evident in > 50 pubmed listed research papers that received > 700 citations.

In the last three years, Alex focused on the transition of programs form pre-clinical Proof of Concept into first–in-human Phase 1 studies. Alex is familiar with the scientific and regulatory requirements for pre-clinical toxicology, immunogenicity and dose finding. In his current role as leader of a multifunctional clinical development team in a highly matrixed environment he has successfully designed the key strategy of several clinical development plans for new bio-pharmaceuticals from Phase I to Phase III and negotiated a pathway to registration with the major global regulatory bodies (EMA, TGA, MFDS, PMDA and FDA). Alex is familiar with the process of orphan drug registration in various legislations and has experience in developing pediatric investigational plans (PIP) as required for the market authorization for new medicines in the EU.

Alex has successfully partnered an academic drug development program with a US pharmaceutical company (Alexion Pharmaceuticals, Connecticut, USA) and had the lead responsibility for the clinical part of the due diligence in that process. In addition to his role in industry, he is still holding an academic position as Associate Professor in the Faculty of Medicine, Dept. of Pediatrics at Monash University in Melbourne, Australia.

Topic lectured:

Seminar 4.2:

  • Case study: Molybdenum Cofactor deficiency: Bench to bedside and Beyond

Venue & Hotel

Venue and Hotel 2016

Munich, Germany.

Hotel details to be confirmed in due time.

Seminar 5: Specific considerations for the development and authorization of medicinal products for children

Date

Course 2014/2015:
29-30 April (01 May) 2015*

Course 2015/2017:
End of November 2016*

Specific considerations for the development and authorization of medicinal products for children

Content

  • Background of development and content of the Paediatric Regulation No 1901/2006 EC
  • The role of the EMA and of the Paediatric Committee (PDCO)
  • The Paediatric Investigational Plan (PIP) (Scope, legal aspects, considerations for developing and executing the PIP, Preparation of the PIP)
  • Requirements on paediatric drug formulations
  • Juvenile Animal Studies
  • Implications of the EU legislation for the pharmaceutical industry: perspectives, challenges and opportunities
  • Other regions, focus on US

The new legislation on the development and authorization of medicines for use in children aged 0 to 17 years was introduced in the European Union in January 2007. The Paediatric Regulation (Regulation/EC No 1901/2006 as amended) affects the regulatory environment for pharmaceutical companies and agencies enormously since it required many new tasks and responsibilities for the authorities, mainly the EMEA, and remarkable new requirements for the overall development plans of medicinal products for all types of pharmaceutical companies. Seminar 5 is designed to provide comprehensive information on the new European requirements for medicines for children, the legislation, regulatory bodies and procedures and their practical implementation in the daily work of a pharmaceutical company. In addition to the European requirements on the development of medicines in children the regulations of the FDA and of other regions are dealt with in detail.

Learning Objectives

  • Understand the requirements and principles of authorization of medicinal products for use in children
  • Learn the key strategic considerations and their implications on the general strategy of a company followed in their development programme
  • Understand the details of the regulatory procedures to follow and the stake holders involved
  • Understand the issues to be considered in the planning of the paediatric development programme
  • Develop the appropriate regulatory strategy for the Paediatric Investigation Plan (PIP)
  • Prepare a PIP successfully

Agenda

Flyer 2016

Agenda 2016

ALL SEMINAR 5 RECORDED PRESENTATIONS (WEBINARS)

End of November 2016

Munich, Germany

Course Leader:

Avril Mankel, Santen GmbH

Day 1

09.00 - 09.15 Welcome and introduction (Avril Mankel, Santen GmbH)

09.15 - 10.15 EMA and the Paediatric Committee (PDCO) (Daniel Brasseur, former PDCO Chair- CHMP member)

  • Role, function, procedures and decision-making
  • Interactions with other EMA’s committees and working parties

The scope of the Paediatric Investigation Plan (PIP)

  • Waivers (incl. class waivers), deferrals
  • Indications and conditions
  • Regulator’s experience with Articles 7 & 8
  • Opinions and decisions on PIP applications
  • Considerations for obtaining scientific advice

List of paediatric needs and priority list of off-patent medicines

Publication of clinical trial results

Development of regulatory guidelines on considerations of drug development in children

10.15 - 10.45 Coffee Break

10.45 - 12.15 continued (Daniel Brasseur, former PDCO Chair- CHMP member)

12.15 - 13.15 Lunch

13.15 - 15.15 Preparation of the Paediatric Investigation Plan (PIP) (Avril Mankel, Santen GmbH)

  • Format
  • Application - incl. Application for PUMA (Paediatric Use Marketing Authorisation)
  • Regulatory procedure for the PIP assessment by the PDCO
  • EMA Paediatric Team: roles and responsibilities during the assessment vs. PDCO

15.15 - 15.45 Coffee Break

15.45 - 17.30 Considerations for developing and executing the PIP (Ashley Strougo, Astellas Pharma Global Development Europe)

  • Clinical trials (Criteria and decision-making on First in Child studies, EudraCT)
  • PK modelling and extrapolation

Paediatric Networks

17.30 – 18.30 Requirements on paediatric drug formulations (Jörg Breitkreutz, University of Düsseldorf)

18.30 End of Day 1

19.00 Get-together with food and wine

Day 2

09.00 - 11.00 PIP-related legal aspects (Geneviève Michaux, Counsel at Hunton & Williams)

  • Legal aspects related to Article 7 & 8 under the global marketing authorisation concept
  • Compliance checks
  • Rewards for paediatric data
  • National Patent Offices

11.00 - 11.30 Coffee Break

11.30 - 13.00 Juvenile animal studies (David M. Cross, Cross Pharma Consulting Limited, formerly Pfizer Global Research and Development UK)

13.00 - 14.00 Lunch

14.00 - 14.45 The EU Regulation No 1901/2006 on medicinal products for paediatric use – the Paediatric Regulation (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

  • Implementation of the Paediatric Regulation and Commission PIP guideline

14.45 - 15.45 Regulation for medicines in children in other regions with focus on the US (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

15.45 - 16.15 Coffee Break

16.15 - 17.00 Implications of the EU legislation for the pharmaceutical industry: Perspectives, challenges and opportunities (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

17.00 - 18.00 Case illustrating PIP practice with discussion (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

18.00 End of Seminar 5

For Full Course students:

Day 3

09.00 - 10.30 Debriefing & discussion of the homework

10.30 - 11.00 Coffee break

11.00 - 12.00 Written exam

12.00 End of Seminar 5 for Full Course students

Speaker

Daniel Brasseur

former PDCO Chair- CHMP member

Daniel

Daniel Brasseur (born 07.06.51) is bachelor of the European School in Brussels and was graduated as a licensed paediatrician (1981) after studying medicines at the Free University Brussels (ULB). After a 3 years stay in Central Africa and 2 years as a Medical Director in Industry, he moved to the University Children’s Hospital Queen Fabiola (Belgium) and specialised in nutrition.
At the laboratory of Paediatrics and Metabolic Diseases, he built up a unit for Nutrition and Pharmacology. He studied the impact of diet and nutrition on several enzymatic systems and immune reactions. His interest in infantile research led him to chair since 1994 the Ethical Committee of his Institution (up to 2001) and to participate to the evaluation of new and innovative drugs. This naturally brought him to take part in his National Drug Commission as an evaluator and further (1997) as a co-ordinator of the team of medical assessors at the Federal Ministry of Public Health. He continued his activities and moved to the Federal Agency for Medicines and health products ( FAMHP) when this body was created (January 2007).
He joined CPMP in 1997 at the European Medicines Agency (EMA, London) and was elected chair in 2001 up to 2007. He was also the Chair of the CHMP-Paediatric Expert Group and a member of the CHMP-Vaccine Expert Group at the same Agency. Later in 2007 he became chair of the Paediatric Committee (PDCO) at the EMA and was re-elected in 2010. In his academic activities he is an Associate Professor of Paediatrics and a Professor of Nutrition at the Faculty of Medicine (Free University Brussels-ULB) and still works as a part time consultant at the University Children’s Hospital (Brussels).
He is a member of the National Council for Hygiene and of the National Nutrition Council. He was a member of the Scientific Subcommittee on Diet and Allergy of the European Food Safety Agency (EFSA) since 2002-2005. He is a member of several international societies in nutrition and pharmacology.
He is the author or co-author of more than 100 publications and communications in paediatrics, nutrition and infantile pharmacology.

