Programme
Speakers
Distinguished speakers from Health Authorities, from University Freiburg, from University Strasbourg, from the European Directorate for the Quality of Medicines (EDQM) and from global and local pharmaceutical and biotechnology companies support the course by their contribution. They are internationally renowned experts providing distinctive expertise to the course participants.
The presentations impart relevant basic and specific knowledge, case studies are presented and discussed and interactive presentations allow the attendees to comment and discuss. By this the course is very lively, the participants benefit from the exchange between the group and the speakers. Presentation techniques are also trained among the participants as the results of the group work on case studies or home work are presented as part of the course.
In the following overview the speakers of the course are presented with their specific background and the topics they present in the course.
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Dr. Stephane Andre, F. Hoffmann - La Roche Dr. Stephane Andre is Head of EU/ROW Regulatory Affairs of the Hoffmann - La Roche and Genentech integrated company in Basel as well as core member of the Drug Safety Committee. He has been working in the field of regulatory affairs since 17 years up to now. From 1995 to 1999 he was Associate Director in International Regulatory Affairs Liaison, Oncology, Anti-infectives, anti HIV drugs and Director and Head of the Corporate Regulatory Affairs Oncology Liaison Europe at Rhone-Poulenc Rorer. He was Vice President of WYETH Pharmaceuticals in USA from 2000 to 2007 and responsible for different fields, including Womens` Health and Clinical Trial Application. Since 2007 he worked as Site Head of Pharma Drug Regulatory at Hoffmann - La Roche and since 2009 he has been working as Head of the EU/ROW Regulatory Affairs for that company. He is responsible for the Basel regulatory teams, the collaboration with Chugai as well as the Welwyn site Regulatory teams to the EU team of Regularity professionals reporting to Basel team. Topics lectured Seminar 8:
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Dr. Michael Ausborn, F. Hoffmann – La Roche Dr. Michael Ausborn is currently working for the Global Head Formulation Research pRED at F. Hoffmann – La Roche Ltd. Once absolved his PhD in Pharmacy he worked as PostDoc at the University of Florida. After several positions in the field of Drug Delivery in Germany and Switzerland he moved again to the USA and worked for the Novartis Center for Cell and Gene Therapy. From the year 2000 to 2004 Dr. Ausborn worked as Group Head Pharmaceutical Development Parenteral & Topical Dosage Forms, TR&D at Novartis Pharma AG in Basel. 2005 he became Head of the Pharmaceutical & Analytical Research & Development at F.Hoffmann-La Roche Ltd, Basel where he is still working in another position. Topics lectured Seminar 4.1:
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Dr. Matthew Baker, Antitope Ltd. Dr. Baker is a founder and the Chief Scientific Officer of Antitope Ltd, a Cambridge (UK) based company which specializes in assessing and reducing the immunogenic potential of biologics. He has held senior management positions at a number of companies including Biovation (subsidiary of Merck KGaA), CTL Ltd and Whatman BioSciences. As an academic researcher Dr. Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK after obtaining his PhD in cellular immunology at University of Birmingham, UK. Topics lectured Immunogenicity Integrated - Interactive Workshop
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Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology. She worked at the "Mario Negri Institute for Pharmacological Researches in Milan before joining WHO in 1992. From 1992 to 2001 she worked in the regulatory support Unit within WHO and travelled all around the world in particular in EMRO (Eastern Mediterranean Region) and AFRO (Africa) Countries. Since 2001 she is the Manager of the International Nonproprietary Names Programme in the Department of Essential Medicines and Pharmaceutical Policies. Topics lectured Seminar 4.1:
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Prof. Dr. Andreas Bechthold, University of Freiburg Prof. Dr. Andreas Bechthold has been working in the field of pharmaceutical biotechnology since more than 20 years. As postdoc he worked in Seattle, USA and in Kyoto, Japan. After his habilitation in 2000 he moved to Kiel and in 2001 he became Head of Pharmaceutical Biology and Biotechnology in Freiburg. He is cofounder of Combinature-Biopharm AG, a biotech company located in Berlin. The last three years he was Dean of the Faculty for Chemistry, Pharmacy and Earth Science. Andreas Bechthold is pharmacist with a Ph.D. in pharmaceutical biology from the Bonn University. Topics lectured Seminar 4.1:
