EUCRAF is pleased to announce the names of the speakers of the 2nd annual EUCRAF Workshop on What currently matters for Biopharmaceuticals in Europe.

	Prof. Dr. Edward Geissler, Director of Experinmental Surgery, Department of Surgery, Regensburg University Medical Centre University Professor Geissler is a basic scientist with a primary interest in organ transplation research. He received his PhD (1991) and postoctoral training in Transplantation Immunology at the University of Wisconsin, Madison, Department of Surgery. Currently he is the Director of Experinmental Surgery at the University of Regensburg, Department of Surgery, where he has developed a range of interests. Professor Geissler remains engaged in Transplantation Immunology reserach, with the aim of contributing to the development of novel tolerance induction strategies. He is presently leading a recently established EU-FP7 international consortium aimed at applying cellular therapy to renal transplant recipients as a means of reducing allograft rejection. In addition, he has developed a strong focus in his research laboratories on the study of cancer in organ transplant recipients. In particular, he has studied mechanisms by which specific immunosuppressants may be used to diminish the increasingly recognised problem of cancer in transplant recipients. Here too he is bridging the gap between his research laboratories and the clinic by conducting an ongoing multinational clinical trial aimed at reducing hepatocellular carcinoma recurrence in liver transplant recipients. In 2008, he received "The Deutscher Krebspreis" for translational research in cancer from the German Cancer Society.
	Dr. Steffen Gross, Scientific Assessor and Laboratory Head, Section Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institut Dr. Steffen Gross is Deputy Head of the Section Monoclonal and Polyclonal Antibodies, Laboratory Head as well as Scientific Assessor at the Paul-Ehrlich Institute 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-Institute 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.
	Dr. Lois Hinmann, Drug Regulatory Affairs: Global Head, Early Development & Licensing, Novartis Pharmaceuticals Corporation Lois Hinman is Global Head of Early Development Regulatory Affairs, at Novartis Pharmaceuticals.  She is based in East Hanover, New Jersey and leads a global team of regulatory professionals who provide strategic regulatory input into programs in the Novartis portfolio from the time of candidate selection to proof-of-concept.  Lois has significant experience in biologics development over many years initially leading the research efforts to develop the first approved drug/antibody conjugate, Mylotarg, in the early 1990’s.  She is an internal expert in regulatory strategies for biologics at Novartis and is an active member of industry policy groups supporting initiatives on both personalized medicines and implementation of biosimilar pathways.  She was the PhRMA lead on the ICH E15 and E16 guidances on Pharmacogenomics and is a member of the BIO Biosimilars Implementation Team, the PhRMA Biosimilars Key Issue Team and the EBE Expert Group on Biosimilars.  Lois has over 20 years of experience in pharmaceutical R&D, with a focus on biologics programs and her career has included Discovery Research, Project Management, Business Development/Licensing as well as Regulatory Affairs.  Lois received her Ph.D. in biochemistry from Cornell University, with a minor in neuroscience, and is the author of numerous publications and abstracts.
	Dr. Anja Lageneckert, F. Hoffmann-La Roche Anja Langeneckert, PhD has been working as Group Leader of Early and Late Development at the International Regulatory Affairs department at F. Hoffmann-La Roche Ltd, Basel since November 2007. Before this appointment she was Global Regulatory Leader between April 2001 and October 2007 at Roche. From 1999 till 2001 she worked at the Roche Consumer Health, Vernier (Geneva) and Kaiseraugst at the Medical Information and Regulatory Affairs Unit. Her education is the following: Certification as a German Pharmacist (1996), PhD in Pharmacy, Pharmacokinetics, Johann-Wolfgang Goethe University, Frankfurt, Germany (1999) and TOPRA Diploma Regulatory Affairs (2007).
	Prof. Dr. Johannes Löwer, President IABS Johannes Löwer was born on November 20, 1944 in Vienna.  He studied medicine at the Universities of Würzburg and Tübingen from 1963-1969 and qualified as a physician in 1972 while pursuing studies in physiological chemistry and biochemistry from 1970-1974 at University of Tübingen. Dr. Löwer received a postdoctoral fellowship from Friedrich Miescher Laboratory at the Max Planck Society, Tübingen to pursue research in the field of RNA tumor viruses from 1976-1980. In 1981, Dr. Löwer joined the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Langen and headed the Cytology Section from 1982-1991 and the Division of Human Virology from 1987-2002. Dr. Löwer was appointed President of the Paul-Ehrlich-Institut on June 7, 2001. He retired from this position November 30. 2009. Dr.  Löwer holds the following degrees: Dr. med. [M.D.], the University of Tübingen, 1972; Qualification as physician, Stuttgart, 1974; Diplom-Biochemiker [M.Sc. in Biochemistry], the University of Tübin-gen, 1975; Venia legendi in Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1990: Professor of Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1999 Dr. Löwer’s former positions: President of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn, 2009-2010; Acting Director of the Federal  Institute for Drugs and Medical Devices (BfArM), Bonn, 2007-2009; President of the Paul-Ehrlich-Institut, Langen, 2001-2009; Acting Director of the Paul-Ehrlich-Institut, Langen, 1999-2001; Deputy Director of the Paul-Ehrlich-Institut, Langen, 1991-1999; Head of Human Virology Division, Paul-Ehrlich-Institut, Langen, 1987-2002; Head of Cytology Section, Human Virology Division, Paul-Ehrlich-Institut, Langen, 1982-1991; Scientist at the Paul-Ehrlich-Institut, Langen, 1981-1982; Postdoctoral fellowship at the Friedrich Miescher Laboratory of the Max Planck Society, Tübingen, 1976-1980
	Dr. Jan Müller-Berghaus, Clinical, Assessor, Paul-Ehrlich-Institut Dr. Jan Müller-Berghaus is currently working as clinical assessor of the 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.
	Dr. Gopalan Narayan, MHRA
	Dr. Silvia Pfaff, Drug Regulatory Affairs Head, Novartis Pharma AG Dr. Silvia Pfaff is Drug Regulatory Affairs Head for the Business Franchise Immunology and Infectious Diseases at Novartis in Basle, Switzerland. Prior to joining Novartis in July 2007 she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany. She has got almost 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.
	Dr. Monika Pietrek, Pietrek Associates Dr. Monika M. Pietrek is a medical doctor and epidemiologist. Having worked in clinical care, pharmaceutical and CRO industries and at a regulatory agency, she has a broad based experience in international health care with specific expertise in clinical development, drug safety and risk management. In addition, Dr. Pietrek has gained substantial knowledge in process design/analysis and quality management. During the past 20 years she has held senior positions at Behringwerke, the Paul-Ehrlich-Institute, Hoffmann-La Roche and PRA International, managing staff and projects across continents. Since 2009 Dr. Pietrek and colleagues provide their services to the pharmaceutical, biotechnology and medical device industry through Pietrek Associates GmbH, an independent consultancy firm. Dr. Pietrek has served as DIA volunteer for more than 17 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. At present she is a member of the Professional Education, Training and Development SIAC and the Editorial Board of the DIA Journal as well as of the programme committee of the Clinical Forum 2011. For more than 12 years Dr. Pietrek has been co-chairing a European PV expert group who focuses on operational aspects of drug safety and risk management. She has also been contributing to various initiatives led by ISPE, EFGCP, 7th MISG New Technology Forum and has been a regular speaker at international conferences.