Topic lectured:

Seminar 5

  • EMA and the Paediatric Committee (PDCO)
  • The scope of the Paediatric Investigation Plan (PIP)
  • List of paediatric needs and priority list of off-patent medicines
  • Publication of clinical trial results
  • Development of regulatory guidelines on considerations of drug development in children

Jörg Breitkreutz

Heinrich-Heine-University Düsseldorf

Jörg

Jörg Breitkreutz studied Pharmacy from 1987 to 1991 at the Westphalian Wilhelms-University of Münster, Germany. He finished his PhD in 1996 at the Institute for Pharmaceutical Technology and Biopharmaceutics in Münster under the supervision of Prof. Rüdiger Gröning. From 1996 to 1997 he joined Thiemann Arzneimittel GmbH in Waltrop, Germany, as the Head of Product Coordination. In 1997 he went back to the university in Münster to work on his habilitation thesis (2004) on pediatric drug formulations. In 2004 he became professor for pharmaceutical technology at the Institute of Pharmaceutics and Biopharmaceutics at the Heinrich-Heine-University in Düsseldorf, Germany and today is the director of this institute. Joerg Breitkreutz is member of the European Paediatric Formulation Initiative (EuPFI) and serves as external expert for various regulatory bodies and companies. In 2010 the non-for-profit International Association of Pharmaceutical Technology (APV) elected him for the president. His research focuses on pediatric and geriatric drug formulations, development of orphan drugs and process analytical technologies.

Topic lectured:

Seminar 5

  • Requirements on paediatric drug formulations

Koen Crombez

Merck Sharp & Dohme (Europe), Inc.

Koen

Koen Crombez holds a Master degree in Science (Biology) and a PhD degree in Medical Sciences, both obtained at the University of Leuven (Belgium).
Koen started his career in Regulatory Affairs in 2005 within the European Regulatory Affairs department at Bristol-Myers Squibb, where he coordinated regulatory activities within the Infectious Diseases and Oncology therapeutic areas. Since 2009, Koen is working within the Regulatory Affairs Europe team at Merck Sharp & Dohme as a regulatory liaison, first within the Ophthalmology franchise. Currently, he is mainly responsible for providing regulatory strategic input into programs in the Infectious Diseases franchise (both licensed products and development programs).
Koen has a profound interest in paediatric development and advises the European and Global Regulatory Affairs team at Merck on strategic and procedural issues around EU paediatric development, in the framework of his assignment as EU paediatric subject matter expert.

Topic lectured:

Seminar 5:

  • The EU Regulation No 1901/2006 on medicinal products for paediatric use – the Paediatric Regulation
  • Regulation for medicines in children in other regions with focus on the US
  • Implications of the EU legislation for the pharmaceutical industry: Perspectives, challenges and opportunities
  • Case illustrating PIP practice with discussion

David M. Cross

Cross Pharma Consulting Limited

David M.

David is Founder and Managing Director of Cross Pharma Consulting Ltd which specialises in providing non-clinical scientific and regulatory support to the Biotech and Pharma industry. Formerly, David was a Regulatory Strategy Lead for non-clinical drug safety at Pfizer UK Ltd where he worked on projects at all stages of development and was responsible for crafting the company position on non-clinical data for review by regulatory agencies. David was previously Director of DMPK and Drug Safety at Astex Therapeutics, a Drug Discovery Project Leader and Project Manager at GSK, and a Section Manager in DMPK at Rhône-Poulenc Rorer. His work involves integration of pharmacology, drug metabolism, pharmacokinetics and toxicology into an integrated package. He has a PhD in Biochemistry and a BSc in Cell Biology and Immunology from universities in the UK.

Topic lectured:

Seminar 5:

  • Juvenile animal studies

Avril Mankel

Santen GmbH

Avril

Dr. Avril Mankel has a PhD in Cell and Developmental Biology and is currently working at Santen GmbH. She was Senior Manager Regulatory Affairs at NDA Regulatory Service GmbH in Munich, Germany. After having worked for several years as post-doc at the University of Würzburg, the University Hospital and the Max-Planck-Institute for Molecular Genetics in Berlin she has been working for 14-years in the pharmaceutical industry now. She is an expert in the area of regulatory strategic advice for the development of medicinal products in Europe, submission and follow-up of MAA, full management for Scientific Advice and Protocol Assistance procedures, preparation of and advice on Briefing Books including questions and company positions for Scientific Advice and Protocol Assistance procedures, full management of Paediatric Investigation Plans (PIP) / Waiver / Deferral applications at EMA, preparation of documents required for the application of Paediatric Investigation Plans (PIP) / Waivers / Deferrals, preparation of documents for the application for Orphan Designations, preparation of documents for re-examination procedures after negative CHMP opinions, maintenance of approved licenses (follow-up measures, renewals, variations, implementation of regulations as required by EMA and national Agencies), preparation of IMPDs and IBs for Clinical Trial Applications. She acted as representative for companies at meetings with EMA and national agencies.

Topic lectured:

Seminar 5:

  • The Paediatric Investigation Plan (PIP)

Seminar1:

  • Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
  • Module 1 of the CTD
  • Module 2 of the CTD
  • Labeling, Package Leaflet and Summary of Product Characterisitcs (SmPC)
  • Risk Management Plan (RMP)

Geneviève Michaux

Hunton & Williams

Geneviève

Geneviève is a Belgian and French qualified attorney who focuses on issues surrounding the regulation of drugs, biologicals, medical devices, cosmetics and food in Europe, both at the Union and national level.
Geneviève specialises in European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labelling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Paediatrics Regulation. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
Geneviève is recognized as a leading regulatory lawyer in legal directories and by many organizations. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Topic lectured:

Seminar 5:

  • PIP-related legal aspects

Seminar 1:

  • Introduction into the European regulatory system
  • The European Pharmaceutical Legislation

3rd Annual Biopharmaceuticals Meeting:

  • Session 2: Biosimilar monoclonal antibodies in the EU and the US and Session 3: Drug-diagnostic companion development panel discussion

4th Annual Biopharmaceuticals Meeting:

  • Is the legal pathway ready to regulate drug-diagnostic companion developments?

5th Annual Biopharmaceuticals Meeting:

  • Protection of Biological Medicinal Products – Latest Developments

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Ashley Strougo

Astellas Pharma Global Development Europe

Ashley

Dr. Ashley Strougo is a scientist in pharmacokinetics modelling & simulation (M&S) at Astellas where she has been involved in different paediatric projects for a variety of indications. Ashley was born in Rio de Janeiro where she graduated as a pharmacist in 2001. In 2005 after research projects involving the use of PK-PD modelling in the field of pharmacology, clinical pharmacology and pediatrics she obtained her M.Sc. degree in Bio-Pharmaceutical Sciences at Leiden University in The Netherlands. Prior to joining Astellas in 2007 Ashley worked as a pharmacometrician to a consultancy company using M&S to identify and address key drug development issues. Since 2008 she is also a visiting scientist at Leiden University where she investigates different M&S techniques for bridging clinical data from adults to children as part of her PhD project.

Topic lectured:

Seminar 5:

  • Considerations for developing and executing the PIP
  • Paediatric Networks

Venue & Hotel

Venue and Hotel 2016

Munich, Germany.

Venue / Hotel details to be confirmed in due time.

Seminar 6: Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety

Date

Course 2014/2015:
03-05 June 2015*

Course 2015/2017:
February 2017*

Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety

Content

  • Pharmacovigilance concepts and specific aspects relevant to biologicals
  • Legal requirements and safety deliverables
  • Regulatory expectations
  • Risk management approach
  • Operational aspects:PhV system, business processes, project managment, quality oversight, saftey governance models, audits and inspections

Pharmacovigilance, i.e. the standard of constant monitoring of the safety of medicinal products after authorisation, is an important obligation of the marketing authorisation holder (MAH) and authorities. It requires constant exchange between companies and health authorities.

The EU legislation requires MAHs to provide the competent authorities with a description of their pharmacovigilance, risk management and quality system. Collecting, monitoring, assessing and evaluating information from healthcare professionals and patients on the adverse effects of medicinal products is conducted to identify new information about hazards associated with medicinal products and preventing harm to patients. Periodic Safety Reports (PSURs/PBRERs) and Risk Management Plans need to be generated and communicated regularly.

Depending on the signals observed, the MAH may have to implement actions for risk mitigation, for example changes to the SmPC or even measures on the marketing authorisation such as suspension or restriction of authorised therapeutic indications. The product information has to be kept up-to-date and communicated to health care professionals, patients and consumers in an effective and timely manner.

Learning Objectives

  • Explain the basis of the regulatory environment and processes to be followed related to pharmacovigilance
  • Discuss the principles and core activities involved in pharmacovigilance of medicinal products and the methods of pharmacoepidemiological studies
  • Understand and support the pre- and post-approval obligations to keep marketing authorisations valid in the EU
  • Provide the knowledge on the appropriate preparation of a Periodic Safety Report (PSUR/PBRER), Risk Management Plan (RMP) and in the implementation of risk minimisation
  • Learn to handle regulatory measures and processes such as an urgent safety restriction, a dear doctor letter, changes to the Safety Part of the SmPC, measures on the marketing authorization
  • Identify the relationship between PV systems, their quality systems and the regulatory frame work

Agenda

Flyer 2017

Agenda 2017

ALL SEMINAR 6 RECORDED PRESENTATIONS (WEBINARS)

February 2017

Munich, Germany

Course Leader:

Monika Pietrek, Pietrek Associates GmbH

Day 1

09.00-10.00 Introduction to the pharmacovigilance (Monika Pietrek, Pietrek Associates GmbH)

  • Are authorised products safe?
  • What do patients/consumers and physicians expect?
  • Biologicals: from vaccines to immunotherapy
  • Benefit/risk concept at the individual and the population level
  • Principles of surveillance
  • The legal framework conceptually: national legislation, EU legislation, CIOMS, ICH

10.00-10.45 Case Study (Monika Pietrek, Pietrek Associates GmbH)

10.45-11.15 Coffee break

11.15-11.45 Pharmacovigilance System and core PV processes I (Monika Pietrek, Pietrek Associates GmbH)

  • PSMF
  • ICSR

11.45-12.00 Questions and Answers

12.00-13.00 EU Regulatory requirements at time of authorisation (Christine Bendall, Pharview Ltd.)

  • How is the safety information presented in the relevant sections of the CTD submitted with the MAA
  • The PhV system and the role of the EU QPPV
  • Agreement on the labeling text, the SmPC
  • Post-authorisation commitments
  • Risk Management Plans

13.00-14.00 Lunch

14.00-14.30 Case Study (Monika Pietrek, Pietrek Associates GmbH)

14.30-15.30 EU Regulatory requirements post-authorisation (Christine Bendall, Pharview Ltd.)

  • Expedited reporting of safety information
  • Periodic Safety Reports (DSURs/PSURs/PBRERs)
  • Company Core Safety Information
  • Type II variations related to safety aspects
  • Urgent safety restrictions
  • Interaction of the company with agencies on safety aspects
  • Communication with the public

15.30-16.00 Coffee break

16.00-17.00 Pharmacovigilance concepts and core processes II (Monika Pietrek, Pietrek Associates GmbH)

  • Brief introduction into epidemiology
  • Methods of studying benefits and risks
  • Weighting evidence
  • Signal detection and investigation

17.00-17.45 Case Study (Christine Bendall, Pharview Ltd.)

17.45-18.00 Wrap-up

18.00 End of Day1

19.00 Get-together with food and wine

Day 2

09.00-09.30 Rehearsal Key Messages Day 1 (Christine Bendall, Pharview Ltd.Monika Pietrek, Pietrek Associates GmbH)

09.30-10.30 Pharmacovigilance concepts and core processes III (Glyn Belcher, PV Consultancy UG)

10.30-11.00 Coffee break

11.00-11.45 Case Study (Glyn Belcher, PV Consultancy UG)

11.45-12.15 Differences between EU and non-EU requirements with respect to PSMF, ICSR, periodic reports, RMP, product information (Christine Bendall, Pharview Ltd.)

12.15-13.00 Case Study (Monika Pietrek, Pietrek Associates GmbH)

13.00-14.00 Lunch

14.00-15.00 Implications of the EU PV legislation - Questions & Answers (Christine Bendall, Pharview Ltd.Glyn Belcher, PV Consultancy UG, Monika Pietrek, Pietrek Associates GmbH)

15.00-15.45 Benefit Risk Management in Practice (Glyn Belcher, PV Consultancy UG)

  • Benefit - Risk frame work
  • Risk management planning
  • Risk mitigation
  • Effectiveness of risk minimisation
  • Progress reports

15.45-16.15 Coffee break

16.15-17.00 Case Study (Students) (Glyn Belcher, PV Consultancy UG)

17.00-17.15 Case Study (Plenary) (Glyn Belcher, PV Consultancy UG)

17.15-18.00 Rehearsal Key Messages Day 1 and 2 (Glyn Belcher, PV Consultancy UGMonika Pietrek, Pietrek Associates GmbH)

18.00 End of Day 2

Day 3

09.00-09.45 Safety Communication and Transparency (Monika Pietrek, Pietrek Associates GmbH)

  • Risk communication to HCPs, patients/consumers and public at large
  • Erice Declaration
  • PRAC minutes
  • RMP summaries

09.45-10.45 Case Study (Monika Pietrek, Pietrek Associates GmbH)

10.45-11.15 Coffee break

11.15-12.00 PV Quality Management

  • PV system performance
  • Quality control
  • Audits and inspections
  • CAPA management
  • Quality oversight

12.00-12.30 Case Study (Monika Pietrek, Pietrek Associates GmbH)

12.30-13.00 Rehearsal Day 3 (Monika Pietrek, Pietrek Associates GmbH)

13.00-14.00 Lunch

13.00 End of Seminar 6

For Full Course students (Afternoon Day 3)

14.00-15.30 Introduction of homework; Questions & answers – Preparation for the exam

15.30-16.00 Coffee break

16.00-17.00 Exam

17.00 End of Seminar 6 for Full Course students

Speaker

Glyn Belcher

PV Consultancy UG

Glyn

Dr. Glyn Belcher has over 30 years experience in clinical development and drug safety in the pharmaceutical industry. Dr. Belcher qualified in medicine from Oxford and Cambridge and received his PhD in neuropharmacology from the latter university. After a number of years in hospital internal medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as Head of Cardiovascular Clinical Research and later as Head of a New Safety Department covering clinical development activities. Dr. Belcher then became Director of Clinical Drug Safety for Takeda Europe. His most recent full-time position in the industry was as Vice President of Drug Safety and Risk Management for all ex-USA territories of Biogen Idec. Dr. Belcher currently continues to work part-time as consultant safety physician to Biogen Idec and other companies as well undertaking an increasing commitment to teaching and training in the areas of clinical development and pharmacovigilance.

Topic lectured:

Seminar 6

  • Pharmacovigilance core processes III
  • Implications of the EU PV legislation - Questions & Answers
  • Benefit Risk Management in Practice
  • Case Studies

Christine Bendall

Pharview Ltd.

Christine

Christine Bendall qualified as a solicitor in England and Wales in 1985 and subsequently worked in private legal practice and (on secondment) for the Medicines Control Agency in the UK (now MHRA) specialising in the regulation of pharmaceuticals in the EU. She has a particular interest in clinical research and drug safety. She now works as a consultant to the pharma industry and also lectures regularly on university courses and at industry conferences on regulatory and legal matters. She has written for numerous publications, including contributing a chapter on the legal aspects of pharmacovigilance in “Detection of New Adverse Drug Reactions” (now in its 5th Edition; edited by, Talbot and Waller).

Topic lectured:

Seminar 6

  • EU PV regulatory requirements at time of authorisation
  • Case Study
  • EU PV regulatory requirements post-authorisation
  • Differences between EU and non-EU requirements with respect to PSMF, ICSR, periodic reports, RMP, product information
  • Implications of the EU PV legislation - Questions & Answers

Monika Pietrek

Pietrek Associates GmbH

Monika

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 25 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics.

Dr. Pietrek is the founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical and biotechnology industry. Her team has contributed to several marketing authorisation applications, risk management and pharmacovigilance projects as well as more than 300 GCP/GVP audits and mock inspections.

For more than 10 years she has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts. In this capacity Dr. Pietrek has been involved in the development and review of the EU PV legislation since the public consultation in 2006. She has published about Good Pharmacovigilance Practices, the PV terminology and the new EU PV legislation and PV quality management.

Dr. Pietrek has served as DIA volunteer for more than 20 years, as a speaker, session chair, theme leader and as a member of various programme committees for the annual conferences and workshops in North America and Europe, the Continuous Medical Education Committee and the Advisory Council Europe. She is a member of the Editorial Board of the Therapeutic Innovation and Regulatory Science (TIRS) Journal.

Since 2010 Dr. Pietrek has been coordinating and teaching the PV Module of the MSc in Regulatory Affairs for Biopharmaceuticals (www.eucraf.eu) in collaboration with the University of Strasbourg.

Her interests are benefit/ risk assessments of medicinal products and process optimisation in clinical research and pharmacovigilance, balancing solutions to meet patient needs and public health decisions as well as to support innovative drug development. More details are available on www.pietrekassociates.com.

Topic lectured:

Seminar 6:

  • Introduction to the Pharmacovigilance
  • Pharmacovigilance System and core PV processes I
  • Pharmacovigilance concepts and core processes II
  • Implications of the EU PV legislation - Questions & Answers
  • Safety Communication and Transparency
  • PV Quality Management
  • Case Studies

2nd Annual Biopharmaceuticals Meeting:

  • Impact of the new Pharmacovigilance Legislation on Biopharmaceuticals – procedures, processes, impact

3rd Annual Biopharmaceuticals Meeting

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Venue & Hotel

Venue and Hotel 2017

Munich, Germany.