	Dr. Ilona Reischl, AGES – Austrian Medicines and Medical Devices Agency AGES/PharmMed Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/PharmMed in March 2006, as Head of the Division in charge of Clinical Trial Assessment, now the Department for Clinical Trials, Preclinical and Statistical Evaluation in the Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management. She transitioned from practical research to the regulation of medicines at the US Food and Drug Administration (FDA) assessing the quality of biotech investigational new drug applications (INDs) and working on a research project on T cell signalling. Her initial training comprised a degree in pharmacy, a PhD in immunology/allergology and postdoctoral experience at an industrial research institute, the University of Southampton (UK) and the National Institutes of Health (USA). She is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies.
	Dr. Gabriele Schäffner-Dallmann, Study Director EUCRAF, Biopharmaceuticals Expert, Formerly PEI Dr. Gabriele Schäffner-Dallmann is an internationally renowned 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. Currently, Dr. Dallmann works as a consultant and is involved in development, strategic and market access projects. She is the founder of Pharmatching.com, an internet platform supporting outsourcing. 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 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. As biologist with a PhD in immunology from Berlin University, she is also visiting lecturer on biopharmaceuticals at Freiburg University..
	Dr. Christian Schneider, Senior Medical Officer, Danish Medicines Agency, formerly Paul-Ehrlich-Instiut Christian K Schneider, MD, is Senior Medical Officer at the Danish Medicines Agency. He is currently on a leave from the Paul-Ehrlich-Institute, the German Federal Agency for Sera and Vaccines, where he has been working as Director and Professor and Head of Division “EU Co-operation/Microbiology”. He is the chairman of the EMEA’s Committee for Advanced Therapies (CAT), which started its work in January 2009. Between 2007 and 2011 he was co-opted member of the CHMP, the Committee for Medicinal Products for Human Use at the European Medicines Agency EMEA, for the area of “Quality and safety (biological), with expertise in Advanced Therapies – Gene, Cell and Tissue Therapies”. He is chairman of the CHMP Working Party on Similar Biological Medicinal Products (BMWP) and was previously member of the CHMP Scientific Advice Working Party (SAWP). He has been actively involved in the drafting of several multidisciplinary guidelines, including the CHMP Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (the former “high-risk products guideline”), the CHMP Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues, and CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins for which he acts as Rapporteur. Before he joined the Paul-Ehrlich Institut, Christian K Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Department of Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiplesclerosis. During his clinical career, Christian K Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany.
	Dr. Marta Scwinger, Senior Regulatory Expert, Novartis Pharma AG Martina Schwinger is a biologist with in-depth knowledge of regulatory requirements and environment in China in theory and practice with focus on new project development and a good understanding of regulatory requirements in other regional countries, also with regards to biologics. She has been working at Novartis in different roles in the agrochemical industry in the field Human Resources. Since 2003 she is Regional Regulatory Manager in Regional DRA at Novartis Pharma. She is responsible for Lucentis, the top bio-product of Novartis Pharma in regional countries as well as for regulatory intelligence on China, Australia and South Korea.
	Dr. Jennifer Sims, Head Biologics Safety & Dispostion, Novartis Pharma AG Dr. Jennifer Sims is currently Head Biologics Safety & Dispostion, Translational Sciences, NIBR based in Basel, Switzerland. Dr. Sims has a Bachelor of Science degree, a PhD in Pharmacokinetics and Toxicology, and a Masters Certificate in Project Management. She has over 20 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 (Novartis and AstraZeneca), Dr. Sims 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. She is Vice Chair of the BioSafe leadership group and the EFPIA topic leader and Rapporteur for ICH S6 revision.
	Dr. Tetsuya Tanimoto, Cancer Institute,  Japanese Foundation for Cancer Research, Tokyo, Japan Tetsuya Tanimoto, M.D. has a broad experience in internal medicine with specific expertise in hematology/oncology, clinical drug development and evaluation with a current position as a medical reviewer for new drug application at the administrative office in Tokyo.  His brief medical experiences are as follows; he started his medical career in a general internal medicine at Kyushu University in Fukuoka in 1997. Due to his interest in clinical trial design and hematology/oncology, he joined the 3-year residency program at National Cancer Center Hospital in Tokyo.  Afterwards, he was employed as a staff physician of Hematology Division at Kyushu University Hospital and Matsuyama Red Cross Hospital in Shikoku, where he was involved in the wide range of patient care including hematopoietic stem cell transplantation.  During his subsequent academic career in Tottori University Hospital in Tottori, he assumed responsibilities as a ward chief as well as an assistant professor.  Since 2007 he has been assigned as a medical reviewer at Pharmaceutical and Medical Devices Agency (http://www.pmda.go.jp/english/index.html) in Tokyo and experienced a wide range of clinical trial protocols, drug and device development strategies and review of marketing authorization applications for various cancer drugs, antibiotics, vaccines, monoclonal antibodies, blood products and diagnostic tests as well as in regulatory actions due to efficacy/safety issues.  After 5-year experience at PMDA, he starts a new career at Japanese Foundation for Cancer Research, Navitas Clinic in Tokyo and works as a visiting physician in Fukushima. In addition he is looking for opportunities to launch a collaborative project between Japan and Shanghai, China.
	Dr. Gertrud Thormann,  The HST Consulting Network GmbH 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.
	Dr. Karen von Graevenitz Buser,  Senior Regulatory Program Manager, F. Hoffmann-La Roche Ltd. Karen v. Graevenitz is currently working as a Senior Regulatory Program Manager for Key Emerging Markets on metabolic compounds currently in clinical development. After finishing the Pharmacy School at the University of Basel (Switzerland), she worked for nearly 2 years in a Pharmacy before joining F. Hoffmann-La Roche Ltd. in Basel in 1989 as a Medical Manager in the Medical Marketing Department. She worked in several disease areas. She moved to regulatory affairs in 1999 as European partner on several projects in different therapeutic areas. She has extensive experience of the EU procedures and had several interactions with the CHMP members, EMA and its different working parties. Then, she took over an E7 Lead Role in 2009 and played a key role in developing regulatory strategies for metabolic compounds for Key Emerging Markets. Over the last 3 years, she was involved in several CDE Hearing Meetings in China.