Hotel details to be confirmed in due time.

Seminar 7: The roles of the supervising authorities and the essential characteristics of quality systems

Date

Course 2014/2015:
22-24 July 2015*

Course 2015/2017:
May 2017*

The roles of the supervising authorities and the essential characteristics of quality systems

Content

  • Principles and underlying legislation for the establishment of GMP, GLP, GCP
  • GMP authorization - procedures in the EU and requirements for third countries
  • The supervising authorities - role of national inspectorates and EMA
  • Experience with GMP - inspections by inspectorates from USA, EU, Japan
  • Compliance and steady optimization of production and processes
  • Role of EDQM and OMCLs
  • Certificates of suitability
  • The Rapid Alert System

Companies manufacturing, testing or distributing active ingredients or medicinal products, clinical centres conducting clinical trials and research organisations performing studies need to follow common standards of quality system requirements. The quality system is supervised by national inspectorates who increasingly co-operate globally. If the establishment inspected is found to be compliant with the relevant requirements a license is issued as an authorisation to manufacture, test or distribute the medicinal product or active ingredient.

With the introduction of ICH Q 8, 9 and 10 principles, and with the increasing global trade of active ingredients and products, quality systems become more and more important in ensuring their quality.

The primary purpose of a quality system is to ensure that adequate quality standards are used and maintained. The Good Manufacturing Practice (GMP) applies to the manufacture and control of active ingredients and final dose forms of pharmaceuticals and their clinical supply, the Good Laboratory Practice (GLP) to non-clinical investigations of new compounds, the Good Clinical Practice (GCP) to the conduct of clinical studies, the Good Distribution Practice (GDP) to the storage and distribution of medicinal products.

Learning Objectives

  • Understand the characteristics of a quality system and the particulars of the different types of GxP
  • Understand how regulatory affairs is connected to the Quality System
  • Become familiar with the legislation and guidelines defining the rules for GxP
  • Learn how national inspectorates including those from different regions collaborate on facility inspections and which role play the individual stake holders
  • Understand how supervision is executed and inspections are conducted
  • Understand the function and responsibilities of the Qualified Person
  • Recognise what is special with GMP and GDP for biopharmaceuticals
  • Understand ICH guidelines Q 8, 9 and 10

Agenda

Flyer 2017

Agenda 2017

May 2017

European Directorate for the Quality of Medicine & HealthCare (EDQM)

Council of Europe

7 Allée Kastner

67081 Strasbourg, FRANCE

Course Leader:

Ralf Hess, Parexel

Day 1

09.00 - 09.15 Welcome and introduction (Ralf Hess, Parexel)

09.15 - 11.00 European Directorate for the Quality of Medicines and Healthcare (EDQM) (Susanne Keitel, Director EDQM)

  • Role
  • Structure
  • Activities
  • Certificate of suitability

11.00 – 11.30 Coffee break

11.30 – 12.45 Characteristics of quality management systems – an introduction (Ralf Hess, Parexel)

  • Which quality management systems apply in the EU and how they are regulated and executed
  • Who supervises the companies in the EU and in third countries and how this supervision is authorized and documented

12.45 - 13.45 Lunch

13.45 - 15.00 The principles of GMP (Ralf Hess, Parexel)

  • Legal requirements for obtaining a manufacturing authorisation or an authorisation for importation
  • Obligations of a holder of a manufacturing authorisation or an authorisation for importation

Company’s responsibility in batch release and The Qualified Person

  • The Qualified Person for marketed products or Investigational Medicinal Products (IMPs)

Special GMP considerations for biopharmaceuticals including advanced therapies

  • What is special for biopharmaceuticals
  • GMP for starting materials
  • GMP of blood products and blood components
  • Are biopharmaceuticals subject to counterfeits

15.00 – 15.30 Coffee break

15.30 - 16.30 continued

16.30 - 18.00 The Regulatory Affairs department at the interphase (Gabriele Dallmann, EUCRAF and Ralf Hess, Parexel)

  • Which role the Regulatory Affairs department has at the interface of GMP authorization of manufacture and testing, GLP compliance of pre-clinical testing and GCP compliance of clinical trials
  • How supervision works – when an inspection is required – who performs the inspections – which authorization documents are required and how they are maintained – when and how the documents are submitted to agencies for CTA and marketing authorization

18.00 End of Day 1

19.00 Get-together with food and wine

Day 2

09.00 - 10.30 Experience with inspections conducted by the different inspectorates from Europe, U.S. and Japan (Bernd Raffelsberger, formerly Pfizer)

How an inspection is performed

10.30 – 11.00 Coffee break

11.00 – 12.30 continued

12.30 – 13.30 Lunch

13.30 – 15.00 Surveillance of medicines through testing in the EU/Europe (Karl-Heinz Buchheit and Catherine Milne, EDQM)

  • OMCL Network
  • CAP testing program and Market Surveillance
  • Official Control Authority Batch Release (OCABR)

15.00 – 15.30 Coffee break

15.30 – 16.30 The principles of GLP (Ralf Hess, Parexel)

  • Recording, archiving, reporting investigations
  • Global Implementation and mutual recognition
  • The competent authorities

16.30 - 17.30 The principles of GDP (Ralf Hess, Parexel)

  • Maintenance of the level of quality throughout the distribution chain

The Rapid Alert System

Product defects

Recalls

17.30 End of Day 2

For Full Course students:

Introduction of Homework Seminar 7

Day 3

09.00 – 10.30 The principles of GCP (Dagmar Chase, Clinrex GmbH)

  • Introduction

o Why we have GCP

o Declaration of Helsinki

o The ICH GCP process

o Ethical and scientific principles in clinical trials to ensure protection of trial subjects and integrity of trial results

  • The responsibilities of sponsors, e.g.

o Quality Control and Quality Assurance
(Monitoring and Auditing)

o The interface to service providers

o GCP information flow and reporting requirements

  • The responsibilities of investigators, e.g.

o How to delegate trial tasks within a team

o Protocol adherence

o Informed Consent Procedure

o Source Data and Case Report Forms (CRFs)

o GCP information flow and reporting requirements

  • Typical GCP Inspection Findings

10.30 - 11.00 Coffee break

11.00 - 12.30 continued

12.30 - 13.15 Lunch

13.15 - 14.30 continued

14.30 End of Seminar 7

For Full Course students:

14.30 - 14.45 Coffee Break

14.45 - 15.30 Questions & Answers – Group work as preparation for the exam

15.30 - 16.30 Written exam

17.00 End of Seminar 7 for Full Course students

Speaker

Dagmar Chase

Clinrex GmbH

Dagmar

Dr. Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine at the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany.
Dr. Chase co-founded the company GMI, a full service CRO for clinical trials phase II – IV, in 1983. Besides developing GMI into one of the largest CROs in Germany, Dr. Chase concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry.
In order to be able to offer international services to GMI’s clients she was instrumental in the merger of GMI with the US-based CRO Kendle International Inc in 1997, holding the position of Vice President until the beginning of 2004.
In March 2004 Dr. Chase started up Clinrex, a consultancy firm for clinical research. In addition to providing training and consulting for all aspects of GCP and Quality Management, she focuses on GCP gap analyses and inspection readiness programs, management of DSMBs/DMCs  and project coordination  e.g. helping sponsors to identify and manage the right partners in the EU (legal representation, CROs, etc.). Dr. Chase is President of the German CRO Association BVMA e.V. (Bundesverband Medizinischer Auftragsinstitute) and Vice President of the EU CRO Federation (EUCROF).

Topic lectured:

Seminar 7:

  • The principles of GCP

Ralf Hess

PAREXEL

Ralf

Dr. Ralf Hess holds a PhD degree in virology and immunology together with a Masters degree in biology (genetics, microbiology, cell biology and organic chemistry) from the University of Freiburg, Department of Virology, Germany and subsequently held an academic position in the Department of Virology between 1987 and 1996 during which time he focused on medical virology, diagnostics and epidemiology. Ralf has extensive experience in academia, industry and the regulatory environment and is a Principal Consultant at PAREXEL and is affiliated with ASM (American Society for Microbiology) since 1996, ESCV (European Society for Clinical Virology) since 2004, GfV (Gesellschaft für Virologie = Society for Virology, DE, AUT, CH) since 1990, DGHM (Deutsche Gesellschaft für Mikrobiologie und Hygiene, German Society For Microbiology and Hygiene) since 1999, BioValley Deutschland e.V. (Freiburg, Germany) since 1996, a member of European QP (Qualified Person) Association since 2007, a member of European Society of Virology (new organization (04/09) since June 2009, an ECA (European Compliance Academy) and PDA (Parenteral Drug Association) member. Prior to his position at PAREXEL, Ralf was the Chief Scientific Officer at HISS Diagnostics (1996 to 2007), an in-vitro diagnostic medical device manufacturer where he was responsible for R&D, manufacturing as well as being Head of Regulatory Affairs. Ralf has extensive knowledge of medical device regulations (ISO, certification and accreditation), GLP, GCLP and GMP and was registered as a Qualified Person with Swiss Medic (2007-2012). In the time that Ralf has been at PAREXEL (more than 7 years) his expertise in virus safety and manufacturing has meant he has been actively involved in identifying and resolving competitive GMP compliance issues, advising on biological assay selection and validation as well as assessing biosafety concerns for various biotechnology products including biosimilars, and vaccines. Ralf is also a recognized expert in immunogenicity and has extensive knowledge of biological assay platforms and their application to immunogenicity testing and assessments. Ralf understands EU GMP and regulatory affairs legislation for drug and devices and provides strategic compliance services for drug, device and drug-device combination product manufacturer. He recently became an APIC certified Auditor (eff. from June 5, 2014) for ICHQ7 Biologics.