Book  Seminar 4.1 (24-27 January) together with Seminar 4.2 (6-9 March) and receive 20% discount!

Seminar 4.1. Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier

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

Price: 2.752 EUR + 19%VAT for Industry and 1.824 EUR + 19%VAT for non-Industry, Government and Academic Institutions.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals, immunogenicity, biosimilars and the Module 4 and 5 requirements. Case studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab are also presented.

Speakers of Part II:

Dr. Roland Grobe-Einsler (formerly Bayer) and Dr. Simon Day from Roche are the Course Leaders of Seminar 4.2.

Dr. Bernd Müller-Beckmann (formerly Roche Penzberg) presents the principals of non-clinical development, the non-clinical CTD and explaines what special is in the non-clinical development of biopharmaceuticals.

Dr. Jennifer Sims, from Novartis, discusses the Tegenero case and its implications for the development of new biopharmaceuticals.

Dr. Paul Chamberlain from NDA Advisory Board gives a talk about immunogenicity and erythropoeitin.

Dr. Simon Day from Roche presents the principle of clinical development of biopharmaceuticals.

Dr. Ronald Grobe-Einsler (formerly Bayer) gives an insight to reserach to  early developmet: a clinical pharmacology perspective.

Dr. Simon Day and Dr. Gabriele Dallmann from EUCRAF introduces together a group workabout benefit-risk assessment for monoclonal antibodies.

Dr. Diane Seimetz from Fresenius Biotech holds a presentation: From scientific advice to successful marketing authorization - experience with the European authorization of the bispecific monoclonal antibody Removab.

Dr. Thomas Kirchlechner from Sandoz Biopharmaceuticals Development talks on regulatory principles of development of biosimilar medicinal products in the various regions: EU, FDA and WHO; global development, experience with submissions in different regions; experience with Sandoz biosimilars and current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars. He also presents a biosimilar case study.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier:sources and main characteristics of biopharmaceuticals; European CMC data requirements for the marketing authorization (Module3) and for the IMP; comparability; formulation development; isoform characterization and glycosylation; virus and TSE safety; stability of biopharmaceuticals; bioassay establishment and data presentation; new approaches in the manufacture - platform technologies and QbD; CMC data requirements in the USA and Japan and the special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals including biosimilars and the module 4 and 5 requirements and immunogenicity. Cases studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab will be presented.

Speakers of Part I:

Dr. Beatrix Metzner from MerckSerono and Prof. Jean-Yves Pabst from the University of Strasbourg are the Course Leaders of this seminar.

Dr. Andreas Bechthold from the University of Freiburg introduces sources and main characteristics of biopharmaceuticals.

Dr. Raffaella Balocco from WHO presents International Nonpropriatory Name (INN) of biopharmaceuticals.

Dr. Hannelore Wilkommen from Regulatory Affairs & Biologocal Safety Consulting discusses the safety of starting material of animal and / or human origin used in the process or formulation of the medicinal product.

Dr. Manuel Zahn from 3R Pharma Consulting gives an insight into the stability of biopharmaceuticals.

Dr. Michael Ausborn from Roche explains formulation and drug product manufacturing of biopharmaceuticals.

Dr. Hans-Joachim Wallny from Novartis speaks about bioassay.

Dr. Beatrix Metzner presents 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 and changes in process and their implications on the molecule, the comparibility excercise.

Dr. Fiona Greer from SGS M-Scan speaks on isoform, molecular subspecies characterisation and glycosylation.

Dr. Ole Schou (fromerly Novonordisk) introduces insulin as an example for use of individual manufacturing methods .

Dr. Pascal Wehrle from the University of Strasbourg presents ICH Q8: Introduction into the concept of Quality by Design and Design Space.

Book Seminar 3 (14-16 December) together with Seminar 4.1 (24-27 January) and Seminar 4.2 (6-9 March) in a package for a Special fee till 10 December!

Seminar 3.: Registration of Blood Products, Vaccines and ATMPs

Seminar 4.1. Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier

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

For more information see our Flyer. 

Photos and CVs of the speakers will be completed soon.

Prof. Dr. Andreas Bechthold from the University Freiburg and Dr. Gabriele Dallmann, from EUCRAF are the Course Leaders of this seminar.

Dr. Gabriele Dallmann gives a talk on the product class of blood products, speaks on the certification scheme on plasma master file (PMF) and provides information on plasma-derived products as a component of a medical device.

Dr. Christopher Bravery from CAB Ltd gives an overview on ATMPs including an introduction to the product, its regulation and related procedures. He also talks about the topic what is challenging in the development of ATMPs including examples of successfully authorised and failed products.

Dr. Michael Pfleiderer from PEI gives a presentation on the development and regulation of vaccines, the use of the antigen master file and the EMA pandemic influenza preparedness.

Dr. Jens Vollmar  from GSK talks about the industry perspective and the experience with the recent pandemic influenza. 

Dr Pfleiderer together with Dr. Vollmar present the famous example for a successful authorisation of a HPV vaccine Cervarix in a tandem talk.

Dr. Connie van Oers, Xendo is together with Dr. Gabriele Dallmann the Course Leader of this Seminar. She gives a talk on european national mutual recognition (MRP) and decentralised procedure (DCP).

Dunja Schumacher from NDA Regulatory Services presents the European Centralised Procedure at the European Medicines Agency (EMA).

Dr. Hartmut Krafft from PEI presents the Clinical Trial Application (CTA) in Europe.

Dr. Leyna Mulholland from Roche Pharma/Chugai Pharma speaks on the regulatory procedures relevant for submissions at the FDA and the Japanese Agency.

Dr. Tilo Netzer from Merck Serono presents the PDUFA process at FDA.

Dr. Gabriele Dallmann, EUCRAF, speaks on strategic considerations on selecting the authorisation procedure.

Esther Imboden from Regulix LTD discusses the particulars of regulatory processes in Switzerland.

Dr. Steffen Gross from the Paul-Ehrlich-Institut, Germany, presents how to submit variation applications and what are the critical requirements for variations valid for biopharmaceuticals in the EU.

Dr. Ruth Rettenmeier from Parexel Drug Development Consulting provides the critical aspects relevant for changes in the Summary of Product Characteristics (SmPC).

Dr. Karen van Graevenitz Buser from Roche gives an insight into the requirements valid for regulatory submissions in China.

Dr. Gertrud Thormann from The Hst Consulting Network GmbH is the Course Leader of Seminar 9.

Dr. Gabriele Dallmann from EUCRAF gives a talk on the Agency Code of Conduct. She speaks together with Dr. Gertrud Thormann how to conduct effective meetings.

Dr. Robert Schultz-Heienbrok from Xendo talks on regulatory intelligence and document management.

Dr. Gabriele Schricker from Wilex AG speaks on interaction of central project management with regulatory affairs.

Dr. Silvia Pfaff from Novartis gives a talk on the Regulatory Affairs`professional: function and tasks, skills, performance

Kathy Hartmann-Campbell, Communication Coach, provides the basics of effective interpersonal communication. She further speaks on good practices for virtual communication and gives a talk on the content and delivery of presentations.

EUCRAF is pleased to announce the names of the speakers of Seminar 1.

Dr. John Purves, Former EMA, and Dr. Geneviève Michaux from Covington and Burling LLP are the Course Leaders of Seminar 1.

Dr. Geneviève Micheaux and Dr. Gabriele Dallmann from EUCRAF give an introduction into the European regulatory system.

Dr. Geneviève Michaux gives also a talk on the European Pharmaceutical Legislation and the essential terms and provisions of the framework defining the marketing of pharmaceutical medicinal products in the EU/EEA

The topic "Orphan Medicinal Products in the EU/EEA" is presented by Dr. Rembert Elbers from BfArM.