Topic lectured:

Seminar 7:

  • The principles of GLP

Susanne Keitel

EDQM

Susanne

Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Her work experience includes 10 years in pharmaceutical development in industry, with five years as Department Head of ”Pharmaceutical Development/Oral Dosage Forms“ at the former Schering AG, Berlin. From 1997 to 2005, she held the position of Division Head Pharmaceutical Quality at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. She additionally served as Acting Head of the Division European Procedures from November 2003.

From July 2005 to October 2007, Susanne Keitel was Head of EU, International Affairs at BfArM. During her time with BfArM, she represented the agency in a number of EU committees, including the Joint CHMP/CVMP Quality Working Party (QWP), the EMEA Paediatric Working Party and the European Commission’s Notice to Applicants Group. She was actively involved in the International Conference on Harmonization (ICH), where she acted as the EU topic leader and rapporteur for the ICH guidelines on stability testing and pharmaceutical development. On a national level, she was from 2001 to 2007, Chair of the German Pharmacopoeia and the German Homeopathic Pharmacopoeia. Since October 2007, Susanne Keitel is Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM) of the Council of Europe in Strasbourg.

She also lectures in the postgraduate course “Master of Drug Regulatory Affairs” at Bonn University, where she is responsible for the module on the quality dossier. In 2009, Dr. Keitel was elected as corresponding Foreign Member at the French Académie Nationale de Pharmacie.

Topic lectured:

Seminar 7:

  • European Directorate for the Quality of Medicines and Healthcare (EDQM)
  • Agency´s batch release
  • OMCL network
  • Official Control Authority Batch Release (OCABR)
  • CAP testing
  • PICS and WHO

Bernd Raffelsberger

Formerly Pfizer

Bernd

Dr. Raffelsberger holds a diploma in Chemistry from the Albert-Ludwig University of Freiburg, Germany and a Ph.D. in Organic Chemistry and Mass Spectocrospy. He joined Pfizer in 1979 as a Lab Manager for Instrumental Analytics. Over the years responsibilities increased in the area of Method Validation, Stability Management and Quality Control. In 1994 Bernd became Head of the Quality Design group of Warner- Lambert Freiburg and in 1998 Head of Quality Design Europe. Between 2000 and 2004 main responsibilities were Head of Quality Assurance and Head of Analytical Research in Product and Process Development for new pharmaceutical products. From 2004 until 2013 he was Head of the Quality organization of Pfizer Freiburg. Since 2013 he worked for Pfizer Freiburg in a new function as advisor for Quality- and GMP-projects.

Topic lectured:

Seminar 7:

  • Experience with inspections conducted by the different inspectorates from Europe, U.S. and Japan
  • How an inspection is performed

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Catherine Milne

EDQM

Catherine

Catherine Milne received her doctoral degree from the University of Toronto, Department of Molecular and Medical Genetics in 1994 and subsequently conducted independent research as a post-doctoral fellow at the Medical Research Council, Laboratory of Molecular Biology in Cambridge, England in the field of molecular genetics and developmental biology. Since 1999 she has been at the Council of Europe, European Directorate for the Quality of Medicines & HealthCare (EDQM) where she is the scientific officer responsible for the Networks of Official Medicines Control Laboratories (OMCLs) involved in Official Control Authority Batch Release (OCABR) of human vaccines, medicinal products derived from human blood and plasma, and veterinary vaccines respectively. She is also involved in the EDQM Biological Standardisation Programme (BSP) and has coordinated a number of projects for the standardisation of methods and reference materials for the evaluation of human and veterinary vaccines and medicinal products derived from human blood and plasma with a focus on the 3Rs (reduction, refinement and replacement of animal use).

Topic lectured:

Seminar 7

  • Surveillance of medicines through testing in the EU/Europe

- OMCL Network
- CAP testing program and Market Surveillance
- Official Control Authority Batch Release (OCABR)

Karl-Heinz Buchheit

EDQM

Karl-Heinz

Dr. Karl-Heinz Buchheit obtained his degree in pharmacy from the Johann-Wolfgang-Goethe University in Frankfurt/M. (Germany) and his Ph.D. in pharmacology in 1984 from the same university. From 1984 until 1999 he worked as research scientist and group leader in preclinical pharmacology for Novartis/Sandoz in Basel (Switzerland). From December 1999 to August 2013, he was Deputy Head of the Department Biological Standardisation, OMCL Network & HealthCare at the EDQM (Council of Europe, Strasbourg, France) and secretary of the Steering Committee of the Biological Standardisation Programme. Since August 2013 he is Head of the same department which is responsible for the activities of the EDQM in the fields of biological standardisation, the OMCL network, blood transfusion, organ-, tissue and cell transplantation, pharmaceutical care, anti-counterfeit measures and consumer health protection.

Topic lectured:

Seminar 7

  • Surveillance of medicines through testing in the EU/Europe

- OMCL Network
- CAP testing program and Market Surveillance
- Official Control Authority Batch Release (OCABR)

Venue & Hotel

Venue 2017

EDQM Council of Europe

7 allée Kastner, CS 30026,

67081 Strasbourg, France

Tel. +33 (0)3 88 41 30 30

Fax +33 (0)3 88 41 27 71

Hotel 2017

Hotel details to be confirmed in due time.

Seminar 8: Scientific advice, regulatory strategy and health technology assessment

Date

Course 2014/2015:
02-04 (05) September 2015*

Course 2015/2017:
July 2017*

Scientific advice, regulatory strategy and health technology assessment

Content

  • Regulatory strategy and global positioning of newly developed and existing products
  • Pre-marketing interactions with regulatory agencies: scientific advice and pre-IND
  • Concepts and tools to support regulatory processes
  • Regulatory strategy for the introduction of changes in the manufacturing process
  • Intellectual Property Rights
  • Health Technology Assessment

According to the records of the EMA, constantly 25% of newly developed medicinal products submitted to the centralised authorisation procedure in Europe fail. This high failure rate is remarkable taking into account all the efforts installed in Europe within the 15 years from the time the EMA had been inaugurated. Numerous incentives are in place to stimulate regular pre-submission interactions with agencies to discuss the compliance of development programs with regulatory principles. Regulatory guidelines for all areas of drug development are available describing the regulatory standards. In order to translate these efforts into higher success rates of marketing authorisations an essential component of the overall regulatory strategy is the establishment of regular cross-functional interactions between teams of drug discovery and development, pharmaceutical development, marketing. Regulatory affairs should play an important role in this process. Health technology assessment is another increasingly important aspect of drug development, which requires earlier consideration in development concepts in the future. The seminar addresses concepts and tools by which strategic bridging is established and conducted efficiently in practice throughout the life cycle of the medicinal product.

Learning Objectives

  • Reduce critical set backs in registration procedures by a successful scientific advice strategy and anticipating questions from regulators
  • Lead and conduct appropriate scientific advice activities
  • Understand how to plan and organize pre-authorisation interactions with regulatory authorities
  • Understand the scientific advice process at the EMA and the pre-IND process at the FDA and the relevant dossier requirements
  • Learn to plan, establish and conduct regular cross-functional regulatory forums from the early stage of development on
  • Understand the principles of Health Technology Assessment and its implications on development programms and regulatory strategy

Agenda

Flyer 2015

Agenda 2015

ALL SEMINAR 8 RECORDED PRESENTATIONS (WEBINARS)

Day 1: Wednesday, 02 September 2015

09.15 - 09.30 Welcome and introduction (Gabriele Dallmann, EUCRAF)

09.30 - 11.00 Regulatory Strategy (Jacques Mascaro, Merck Serono)

  • What is a regulatory stategy and when is it needed?
  • Which implication a global development has for a company and for the agencies involved?
  • Stakeholder and liaison functions
  • Active participation in development of new requirements
  • Choice of submission type and procedure
  • Management of product life cycle
  • Regulatory risk evaluation

11.00 - 11.30 Coffee break

11.30 - 12.45 continued

12.45 - 13.45 Lunch

13.45 - 15.30 A cross-functional strategic forum to support decision-making for regulatory processes (Susanne Heiland-Kunath, Takeda)

  • Life cycle of development projects
  • Regular interactions of regulatory affairs, clinical development, marketing, pharmaceutical development, pharmacovigilance
  • Tools, teams and deliverables
  • Preparation, briefing book, questions, discussions, minutes, internal communication
  • Gap analysis of data packages available for regulatory submissions
  • Involvement of external experts

15.30 - 16.00 Coffee break

16.00 - 17.30 Regulatory strategy for the introduction of changes in the manufacturing process (Sibylle Kaiser, Biotest AG)

  • What important is in the manufacturing process
  • Planning changes of manufacture and comparability projects
  • When to demonstrate consistency
  • When to introduce a pre-clinical and clinical bridging study
  • Change control processes in practice

17.30 End of Day 1

18.45 Get-together with food and wine

Day 2: Thursday, 03 September 2015

09.15 - 10.30 HTA as a new element of the regulatory strategy - national requirements and European initiatives (Bruno Flamion, NDA Regulatory Advisory Board, University of Namur)

  • Reimbursement in Europe
  • Considerations on how to design clinical development programmes to be used for approval and HTA

10.30 - 11.00 Coffee break

11.00 - 11.30 continued

11.30 - 12.30 The regulatory affairs department at the interphase – cooperation with the market access department and its role in HTA (Beate Schäfer, Bristol Myers Squibb)

12.30 - 13.00 Discussion round on HTA

13.00 - 14.00 Lunch

14.00 - 15.30 An introduction about patenting biopharmaceuticals and freedom-to-operate studies (Denis Bourgarel, European Patent Attorney & French Patent Counsel)

  • What can be patented? The patentability criteria
  • For what purposes? What would by the scope of my patent exclusivity? Differences with data exclusivity?
  • The consequence of third party existing patent rights for my drug development
  • Patenting mAb as a case

15.30 - 16.00 Coffee break

16.00 - 17.15 Regulatory protection of medicinal products (Heike Wachenhausen, Wachenhausen Rechtsanwälte, formerly Novartis)

  • Regulatory data exclusivity and lifecyle management
  • PIP compliance and SPC extension
  • Market exclusivity for orphan drugs

17.15 End of Day 2

For Full Course students:

17.15 - 18.00 Introduction of Homework

Day 3: Friday, 04 September 2015

09.15 - 10.15 Strategic considerations on interactions with regulatory agencies (Simon Day, CTCT)

  • Introduction
  • Examples of how to plan national and EMA scientific advice activities

10.15 - 11.00 Scientific advice from national competent authorities (Jan Müller-Berghaus, Paul-Ehrlich-Institut)

  • Experience and process followed at the German competent authority, the Paul-Ehrlich-Institut

11.00 - 11.30 Coffee break

11.30 - 13.00 Interactions with regulatory agencies in the EU to receive scientific advice (Jan Müller-Berghaus, Paul-Ehrlich-Institut)

  • The procedure of the European scientific advice at the EMA
  • Process and experience
  • Documentation, discussion meeting
  • Follow-up and clarification
  • EU/US paralell Scientific Advice
  • The EMA´s Innovation Task Force

13.00 - 14.00 Lunch

14.00 - 15.30 Interactions with FDA in the pre-IND process (Benita von Glahn, Boehringer Ingelheim)

  • Pre-phase I and post-phase II meetings
  • Preparation, documentation, meeting, telephone conference, written procedure

15.30 - 16.00 Coffee break

16.00 - 17.00 Interactive panel discussion: Interactions of companies and agencies in the development of biopharaceuticals

Benita von Glahn

Jan Müller-Berghaus

Simon Day

17.00 End of Seminar 8

For Full Course students:

Saturday, 05 September 2015

09.15 - 10.45 Preparation for the exam

10.45 - 11.15 Working lunch

11.15 - 12.15 Exam

12. 15 End of Seminar 8 for Full Course students

Speaker

Simon Day

Clinical Trials Consulting & Training Limited

Simon

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice / end of Phase II meetings and preparations for oral explanations and advisory committees.
He is a former president of the International Society for Clinical Biostatistics; he is joint editor of Statistics in Medicine and previously joint editor of the Journal of the Royal Statistical Society. He is an associate editor of Pharmaceutical Statistics and British Journal of Clinical Pharmacology. In 2012 he was elected a Fellow of the Society for Clinical Trials.
He has published widely in statistical and medical journals, is author of one book “Dictionary for Clinical Trials” and is joint editor of the “Textbook of Clinical Trials”, both published by Wiley.
He has served on a variety of data monitoring committees both for industry- and government-sponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He is also vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on development and regulatory assessment of orphan drugs.

Topic lectured:

Seminar 4.2:

  • The principle of clinical development of biopharmaceuticals
  • Group work: Benefit-risk assessment for monoclonal antibodies

Seminar 8:

  • Strategic considerations on interactions with regulatory agencies

Seminar 9:

  • Agency meetings exam

Coaching Event: Agency meetings

  • Opportunities of agency meetings in the EU and US
  • Scientific Advice Meetings during development

Bruno Flamion

NDA Regulatory Advisory Board

Bruno

Bruno Flamion is a Belgian national, MD/PhD from the University of Brussles, specialist in internal medicine and nephrology and full Professor of physiology and pharmacology at the University of Namur, Belgium (since 1998). He has been a medical and pharmacological expert for the Belgian Federal Agency for Medicines and Health Products (FAMHP) for 12 years and has worked for the European Medicines Agency (EMA) in London for 10 years, acting as CHMP member, vice-chair of the Pharmacogenomics Working Party, chair of the Pharmacokinetics group, and chair of the Scientific Advice Working Party for 6 years (2005 - 2010).

Bruno Flamion has also chaired the Committee for Reimbursement of Medicines in Belgium (2010 - 2012). This Committee is part of the National Insitute for Health and Disability Insurance. Bruno is a member of Regulatory Advisory Boards of CIRS (Center for Innovation in Regulatory Science) and NDA. Bruno's interests lie in clinical pharmacology, drug development (both regulatory and health technology assessment/reimbursement aspects), patient care and basic research.

Topic lectured:

Seminar 8:

  • HTA as a new element of ther regulatory strategy - national requirements and European initiatives
  • Reimbursement in Europe
  • Consideration on how tzo design clinical development programmes to be used for approval and HTA

Susanne Heiland-Kunath

Takeda Pharmaceuticals International GmbH

Susanne

From June 2014 Susanne Heiland-Kunath is Head of Regulatory Affairs Europe, Vaccines Business Unit. She transitioned from heading Global Development Regulatory Therapeutic Area Immunology and Respiratory in Takeda. She has a working experience of more than 14 years in the field of international regulatory affairs for development products at Takeda. She has been involved in the development, approval and lifecycle management of products in different areas such as Gastroenterology, Respiratory and Immunology diseases, including the development of monoclonal antibodies in Rheumatoid Arthritis. She has gained substantial experience in European Scientific Advice procedures and FDA meetings for several development products, as well as in MAA submissions and approvals under the Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure. This includes the successful Rx-to-OTC switch of a gastroenterology product via the Centralised Procedure. She also has been involved in the MAA submissions and registration procedures in more than 70 countries for a key respiratory product at Takeda. She holds a PhD in Biology from the University of Konstanz, Germany. After her PhD thesis in Molecular Genetics she went to Beijing, China, with a scholarship by the DAAD for 1 year, which included working at Bayer Healthcare Beijing.

Topic lectured:

Seminar 8:

  • A cross-functional strategic forum to support decision-making for regulatory processes

Jacques Mascaro

Merck Serono

Jacques

Dr. Jacques Mascaro holds a PhD in Biology from University of Pharmacy in Aix-Marseille II. He started to work in Regulatory Affairs in 1989 as Manager of Regulatory Compliance Europe at Du Pont Pharma S.A. in Geneva. From 1994 to 1996 he worked as Chief Technical Officer International at Collagen International Inc.. Afterwards he became Senior Vice President for Pharmaceutical Affairs at H. Lundbeck AS. 1999 he changed to the Drug Information Association in Switzerland where he was European Managing Director. From 2001 to 2004 he was Director of European Regulatory Affairs at Johnson & Johnson. After 3 years with F. Hoffmann-La Roche as Head of European Regulatory Affairs Jacques Mascaro was Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Quality Assurance at Elan Pharma International. He is currently Senior Vice President, Global Regulatory & Quality Assurance at Merck Serono.