Dr. Gabriele Dallmann, Former PEI, is the speaker for the topic “Legal particulars for biopharmaceuticals” which includes the regulations for Advanced Therapies and Biosimilars and the Plasma Master File.

Dr. Gesa Pellier, Dr. Judith Creba and Dr. Silvia Pfaff from Novartis speak on the regulatory institutions and other stakeholders of the European System of Pharmaceuticals, their functions and role.

The topic “The particular conditions applicable to Small and Medium Size Enterprises (SME) and the SME office of the EMEA” is presented by Dr. Juergen Regenold from Dr. Regenold GmbH.

Dr. Monika Eck-Schaupp from NDA Regulatory Service GmbH presents the details on the format and content of the marketing authorisation Application: The Common Technical Dossier (CTD) - Module 1. She also speaks on "Labelling, Package Leaflet and Summery of Product Characteristics (SmPC)" and on the Module 2 of the CTD. Further she gives a talk about the Risk Management Plan (RMP).

The principles of cooperation of international agencies and the activities of the International Conference on Harmonisation (ICH) are presented by Dr. Hoss Dowlat.

Another interesting topic is “General principles of registration and certification of medical device/drug combinations” which is presented by Dr. Anne Dupraz-Poiseau and Dr. Marielle Fournier from Voisin Consulting.

Dr. Stephane Andre from Roche is the Course Leader of Seminar 8.

Dr. Jaques Mascaro from Elan gives a talk on regulatory strategy.

Dr. Thomas Ecker from EPC Healthcare GmbH talks on HTA as a new element of the regulatory strategy - national requirements and European initiatives, reimbursement in Europe and considerations on how to design clinical development programmes to be used for approval and HTA.

Dr. Gabriele Dallmann from EUCRAF speaks on strategic considerations on interactions with regulatory agencies.

Dr. Jan Müller Berghaus from PEI gives a talk on interactions with regulatory agencies in the EU to receive scientific advice. Further he gives an insight into scientific advice from national competent authorities. Together with Dr. Stephane Andre from Roche he holds an interactive tandem session on the interactions of companies (represented by Dr. Stephanen Andre) and agencies (represented by Dr. Jan Müller-Berghaus) in the development of biopharmaceuticals.

Dr. Michelle Jessen from Micromet US speaks on interactions with FDA in the pre-IND process.

Dr. Boris Kreye from Bird & Bird talks on Pharmaceutical Intellectual Property (IP) strategy and practical considerations related to application and maintenance of patents in the EU.

Dr. Heike Wachenhausen from Lützeler Klümper Wachenhausen lawyers, formerly Novartis gives an insight into regulatory protection of medicinal products.

Dr. Susanne Heiland-Kunath from Takeda speaks on a cross-functional strategic forum to support decision-making for regulatory processes.

Dr. Michael Soldan from Biotest AG gives a talk on regulatory strategy for the introduction of changes in the manufacturing process.

Dr. Susanne Keitel from EDQM is the Course Leader of Seminar 7. She introduces the EDQM, the European Directorate for the Quality of Medicine and Healthcare, its role, structure, activities and certificate of suitabilty. Furtmeroe she speaks about Agency´s batch release, OMCL network, the Official Control Authority Batch release (OCABR) procedure and CAP testing. She also introduces PICS and WHO, their role, activities, WHO certificates and transatlantic simplification of administration procedures.  

Dr. Andrea Hauser from the University Hospital Regensburg, formerly Inspector RP bavaria discusses the questions: which quality management systems apply in the EU and how they are regulated and who is supervising the companies in the EU and in third countries and how this supervision is supervised. Moreover she gives a talk on the structure and role of the supervising authorities, especially the European Medicines Agency (EMA). Together with Dr. Gabriele Dallmann from EUCRAF she presents the topic: the Regulatory Affairs Department at the interphase. Furtmer she speaks about the principles of GMP, the company`s responsibilty in batch release and The Qualified person, the principles of GDP, the Rapid Alert System, product defects and recalls.

Dr. Wiebke Siegel a former Inspector at RP Darmstadt gives a talk on the special GMP considerations for biopharmaceuticals including advanced therapies.

Dr. Georges France from Pfizer gives an insight into the compliance and steady optimisation of production and processes.

Dr. Ralf Hess from PAREXEL gives a talk on the principles of GLP.

Dr. Bernd Raffelsberger from Pfizer speaks on the experience with inspections conducted by the different inspectorates from Europe, US and Japan and how an inspection is performed.

Dr. Dagmar Chase from Clinrex GmbH gives a talk on the principles of GCP, including the responsibilities of sponsors and investigators; serious GCP breaches and their impact on the amketing authorization and GCP inspections triggered during marketing authorization assessment.

Dr. Monika Pietrek from Pietrek Associates is the Course Leader of Seminar 6. She gives an introduction to the Pharmacovigilance concepts and specific aspects relevant to biologicals followed by a Case Study of erythropoetin. She further speaks on operational aspects including PV system today and in future, business processes, project management, quality oversight, safety governance models, safety relevant partner agreements, audits and inspections.

Dr. Christine Bendall from Arnold and Porter gives a talk on legal requirements and safety deliverables. She also speaks on the regulatory expectations and what is required at the time of authorization, what happens at post-authorisation. She also discusses the question: what will change with the new pharmacovigilance legislation.

Dr. Glyn Belcher, formerly Biogen Idec, works currently as Consultant gives a talk on the risk management approach. In a Case Study he discusses the topic: PML an acceptable or unacceptable risk? Implication of risk mitigation.

Dr. Angelika Joos from MSD and Dr. Genevieve Michaux from Covington & Burling LLP are the Course Leaders of Seminar 5.

Dr. Angelika Joos speaks on the EU Regulation No 1901/2006 on medicinal products for paediatric use as well as on the regulation for medicines in children in other regions with focus on the USA, implications of the EU legislation for the pharmaceutical industry:perspectives, challenges, opportunities and demonstrates a case illustrating PIP practice with discussion.

Dr. Daniel Brasseur, a PDCO Chair, Federal Agency for Medicines and Health Products, Belgium, holds a presentation about the EMA and the Paediatric Commitee (PDCO), the scope of the Paediatric Investigation Plan (PIP) and the list of paediatric needs and priority list of off-patent medicines. Further she gives an insight into the publication of clinical trial results and the development of regulatory guidelines on considerations of drug development in children.

Dr. Avril Mankel from NDA Regulatory Services explains the preparation of the Paediatric Investigation Plan (PIP).

Dr. Genevieve Michaeux gives a talk about PIP-related legal aspects.

Dr. Ashley Strougo from Astellas Pharma speaks about the considerations for developing and executing the PIP.

Dr. David M. Cross (formerly Pfizer Global Research and Development UK) presents the topic: Juvenile animal studies.

Dr. Jörg Breitkreutz from the University of Düsseldorf presents the requirements on paediatric drug formulations.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals, immunogenicity, biosimilars and the Module 4 and 5 requirements. Case studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab are also presented.