Topic lectured:

Seminar 8:

  • Regulatory strategy

Jan Müller-Berghaus

Paul-Ehrlich-Institut

Jan

Dr. Jan Müller-Berghaus is co-opted CHMP member and clinical assessor at the Paul-Ehrlich-Institut. He was Head of Section Monoclonal and Polyclonal Antibodies at the Paul-Ehrlich-Institut, Germany. He started his career in 1990 as Intern in Pediatrics at the Universtity of Cologne. From 1992 to 1996 he worked there as Resident in Pediatrics. In 1996 he became Fellow in Pediatric Oncology. Two years later he moved to the USA, where he worked as Research Associate at the Department of Surgery at the University of Pittsburgh. In 2002 he became Senior Research Associate at the German Cancer Research Center at the University of Heidelberg. In 2005 he changed to the Paul-Ehrlich-Institut, where he is still working.

Topic lectured:

Seminar 8:

  • Interactions with regulatory agencies in the EU to receive scientific advice
  • Scientific Advice from National Competent Authorities
  • Interactions of companies and agencies in the development of biopharmaceuticals

2nd Annual Biopharmaceuticals Meeting:

  • Potential future regulatory pathways taking into account the European HTA requirements

3rd Annual Biopharmaceuticals Meeting:

  • How to incorporate HTA considerations into clinical development – strategy, company structure, stakeholders involved, scientific considerations for future clinical developments of incorporating criteria to determine additional benefit

4th Annual Biopharmaceuticals Meeting:

  • EMA contributions to facilitate innovation: current state of the benefit-risk projectand the pilot project on adaptive licensing
  • Case study: the approval of the first biosimilar monoclonal antibody
  • Thoughts on the value of clinical trials to demonstrate similarity: what is their role in the overall similarity package and what do they show us

5th Annual Biopharmaceuticals Meeting:

  • How is the approved SmPC understood by the HTA Bodies and why does it matter

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Heike Wachenhausen

Wachenhausen Rechtsanwälte

Heike

Heike provides advice across the full range of regulatory matters relating to medicinal products and medical devices on German and European level with particular focus on development, marketing authorization and product safety (vigilance).

Heike has been working as a regulatory lawyer for fourteen years. She started her career in the practice group “Healthcare, Life Sciences and Chemicals” in the Düsseldorf office of Clifford Chance and for six years she worked with law firm Sträter in Bonn before she became Head Legal Regulatory & Development in the legal department of Novartis AG based in Basel, Switzerland, in 2009. In 2011, Dr Wachenhausen decided to return to Germany in order to set up her own law firm, which would specialize in pharmaceutical law and medical devices law and to use her many years of experience advising industrial companies as an in-house specialist or as an external legal adviser.

Heike holds a PhD in law. Her doctoral thesis deals with clinical trials with persons incapable of giving informed con sent.

Heike is the author of various publications and a speaker at specialist conferences. She annotates, for example, Sections 40 ff. of the German Drug Act (AMG) on clinical trials of medicinal products on human beings in the AMG commentary (eds. Kügel/Müller/Hofmann) and is editor of the Wiesbaden commentary on medical devices law (eds. Hill/Schmitt).

Languages: German, English

Topic lectured:

Seminar 8:

  • Regulatory protection of medicinal products

Denis Bourgarel

European Patent Attorney & French Patent Counsel

Denis

Dr Denis Bourgarel is a European patent attorney and French patent counsel. He has been working in the patent field for 13 years. He was trained in a patent law firm based in Paris, where he qualified as a European Patent attorney to represent clients before the European Patent Office. He then worked as in-house patent attorney at the patent department of an international pharmaceutical company based in Basel where he handled due diligence, freedom-to-operate and patent portfolio management related to biologics, biomarkers and research tools. Since 2010, he has joined Cabinet Plasseraud as patent counsel, and is specialized for advising in the biotech, pharmaceutical and biochemistry fields. Denis Bourgarel supports clients (universities, start-ups, industry) for patent drafting and global prosecution, and also represents them in opposition and appeal proceedings before the European Patent Office.

Topic lectured:

Seminar 8:

  • An introduction about patenting biopharmaceuticals and freedom-to-operate studies

Beate Schäfer

Bristol-Myers Squibb

Beate

Beate Schäfer studied pharmacy at the University of Tübingen and graduated in 1987.

She has been working for more than 20 years in different areas of Regulatory Affairs and pharmaceutical Quality Assurance in national and European positions.

More than 10 years she worked for SmithKline Beecham/Glaxo SmithKline, finally as Associate Director Regulatory Affairs and Quality Assurance, Germany. Thereafter she had several European positions as:

  • Head of Regulatory Affairs EMAI at Wrigley (1 year),
  • Head of Regulatory Affairs Europe at Santen (6 years)
  • European Head Regulatory Affairs Cardiovascular & Metabolism at Novartis (2,5 years)

In 2011 she joint Bristol-Myers Squibb Germany as Head of Regulatory Sciences and pharmaceutical Quality Assurance. Since 2014 she is in addition representing Regulatory in a global brand teams of BMS .

Topic lectured:

Seminar 8:

  • The regulatory affairs department at the interphase – cooperation with the market access department and its role in HTA

5th Annual Biopharmaceuticals Meeting:

  • How is the approved SmPC understood by the HTA Bodies and why does it matter

Benita von Glahn

Boehringer Ingelheim Pharma GmbH & Co. KG Regulatory Affairs Biosimilars

Benita

Pharmacist by training with PhD in pharmaceutical chemistry from University of Heidelberg, Germany. Started in pharmaceutical industry in 1998, in German Drug Regulatory Affairs at Mundipharma, Limburg (Lahn), Germany. In 2002 took a position in Regulatory Affairs Immunology at Abbott. From July 2007 lead the International Regulatory Affairs Team Immunology and was appointed in Jan 2011 as TA Head for Humira within Global Regulatory Strategy. Joined Boehringer Ingelheim in February 2013 as Head of Development Regulatory Affairs, Biosimilars. Master’s degree of Drug Regulatory Affairs from University of Bonn in 2008 and a Special Pharmacist degree for Drug Information in 2007.

Topic lectured:

Seminar 8:

  • Interactions with FDA in the pre-IND process

Seminar 2:

  • Regulatory Affairs in Japan

Sibylle Kaiser

Biotest Pharma GmbH

Sibylle

Dr. Sibylle Kaiser is heading the Group Corporate Regulatory Affairs Development at Biotest AG. She is a Regulatory Affairs professional with more than 12 years of pharmaceutical industry experience. In her current position she is involved in planning and implementation of regulatory strategies for drug development programs and product enhancement plans. She has expert knowledge of regulatory requirements (CMC, preclinical, clinical) for development and life cycle management of antibodies, antibody-drug-conjugates, and plasma-derived products. Therapeutic area experience includes immunodeficiency and haematologic diseases, oncology and prevention of virologic infection. Prior to joining Biotest she was working for Abbott GmbH and Aventis Pharma. She holds a PhD in cancer research, a diploma in Molecular Biology and a Master Degree in Drug Regulatory Affairs (MDRA).

Topic lectured:

Seminar 8

  • Regulatory strategy for the introduction of changes in the manufacturing process

Venue & Hotel

Venue and Hotel 2017

Munich, Germany.

Hotel details to be confirmed in due time.

Seminar 9: Good Regulatory Affairs practice: communication skills, project management and tools for the daily practise

Date

Course 2014/2015:
08-09 (10) October 2015*

Course 2015/2017:
October 2017*

Good Regulatory Affairs practice: communication skills, project management and tools for the daily practise

Content

  • Good regulatory practice
  • Function, skills and performance of a regulatory affairs professional
  • Cross-functional communication and interaction
  • Agency meetings in practice
  • Project management, time lines
  • Data and document management
  • Tools for daily practice and conferences to attend

Knowledge of the subject matter is required to understand the science of the product under development, to facilitate the adoption of regulatory principles and to integrate teams involved and information gained in this process. Regulatory affairs is thus determined by its interdisciplinary character requiring individuals committed to processes which are deadline-determined. Scientific and administrative requirements need to be integrated into the development concept, gap analysis of data packages as compared to regulatory requirements are conducted, teams need to be integrated internally and the interphase between the company and health authorities needs to be handled appropriately. The conduct of an agency meeting is trained at this seminar. Particular capabilities in preparing regulatory documents are required since style and content are special due to the orientation along regulatory requirements. Project management skills, time line awareness, interaction and communication skills are essential. Strategic planning, the ability to anticipate problems, to analyse complex situations and to offer the optimal strategy to achieve a certain strategic goal in a timely manner become important as the career progresses. These skills are necessary to communicate adequately with partners internally and externally. Certain tools for daily work are presented and ways to exchange with colleagues are discussed.