Speakers of Part II:

Dr. Roland Grobe-Einsler (formerly Bayer) and Dr. Simon Day from Roche are the Course Leaders of Seminar 4.2.

Dr. Bernd Müller-Beckmann (formerly Roche Penzberg) presents the principals of non-clinical development, the non-clinical CTD and explaines what special is in the non-clinical development of biopharmaceuticals.

Dr. Jennifer Sims, from Novartis, discusses the Tegenero case and its implications for the development of new biopharmaceuticals.

Dr. Paul Chamberlain from NDA Advisory Board gives a talk about immunogenicity and erythropoeitin.

Dr. Simon Day from Roche presents the principle of clinical development of biopharmaceuticals.

Dr. Ronald Grobe-Einsler (formerly Bayer) gives an insight to reserach to  early developmet: a clinical pharmacology perspective.

Dr. Simon Day and Dr. Gabriele Dallmann from EUCRAF introduces together a group workabout benefit-risk assessment for monoclonal antibodies.

Dr. Diane Seimetz from Fresenius Biotech holds a presentation: From scientific advice to successful marketing authorization - experience with the European authorization of the bispecific monoclonal antibody Removab.

Dr. Thomas Kirchlechner from Sandoz Biopharmaceuticals Development talks on regulatory principles of development of biosimilar medicinal products in the various regions: EU, FDA and WHO; global development, experience with submissions in different regions; experience with Sandoz biosimilars and current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars. He also presents a biosimilar case study.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier:sources and main characteristics of biopharmaceuticals; European CMC data requirements for the marketing authorization (Module3) and for the IMP; comparability; formulation development; isoform characterization and glycosylation; virus and TSE safety; stability of biopharmaceuticals; bioassay establishment and data presentation; new approaches in the manufacture - platform technologies and QbD; CMC data requirements in the USA and Japan and the special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals including biosimilars and the module 4 and 5 requirements and immunogenicity. Cases studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab will be presented.

Speakers of Part I:

Dr. Beatrix Metzner from MerckSerono and Prof. Jean-Yves Pabst from the University of Strasbourg are the Course Leaders of this seminar.

Dr. Andreas Bechthold from the University of Freiburg introduces sources and main characteristics of biopharmaceuticals.

Dr. Raffaella Balocco from WHO presents International Nonpropriatory Name (INN) of biopharmaceuticals.

Dr. Hannelore Wilkommen from Regulatory Affairs & Biologocal Safety Consulting discusses the safety of starting material of animal and / or human origin used in the process or formulation of the medicinal product.

Dr. Manuel Zahn from 3R Pharma Consulting gives an insight into the stability of biopharmaceuticals.

Dr. Michael Ausborn from Roche explains formulation and drug product manufacturing of biopharmaceuticals.

Dr. Hans-Joachim Wallny from Novartis speaks about bioassay.

Dr. Beatrix Metzner presents 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 and changes in process and their implications on the molecule, the comparibility excercise.

Dr. Fiona Greer from SGS M-Scan speaks on isoform, molecular subspecies characterisation and glycosylation.

Dr. Ole Schou (fromerly Novonordisk) introduces insulin as an example for use of individual manufacturing methods .

Dr. Pascal Wehrle from the University of Strasbourg presents ICH Q8: Introduction into the concept of Quality by Design and Design Space.

3-4 February 2011 - Freiburg im Br., Germany

Chair: Prof. Dr. Johannes Löwer

Day 1: Thursday, 03.02.2011

10.00-10.30: Registration coffee

Monoclonal antibodies as attractive targets for development

10.30-10.45: Welcome and introduction (Gabriele Schäffner-Dallmann, EUCRAF)

10.45-11.30: Monoconal antibodies in Europe - a historic review and future prospects (Gabriele Schäffner-Dallmann & Michael Reth, Max-Planck-Institut for Immunology Freiburg)

11.30-12.30: What is special with monoclonal antibodies? (Christian Schneider, PEI)

12.30-13.00: Questions and Answers

13.00-14.30: Lunch buffet

Experience in the regulatory process of biosimilars

14.30-15.15: Experience on already authorized biosimilars-approaches taken to justify the biosimilarity (Ann Johnsson, MPA)

15.15-16.00: Pioneering the development of biosimilars-lessons learnt and future challenges (Thomas Kirchlechner, Sandoz Biopharmaceuticals Development)

16.00-16.30: Coffee break

Update on upcoming biosimilar guidelines

16.30-17.15: Status update on the guideline on biosimilar monoclonal antibodies (Christian Schneider, PEI)

17.15-18.00: Update on WHO guideline (Martina Weise, BfArM)

18.00-19.00: Panel discussion (panelists are representatives of agencies and industry)

19.30: Networking dinner

Day 2: Friday, 04.02.2011

08.30-09.00: Welcome coffee

Key elements in development of a monoclonal antibody

09.00-09.45: Which attempts will be acceptable for a biosimilar monoclonal antibody-identical copy or altered manufacturing process? (Kowid Ho, AFSSAPS)

09.45-10.30: CMC: what can be characterized well, where are the limitations and what is especial for introduction of changes in next generation vs biosimilar monoclonal antibodies (Martin van der Plas, RIVM)

10.30-11.15: Preclinical development: what are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies (Karen de Smet, FAMHP)

11.15-12.00: Panel discussion (panelists are representatives of agencies and industry)

12.00-13.30: Lunch buffet

Clinical development

13.30-14.15: What are the challanges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies (Frank Scappaticci, Roche/Genentech Inc.)

14.15-15.00: Key clinical evidence-Key points to consider with regard to Surrogate endpoints-Immunogenicity-Extrapolation (Jan Müller-Berghaus, PEI)

15.00-16.00: Round tabel discussion with coffee served

16.00-16.30: Wrap up and concluding remark (Gabriele Schäffner-Dallmann)

EUCRAF is pleased to announce the names of the speakers of the 2nd annual EUCRAF Workshop on What currently matters for Biopharmaceuticals in Europe.

	Prof. Dr. Edward Geissler, Director of Experinmental Surgery, Department of Surgery, Regensburg University Medical Centre University Professor Geissler is a basic scientist with a primary interest in organ transplation research. He received his PhD (1991) and postoctoral training in Transplantation Immunology at the University of Wisconsin, Madison, Department of Surgery. Currently he is the Director of Experinmental Surgery at the University of Regensburg, Department of Surgery, where he has developed a range of interests. Professor Geissler remains engaged in Transplantation Immunology reserach, with the aim of contributing to the development of novel tolerance induction strategies. He is presently leading a recently established EU-FP7 international consortium aimed at applying cellular therapy to renal transplant recipients as a means of reducing allograft rejection. In addition, he has developed a strong focus in his research laboratories on the study of cancer in organ transplant recipients. In particular, he has studied mechanisms by which specific immunosuppressants may be used to diminish the increasingly recognised problem of cancer in transplant recipients. Here too he is bridging the gap between his research laboratories and the clinic by conducting an ongoing multinational clinical trial aimed at reducing hepatocellular carcinoma recurrence in liver transplant recipients. In 2008, he received "The Deutscher Krebspreis" for translational research in cancer from the German Cancer Society.
	Dr. Steffen Gross, Scientific Assessor and Laboratory Head, Section Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institut Dr. Steffen Gross is Deputy 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-Institute 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.
	Dr. Lois Hinmann, Drug Regulatory Affairs: Global Head, Early Development & Licensing, Novartis Pharmaceuticals Corporation Lois Hinman is Global Head of Early Development Regulatory Affairs, at Novartis Pharmaceuticals.  She is based in East Hanover, New Jersey and leads a global team of regulatory professionals who provide strategic regulatory input into programs in the Novartis portfolio from the time of candidate selection to proof-of-concept.  Lois has significant experience in biologics development over many years initially leading the research efforts to develop the first approved drug/antibody conjugate, Mylotarg, in the early 1990’s.  She is an internal expert in regulatory strategies for biologics at Novartis and is an active member of industry policy groups supporting initiatives on both personalized medicines and implementation of biosimilar pathways.  She was the PhRMA lead on the ICH E15 and E16 guidances on Pharmacogenomics and is a member of the BIO Biosimilars Implementation Team, the PhRMA Biosimilars Key Issue Team and the EBE Expert Group on Biosimilars.  Lois has over 20 years of experience in pharmaceutical R&D, with a focus on biologics programs and her career has included Discovery Research, Project Management, Business Development/Licensing as well as Regulatory Affairs.  Lois received her Ph.D. in biochemistry from Cornell University, with a minor in neuroscience, and is the author of numerous publications and abstracts.
	Dr. Anja Lageneckert, F. Hoffmann-La Roche Anja Langeneckert, PhD has been working as Group Leader of Early and Late Development at the International Regulatory Affairs department at F. Hoffmann-La Roche Ltd, Basel since November 2007. Before this appointment she was Global Regulatory Leader between April 2001 and October 2007 at Roche. From 1999 till 2001 she worked at the Roche Consumer Health, Vernier (Geneva) and Kaiseraugst at the Medical Information and Regulatory Affairs Unit. Her education is the following: Certification as a German Pharmacist (1996), PhD in Pharmacy, Pharmacokinetics, Johann-Wolfgang Goethe University, Frankfurt, Germany (1999) and TOPRA Diploma Regulatory Affairs (2007).
	Prof. Dr. Johannes Löwer, President IABS Johannes Löwer was born on November 20, 1944 in Vienna.  He studied medicine at the Universities of Würzburg and Tübingen from 1963-1969 and qualified as a physician in 1972 while pursuing studies in physiological chemistry and biochemistry from 1970-1974 at University of Tübingen. Dr. Löwer received a postdoctoral fellowship from Friedrich Miescher Laboratory at the Max Planck Society, Tübingen to pursue research in the field of RNA tumor viruses from 1976-1980. In 1981, Dr. Löwer joined the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Langen and headed the Cytology Section from 1982-1991 and the Division of Human Virology from 1987-2002. Dr. Löwer was appointed President of the Paul-Ehrlich-Institut on June 7, 2001. He retired from this position 30. November 2009. Dr.  Löwer holds the following degrees: Dr. med. [M.D.], the University of Tübingen, 1972; Qualification as physician, Stuttgart, 1974; Diplom-Biochemiker [M.Sc. in Biochemistry], the University of Tübin-gen, 1975; Venia legendi in Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1990: Professor of Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1999 Dr. Löwer’s former positions: President of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn, 2009-2010; Acting Director of the Federal  Institute for Drugs and Medical Devices (BfArM), Bonn, 2007-2009; President of the Paul-Ehrlich-Institut, Langen, 2001-2009; Acting Director of the Paul-Ehrlich-Institut, Langen, 1999-2001; Deputy Director of the Paul-Ehrlich-Institut, Langen, 1991-1999; Head of Human Virology Division, Paul-Ehrlich-Institut, Langen, 1987-2002; Head of Cytology Section, Human Virology Division, Paul-Ehrlich-Institut, Langen, 1982-1991; Scientist at the Paul-Ehrlich-Institut, Langen, 1981-1982; Postdoctoral fellowship at the Friedrich Miescher Laboratory of the Max Planck Society, Tübingen, 1976-1980
	Dr. Jan Müller-Berghaus, Clinical Assessor, Head of Section Mono and Polyclonocal Antibodies, Paul-Ehrlich-Institut Dr. Jan Müller-Berghaus is currently working as clinical assessor of the 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.
	Dr. Gopalan Narayan, MHRA Gopalan  Narayanan, MD, FRCP, FFPM has been currently  working as Expert Medical Assessor at the Biologicals Unit, Licensing Division, Medicines and Healthcare products Regulatory Agency in London, UK since 2001. His previous appointments include: Associate Director, Clinical Development, Chiron Corporation, USA; Medical Advisor, Medical Affairs, Reckitt & Colman Pharmaceuticals, Hull, Yorkshire, UK.            His Clinical appointments are:  general internal medicine/ gastroenterology His professional qualifications are the followings:  MBBS; MD (Madras, India); MRCP (UK); FRCP (UK); Fellow of the Faculty of Pharmaceutical Medicine (UK). He is member of Committee for Advanced Therapies/ EMA, Scientific Advice Working Party/CHMP, furthermore he is chair of Regulatory Special Interest Network, Faculty of Pharmaceutical Medicine, The Royal College of Physicians, UK. His previous memberships are: Biosimilar Medicines Working Party CHMP/BMWP, EMA; Gene Therapy Working Party, EMA Publications: on Assessing the Safety of Stem Cell Therapeutics (Cell Stem cell; June, 2011), Gene therapy regulatory requirements (Bundesgesundheitsbl 2010 • 53:30–37) ; Advanced Therapy Medicinal Products (Nature Reviews Drug discovery March, 2010) and Scientific Advice in Europe (Pharmaceutical Physician; July, 2010)
	Dr. Silvia Pfaff, Drug Regulatory Affairs Head, Novartis Pharma AG Dr. Silvia Pfaff is Drug Regulatory Affairs Head for the Business Franchise Immunology and Infectious Diseases at Novartis in Basle, Switzerland. Prior to joining Novartis in July 2007 she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany. She has got almost 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.