Learning Objectives

  • Understand the role and responsibility of the regulatory affairs’ professional
  • Understand the essential features of Good Regulatory Practice (GRP)
  • Understand the importance of interactions and interfaces for the overall success of a project – cross-regional, cross-functional, company-agency
  • Learn how to develop negotiation skills, to solve conflicts and to compromise adequately
  • Understand and conduct data and project management in regulatory affairs
  • Understand the important media tools to be regularly applied
  • Gain presentation skills for internal and external meetings, inclusive agency meetings
  • Get knowledge of the essential websites, media tools, industry associations and conferences relevant for regulatory affairs

Agenda

Flyer 2015

Agenda 2015

ALL SEMINAR 9 RECORDED PRESENTATIONS (WEBINARS)

Day 1: Thursday, 08 October 2015

09.15 - 09.30 Welcome and introduction (Gertrud Thormann, The Hst Consulting Network GmbH)

09.30 - 10.30 Conducting effective meetings (Gabriele Dallmann, EUCRAF and Biopharma Excellence; Gertrud Thormann, The Hst Consulting Network GmbH)

  • Processes of preparation, conduct, rehearse and debriefing
  • Selection of attendees
  • Scenario preparation
  • Mandates for decision making

10.30 - 10.45 Coffee Break

10.45 - 11.45 Agency Code of conduct (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

  • The Code of Conduct of agencies
  • Conflict of Interest
  • Transparency (EU), the Freedom of Information Act (USA)
  • Disclosure of data
  • Exchange of information with agencies

11.45 - 12.45 Regulatory intelligence and document management (Robert Schultz-Heienbrok, Xendo)

  • Regulatory intelligence and knowledge management
  • The Master Dossier
  • Data repository
  • Dossier compilation and submission
  • TIGes - e-submissions practilaties
  • The EU Telematics Strategy

12.45 - 13.30 Lunch

13.30 - 14.30 continued

14.30 - 14.45 Coffee break

14.45 - 16.15 Interaction of central project management with regulatory affairs (Gabriele Schricker, Wilex AG)

  • Goals of typical project managements
  • Tools
  • Types of time lines
  • Data collection
  • Interaction with external service providers

16.15 End of Day 1

16.15 Start of Sightseeing and Pre-Graduation Party of the fifth EUCRAF Course

Day 2: Friday, 09 October 2015

09.15 - 11.15 The regulatory affairs professional (Silvia Pfaff, Novartis)

  • Function and tasks
  • Skills
  • Performance

11.15 - 11.45 Coffee break

11.45 - 13.15 The Regulatory Professional at the interface (Kathy Hartmann-Campbell, Communication Training and Coaching)

  • Effective interpersonal communication
  • Intercultural communication
  • Collaborative communication

Good practices for virtual and global communication

13.15 - 14.15 Lunch

14.15 - 16.15 continued

16.15 - 16.45 Coffee break

16.45 - 18.45 Psychological aspects of project management (Violetta B. Kyburz, Fishawack Archimed AG, Basel/Zofingen)

18.45 End of Seminar 9

After 18.45 for Full Course students: rehearsal of agency meeting

For Full Course students:

Saturday, 10 October 2015

Agency Meeting with video recording and analysis

08.30 - 10.00 Preparation

10.00 - 10.30 Coffee Break

10.30 - 12.30 Agency Meeting

12.30 - 14.00 Lunch

14.00 - 17.30 Debriefing - Analysis of the performance at the agency meeting

17.30 End of Seminar 9 for Full Course students

Speaker

Kathy Hartmann-Campbell

Communication Coach

Kathy

Kathy Hartmann-Campbell was born and raised in the US and has lived in Basel for nearly 30 years. She graduated from Yale University with honors in philosophy and pursued a career in sales management and marketing before moving to Switzerland. After completing further training in applied psychology, and serving two and a half years as head of language training at Hoffmann-LaRoche, she started her own company in 1990 as a communication trainer and coach. She has worked locally and abroad with corporate clients such as Novartis, Syngenta, Roche, Ciba, IBM and the Bank for International Settlements, leading courses in all areas of communication skills and facilitating workshops and teambuilding sessions. As a public service to the expatriate community of Basel, she regularly offers workshops on understanding cultural differences. She has worked closely with regulatory affairs professionals to develop their communication effectiveness, conducting training programs in meeting management, presenting, negotiating, interpersonal and intercultural communication. In addition, she has prepared teams and conducted rehearsals for meetings with and presentations to regulatory authorities.

Topic lectured:

Seminar 9:

  • Effective interpersonal communication
  • Good practices for virtual communication
  • Content and delivery of presentation

Silvia Pfaff

Novartis Pharma AG

Silvia

Dr. Silvia Pfaff is Global Head Regulatory Excellence in Drug Regulatory Affairs at Novartis in Basle, Switzerland.

She joined Novartis in July 2007 as EU Regional Head for the Business Franchise Immunology and Infectious Diseases and then took on global responsibility as Global Therapeutic Area Lead for Immunology and Bone.

Prior to joining Novartis she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany.

She has got more than 20 years of regulatory experience in positions with increasing responsibility at Sanofi, Boehringer Mannheim, Knoll, Abbott and Novartis with a focus on biologics over the past 15 years.

She has a proven track record of successful submissions of global products in Europe, the US and Japan and achieving approvals with highly competitive labels.

Dr. Pfaff trained as pharmacist at the University of Heidelberg and earned her Ph.D from the Technical University in Munich.

Topic lectured:

Seminar 1:

  • Regulatory Institutions and other Stakeholders of the European System of Pharmaceuticals, their functions and role

Seminar 9:

  • The regulatory affairs´professional

Coaching Event: Agency meetings

  • Pre-submission meetings

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Gabriele Schricker

Morphosys AG, Munich

Gabriele

Dr. Gabriele Schricker is Director, Program Leader for proprietary drug development (biologics) in oncology and inflammatory diseases at Morphosys AG. She holds a PhD in Biology from the University of Cologne, Germany. After her PhD thesis in Zoology, she gained a second qualification in Scientific Information Management. Gabriele has a broad background of more than 16 years hands-on experience in international project management, information management and quality assurance in electronic document management. She started her career at a clinical CRO for 3 years and worked during the last 14 years for 6 biopharmaceutical companies in Germany, Switzerland and Italy. Furthermore, she is engaged in team development and personality coaching since more than 10 years and co-founder of “Kompetenz-Netzwerk für Coaching und Psychotherapie”.

Topic lectured:

Seminar 9:

  • Interaction of central project management with Regulatory Affairs

Robert Schultz-Heienbrok

Xendo Deutchland GmbH

Robert

Robert Schultz-Heienbrok has been educated in medical biology, followed by a PhD in protein biochemistry. He has completed a post-graduate program in Regulatory Affairs and has over 10 years of practical experience in the field. Working both with multinational pharmaceutical companies and small start-ups, Robert has gained broad experience with international submission procedures and dossier requirements for regulatory compliance as well as new market approvals. In 2009 he has been appointed Managing Director of Xendo Deutschland GmbH, a German subsidiary of the Dutch pharmaceutical service company Xendo B.V. His group focuses on regulatory affairs of marketed products, regulatory consultancy for biopharmaceutical developments and regulatory data management.

Topic lectured:

Seminar 9:

  • Regulatory intelligence and document management

Gertrud Thormann

The HST Consulting Network GmbH.

Gertrud

Dr. Gertrud Thormann-Huber is Partner and Principle Consultant of The HST Consulting Network GmbH. As an independent consultant she advises and assists many biopharmaceutical companies in the global development and regulatory strategies for successful approval of their recombinant proteins and/or monoclonal antibodies while often acting as a member of their global development teams or in the position of the Director Clinical & Regulatory Affairs. She has over 30 years experience with several pharmaceutical companies in all fields of drug development with a special emphasis on the development and regulatory issues of biotechnology-derived compounds and the interactions with the EMEA and FDA. Before setting-up her own consultancy firm in 1995 she has been 10 years with F. Hoffmann-La Roche in Basle where she has a track record of successful approvals of several submitted MAAs for recombinant proteins and in her last position she was a senior member of the global regulatory management team. Gertrud Thormann-Huber has a Degree in Pharmacy and PhD in Natural Sciences with specialization in pharmaceutical biology from University Munich.

Topic lectured:

Seminar 9:

  • Conducting effective meetings

Violetta B. Kyburz

Fishawack Archimed AG, Basel/Zofingen

Violetta

Violetta B. Kyburz has more than 30 years of experience in the pharmaceutical and biotech industry. She is a seasoned senior executive with in-depth knowledge in the areas of strategy, leadership, transformation, and project management. She is also experienced in due diligence processes, in the evaluation of innovative product ideas and business models.

Violetta holds a bachelor degree in business administration and a MAS diploma in Business Psychology. In addition, she has been trained at the Ashridge Business School and London Business School.

Topic lectured:

Seminar 9

  • Psyhological aspects of project management

Venue & Hotel

Venue and Hotel 2017

Munich, Germany.

Hotel details to be confirmed in due time.

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