	Dr. Monika Pietrek, Pietrek Associates Dr. Monika M. Pietrek is a medical doctor and epidemiologist. Having worked in clinical care, pharmaceutical and CRO industries and at a regulatory agency, she has a broad based experience in international health care with specific expertise in clinical development, drug safety and risk management. In addition, Dr. Pietrek has gained substantial knowledge in process design/analysis and quality management. During the past 20 years she has held senior positions at Behringwerke, the Paul-Ehrlich-Institut, Hoffmann-La Roche and PRA International, managing staff and projects across continents. Since 2009 Dr. Pietrek and colleagues provide their services to the pharmaceutical, biotechnology and medical device industry through Pietrek Associates GmbH, an independent consultancy firm. Dr. Pietrek has served as DIA volunteer for more than 17 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. At present she is a member of the Professional Education, Training and Development SIAC and the Editorial Board of the DIA Journal as well as of the programme committee of the Clinical Forum 2011. For more than 12 years Dr. Pietrek has been co-chairing a European PV expert group who focuses on operational aspects of drug safety and risk management. She has also been contributing to various initiatives led by ISPE, EFGCP, 7th MISG New Technology Forum and has been a regular speaker at international conferences.
	Dr. Ilona Reischl, AGES – Austrian Medicines and Medical Devices Agency AGES/PharmMed Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/PharmMed in March 2006, as Head of the Division in charge of Clinical Trial Assessment, now the Department for Clinical Trials, Preclinical and Statistical Evaluation in the Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management. She transitioned from practical research to the regulation of medicines at the US Food and Drug Administration (FDA) assessing the quality of biotech investigational new drug applications (INDs) and working on a research project on T cell signalling. Her initial training comprised a degree in pharmacy, a PhD in immunology/allergology and postdoctoral experience at an industrial research institute, the University of Southampton (UK) and the National Institutes of Health (USA). She is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies.
	Dr. Gabriele Schäffner-Dallmann, Study Director EUCRAF, Biopharmaceuticals Expert, Formerly PEI Dr. Gabriele Schäffner-Dallmann is an internationally renowned 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. Currently, Dr. Dallmann works as a consultant and is involved in development, strategic and market access projects. She is the founder of Pharmatching.com, an internet platform supporting outsourcing. 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 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. As biologist with a PhD in immunology from Berlin University, she is also visiting lecturer on biopharmaceuticals at Freiburg University..
	Dr. Christian Schneider, Senior Medical Officer, Danish Medicines Agency, formerly Paul-Ehrlich-Instiut Christian K. Schneider, MD, is Senior Medical Officer at the Danish Medicines Agency. He is currently on a leave from the Paul-Ehrlich-Institut, the German Federal Agency for Sera and Vaccines, where he has been working as Director and Professor and Head of Division “EU Co-operation/Microbiology”. He is the chairman of the EMA’s Committee for Advanced Therapies (CAT), which started its work in January 2009. Between 2007 and 2011 he was co-opted member of the CHMP, the Committee for Medicinal Products for Human Use at the European Medicines Agency EMA, for the area of “Quality and safety (biological), with expertise in Advanced Therapies – Gene, Cell and Tissue Therapies”. He is chairman of the CHMP Working Party on Similar Biological Medicinal Products (BMWP) and was previously member of the CHMP Scientific Advice Working Party (SAWP). He has been actively involved in the drafting of several multidisciplinary guidelines, including the CHMP Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (the former “high-risk products guideline”), the CHMP Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues, and CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins for which he acts as Rapporteur. Before he joined the Paul-Ehrlich Institut, Christian K. Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Department of Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiplesclerosis. During his clinical career, Christian K. Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany.
	Dr. Marta Scwinger, Senior Regulatory Expert, Novartis Pharma AG Martina Schwinger is a biologist with in-depth knowledge of regulatory requirements and environment in China in theory and practice with focus on new project development and a good understanding of regulatory requirements in other regional countries, also with regards to biologics. She has been working at Novartis in different roles in the agrochemical industry in the field Human Resources. Since 2003 she is Regional Regulatory Manager in Regional DRA at Novartis Pharma. She is responsible for Lucentis, the top bio-product of Novartis Pharma in regional countries as well as for regulatory intelligence on China, Australia and South Korea.
	Dr. Jennifer Sims, Head Biologics Safety & Dispostion, Novartis Pharma AG Dr. Jennifer Sims is currently Head Biologics Safety & Dispostion, Translational Sciences, NIBR based in Basel, Switzerland. Dr. Sims has a Bachelor of Science degree, a PhD in Pharmacokinetics and Toxicology, and a Masters Certificate in Project Management. She has over 20 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 (Novartis and AstraZeneca), Dr. Sims 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. She is Vice Chair of the BioSafe leadership group and the EFPIA topic leader and Rapporteur for ICH S6 revision.
	Dr. Tetsuya Tanimoto, Cancer Institute,  Japanese Foundation for Cancer Research, Tokyo, Japan Tetsuya Tanimoto, M.D. has a broad experience in internal medicine with specific expertise in hematology/oncology, clinical drug development and evaluation with a current position as a medical reviewer for new drug application at the administrative office in Tokyo.  His brief medical experiences are as follows: he started his medical career in a general internal medicine at Kyushu University in Fukuoka in 1997. Due to his interest in clinical trial design and hematology/oncology, he joined the 3-year residency program at National Cancer Center Hospital in Tokyo.  Afterwards, he was employed as a staff physician of Hematology Division at Kyushu University Hospital and Matsuyama Red Cross Hospital in Shikoku, where he was involved in the wide range of patient care including hematopoietic stem cell transplantation.  During his subsequent academic career in Tottori University Hospital in Tottori, he assumed responsibilities as a ward chief as well as an assistant professor.  Since 2007 he has been assigned as a medical reviewer at Pharmaceutical and Medical Devices Agency (http://www.pmda.go.jp/english/index.html) in Tokyo and experienced a wide range of clinical trial protocols, drug and device development strategies and review of marketing authorization applications for various cancer drugs, antibiotics, vaccines, monoclonal antibodies, blood products and diagnostic tests as well as in regulatory actions due to efficacy/safety issues.  After 5-year experience at PMDA, he starts a new career at Japanese Foundation for Cancer Research, Navitas Clinic in Tokyo and works as a visiting physician in Fukushima. In addition he is looking for opportunities to launch a collaborative project between Japan and Shanghai, China.
	Dr. Gertrud Thormann,  The HST Consulting Network GmbH 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.
	Dr. Karen von Graevenitz Buser,  Senior Regulatory Program Manager, F. Hoffmann-La Roche Ltd. Karen v. Graevenitz is currently working as a Senior Regulatory Program Manager for Key Emerging Markets on metabolic compounds currently in clinical development. After finishing the Pharmacy School at the University of Basel (Switzerland), she worked for nearly 2 years in a Pharmacy before joining F. Hoffmann-La Roche Ltd. in Basel in 1989 as a Medical Manager in the Medical Marketing Department. She worked in several disease areas. She moved to regulatory affairs in 1999 as European partner on several projects in different therapeutic areas. She has extensive experience of the EU procedures and had several interactions with the CHMP members, EMA and its different working parties. Then, she took over an E7 Lead Role in 2009 and played a key role in developing regulatory strategies for metabolic compounds for Key Emerging Markets. Over the last 3 years, she was involved in several CDE Hearing Meetings in China.

Dr. Gabriele Schäffner-Dallmann, EUCRAF, is the Course Leader of this Seminar.

Dunja Schumacher from NDA Regulatory Science Ltd., presents the European Centralised Procedure at the European Medicines Agency (EMA).

Anna Somuyiwa from Segulah Consulting Ltd. presents the details of the European Mutual recognition (MRP) and Decentralised procedure (DCP).

Dr. Leyna Mulholland from Roche Pharma/Chugai Pharma speaks on the regulatory procedures relevant for submissions at the FDA and the Japanese Agency.

Esther Imboden from Regulix LTD discusses the particulars of regulatory processes in Switzerland.

Dr. Martina Schwinger from Novartis Pharma gives an insight into the requirements valid for regulatory submissions in China.

Dr. Steffen Gross from the Paul-Ehrlich-Institut, Germany, presents how to submit variation applications and what are the critical requirements for variations valid for biopharmaceuticals in the EU.

Dr. Ruth Rettenmeier from Parexel Drug Development Consulting provides the critical aspects relevant for changes in the Summary of Product Characteristics (SmPC).

Dr. Hartmut Krafft presents the procedures valid for the authorisation of clinical trial applications in Europe.

Next generation and biosimilar monoclonal antibodies – essential considerations towards regulatory acceptance in Europe

Date: 03 - 04 February 2011

Location: Freiburg i. Breisgau

This workshop has been initiated to provide a platform where regulators, scientists, regulatory affairs professionals, manufacturers and service providers meet, exchange knowledge and views related to the development of monoclonal antibodies, regardless whether they are newly developed, next generation (or follow-up) or biosimilars.

Innovation is introduced by manifold options i.e. through development of new monoclonal antibodies for new indications, by reducing the dose frequency for authorized products or by introducing a new route of administration allowing self-administration.

On the other hand, development of biosimilar monoclonal antibodies has the potential in reducing the health care costs.

Extensive experience has been accumulated in the manufacture and testing approaches utilized in the development of monoclonal antibodies.

The processes to establish productive clones, to manufacture at higher yields, to humanize antibodies on one hand and the test methods to characterize these molecules on the other hand have been evolved tremendously. The available instrumentation more and more provides confidence that the products may be well characterized. However, despite all of these achievements a monoclonal antibody remains a complex construct which is not fully understood as to how specificity, function and structure relate to their clinical mode of action, efficacy and safety.

Other than in the treatment with erythropoietin, growth hormones or G-CSF, monoclonal antibodies are not used to replace or substitute proteins which are naturally occurring but lacking in the individual patient. Monoclonal antibodies instead introduce new pharmacological principles in large indications requiring investigation in conventional large pivotal trials. Each individual antibody is considered an individual molecule for which proof of efficacy and safety is required in this indication based on pivotal endpoints and for the dose claimed.

Consequently, critical questions regularly arising include:

Acceleration of development of monoclonal antibodies is in the interest of all involved stakeholders. However, care needs to be taken to ensure that acceleration does not lead to overlooking potential risks.

This workshop was chaired by Prof. Johannes Löwer and and aimed at the exchange on the common understanding of scientific and regulatory requirements as a prerequisite of successful antibody development.

PROGRAMME OF THE WORKSHOP

Day 1. Thursday, 03. February2011

Session 1: Monoclonal antibodies as attractive targets for development

10.30 - 10.45  Prof. Dr. Johannes Löwer: Welcome and introduction
10.45 - 11.30  Michael Reth, Max-Planck-Institut for Immunology, Freiburg, and Gabriele Schäffner-Dallmann, EUCRAF: Monoclonal antibodies in Europe - a historic review and future prospects
11.30 - 12:30  Christian Schneider, PEI: What is special with monoclonal antibodies?
12:30 - 13:00  Q&A
13:00 - 14:30  Lunch

Session 2: Experience in the regulatory process of biosimilars

14:30-15:15   Ann Johnsson, MPA: Experience on already authorized biosimilars – approaches taken to justify the biosimilarity
15:15-16:00  Thomas Kirchlechner, Sandoz Biopharmaceuticals Development: Pioneering the development of biosimilars - lessons learnt and future challenges
16:00-16:30   Coffee break

Session 3: update on upcoming biosimilar guidelines

16:30-17:15   Christian Schneider, PEI: Status update on the guideline on biosimilar monoclonal antibodies
17:15-18:00   Martina Weise, BfArM: Update on WHO guideline
18:00-19:00  Panel discussion with Ann Johnsson, Thomas Kirchlechner, John Purves, Janice Reichert, Christian Schneider, Thomas Schreitmüller and Martina Weise
19:30             Networking Dinner

Day 2. Friday, 04. February2011

Session 4: Key elements in development of a monoclonal antibody

09:00-09:45  Kowid Ho, AFSSAPS: Which attempts will be acceptable for a biosimilar monoclonal antibody - identical copy or altered manufacturing process?
09:45-10:30  Martin van der Plas, RIVM, The Netherlands:
CMC: what can be characterized well, where are the limitations and what is especial for introduction of changes in next generation vs biosimilar monoclonal antibodies
10:30-11:15  Karen de Smet, FAMHP Belgium:
Preclinical development: what are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies
11:15-12:00  Panel discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas
12.00-13.30   Lunch

Session 5: Clinical development

13:30-14:15  Frank Scappaticci Roche/Genentech Inc.: What are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies
14:15-15:00   Jan Müller-Berghaus, PEI: Key clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation
15:00-15:20   Coffee break
15:20-16:00  Round table discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas
16:00             Gabriele Schäffner-Dallmann: Wrap up and concluding remark
16:30             End of the workshop

SPEAKERS OF THE WORKSHOP

The workshop provided insight into why monoclonal antibodies were attractive targets for development and what the key elements in development of a monoclonal antibody were. All speakers of the workshop are experts in the field and were involved in the development of monoclonal antibodies or biosimilar products or in the assessment of related regulatory submissions.

Gabriele Schäffner-Dallmann, EUCRAF/Pharmatching GmbH and Michael Reth, Max-Planck-Institut for Immunology Freiburg, provided a historic review and future prospects of monoclonal antibodies in Europe. Christian Schneider, PEI, Germany, discussed what was special with monoclonal antibodies. Ann Johnsson, MPA, Sweden, reviewed the experience on already authorized biosimilars and the approaches taken to justify biosimilarity. Thomas Kirchlechner, Sandoz, reflected the experience and challenges in development of biosimilars. Christian Schneider gave an update on the status of the guideline on biosimilar monoclonal antibodies and Martina Weise, BfArM, Germany, gave an update on the relevant WHO guideline.

Kowid Ho, AFSSAPS, France, presented the attempts being considered acceptable for a biosimilar monoclonal antibody, whether it had to be an identical copy or whether an altered manufacturing process might be acceptable. Martin van der Plas, RIVM, The Netherlands, discussed the CMC requirements and what could be characterized well, where were the limitations and what was special for introduction of changes in next generation vs biosimilar monoclonal antibodies. Karen de Smet, FAMHP, Belgium, gave an introduction into the requirements of preclinical development, what were the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies.

Frank Scappaticci, Roche/Genentech Inc., UK discussed the challenges in the development of a new monoclonal antibody and what needed to be considered for next generation and biosimilar monoclonal antibodies. For the clinical development, Jan Müller-Berghaus, PEI , Germany, discussed the key elements of clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation.

Participants could get a further insight into the current state of the art considerations during the panel discussions with representatives of agencies and industry and a networking dinner offers excellent opportunities to further exchange your views on the matter.

If you are interested - you can start the course at any time. Or you can book individual Seminars according to your needs.
Further details see here