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Dr. Glyn Belcher, Consultant (formerly Biogen Idec)
Dr. Glyn Belcher has over 25 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 and a global safety officer of Takeda headquarters in Osaka. 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. Topics lectured Seminar 6:
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Dr. Christine Bendall, Consultant, Arnold & Porter Christine Bendall qualified as a solicitor in England and Wales in 1985 and specialises in the regulation of pharmaceuticals in the EU with an emphasis on clinical research and drug safety. She works as a consultant on these issues and has worked (on secondment) for MCA in the UK (now MHRA) and in private legal practice. She also lectures 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” (4th Edition; Edited by Stephens, Talbot and Routledge; 5th edition due to be published in 2012). Topics lectured Seminar 6:
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Dr. Christopher Bravery, Consultant, CAB Ltd. Christopher Bravery founded CAB Ltd. at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has spent most of his career working in regenerative medicine: starting with a PhD in xenotranplantation immunology he first moved into industry in 1998 when he joined Imutran Ltd (A Novartis Pharma AG Co.) developing novel transgenic pigs to treat human organ failure. Following the closure of Imutran, Christopher moved to Intercytex and subsequently made the transition to regulatory affairs by joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines. Topics lectured Seminar 3:
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Prof. Dr. Daniel Brasseur, General Directorate Medicine of the Federal Ministry of Public Health of Belgium Professor Daniel Brasseur is Head of the Medical Assessors at the General Directorate Medicine of the Federal Ministry of Public Health of Belgium. He received his Ph D in Paediatrics in 1986 at the Free University of Brussels where he acted is physician since 1976 at the University Children’s’ Hospital, Queen Fabiola in Brussels. Topics lectured Seminar 5:
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Prof. Dr. Jörg Breitkreutz, Heinrich-Heine-University Düsseldorf 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. Topics lectured Seminar 5:
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Dr. Monika Chabicovsky, MC Toxicology Consulting Dr. Monika Chabicovsky is an independent consultant for drug development and regulatory affairs. She trained in experimental cancer research and toxicology at the Medical University of Vienna, the University of Cardiff and the University of Innsbruck. She holds a PhD in cancer research, a master in toxicology and a diploma in regulatory affairs. She is a EUROTOX registered toxicologist, author of several scientific publications in peer-reviewed journals and holds international patents. Previously she was with Austrian and US biotech companies, where she was responsible for regulatory affairs and toxicology. Since 2005 she works with Granzer Regulatory Consulting & Services as a Senior Consultant in Munich. In 2006 she founded MC Toxicology Consulting, with its core business focused on the nonclinical development of biologics, small molecules, vaccines and advanced therapy medicinal products. Dr. Chabicovsky has signed responsible or contributed significantly to drug development programs and Marketing Authorisation Applications of numerous drugs in Europe, USA & Canada. Topics lectured Seminar 4.2:
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Dr. Paul Chamberlain, NDA Advisory Board Paul Chamberlain is a biopharmaceutical product development specialist, with particular interest in development of therapeutic monoclonal antibody-based products. 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 duediligence 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 (www.ndareg.com), 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. Topics lectured Seminar 4.2:
Immunogenicity Integrated - Interactive Workshop:
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Dr. Dagmar Chase, Clinrex Ltd. 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). Topics lectured Seminar 7:
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Graham Cook’s current position in Pfizer’s Global Quality Organization is Senior Director, Process Knowledge/Quality by Design. He is a member of Pfizer’s QbD Council and was a moderator at the ICH IWG’s Integrated Implementation Training Workshop for ICH Q8, Q9 & Q10 in Tallinn, Estonia, in June 2010. He holds Pfizer’s vote in the ASTM International E55 committee which is developing consensus standards for QbD/PAT in pharmaceutical manufacturing. Graham is involved in several EFPIA QbD/PAT initiatives, and is a member of the control strategy team in the ISPE PQLI initiative. Graham is a member of the British Pharmacopoeia Commission. He is a registered pharmacist and completed his Ph.D. in pharmaceutics at the School of Pharmacy in London. Previous roles include Technology Director for Wyeth’s European External Supply and Formulation Director for Wyeth Consumer Healthcare in Richmond, Virginia, and he has also worked for Reckitt & Colman in formulation development and programme management, and in formulation development for Beecham Pharmaceuticals. Topics lectured Seminar 7:
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Dr. Judith Creba, Novartis Pharma AG Judith Creba has a PhD in Biochemistry from Birmingham University in the UK and spent 5 years working in Research in the Pharma Industry in the areas of Neuroscience, Pain, Cardiovascular and Metabolism. Judith has many years of experience in Regulatory Affairs and drug development in Novartis - working in different areas such as Oncology and Infectious Diseases, where she was involved in the development and approval of an antimalarial drug, and as the EU Regulatory Head of the Cardiovascular and Metabolism Group where she was involved in the successful development, approval and life cycle management of some key products of Novartis. Judith is now Head of EU Liaison and Policy in Drug Regulatory Affairs at Novartis where she is involved in Health Authority Liaison and also represents Novartis in various working groups in Industry Trade Associations such as EFPIA. Topics lectured Seminar 1:
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Dr. David M. Cross, Cross Pharma Consulting Limited Dr. David M. Cross is a former 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 overview. He has a PhD in Biochemistry and a BSc in Cell Biology and Immunology. David is currently a freelance consultant for Cross Pharma Consulting Limited, in the UK. Topics lectured Seminar 5:
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Dr. Simon Day, Roche Products Limited Simon has spent more than 25 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He currently works for Roche as a global statistical and regulatory consultant within the Statistical Methods and Research (SMR) Group. In this role he works across all therapeutic areas and phases of drug development. Topics lectured Seminar 4.2:
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Dr. Siska De Moor, Merck Sharp & Dohme Dr. Siska De Moor obtained her degree of Pharmacist in 1995 and an additional degree in Hospital Pharmacy in 1996 from the Catholic University Leuven in Belgium. Topics lectured Seminar 5:
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Dr. Jacques Descotes, University of Lyon Dr. Descotes, MD, PharmD, PhD, is professor of medical pharmacology at Lyon University and Head of the Poison Center and Pharmacovigilance Department at Lyon University Hospitals.For the past 30 years he has been involved in the non-clinical and clinical safety evaluation of pharmaceuticals in particular from an immunotoxicological perspective. He is a fellow of the US Academy of Toxicological Sciences and a Eurotox Registered toxicologist. Dr. Descotes is the author of 14 books devoted to immunotoxicology, human toxicology and drug safety, and over 300 original and review articles. Topics lectured Immunogenicity Integrated - Interactive Workshop:
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Dr. Ji-cui Dong is a pharmacist and has a PhD in Biology. In China she was a lecturer at the University and she did her PhD in biology at the University of Geneva. She Joined WHO in 2001 and she is technical officer in the INN Programme in the Department of Essential Medicines and Pharmaceutical Policies. Topics lectured Seminar 4.1:
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Dr. Hoss Dowlat, was until Summer 2010, Vice President, Technical, Drug Development Global Strategy Services, responsible for EU, USA, Japan, China, Korea, and Latin America drug development and regulatory submissions at the leading CRO PAREXEL. He was with PAREXEL CONSULTING 2000-2010. Hoss is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has over 30 years of experience in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs. He has extensive experience with European, EMA and FDA submission procedures, US/EU Scientific Advice, and with eCTD-NDA/BLA//MAA or IND/CTA conversions. He is a pioneer in international Biosimilar (follow-on-Biologics) Drug approvals leading one of the first of two European Biosimilar Marketing Authorizations MA, unprecedented approvals, in 2006. Also, he has substantial biologics and small molecules Orphan Drugs experience. His expertise includes regulatory affairs strategy/operations, drug discovery/design and pharmaceutical development, clinical research and medicinal safety. This includes implementing, for clients, recent 2006-2008 requirements on European Paediatric Investigational Plans (PIP) and Risk Management Plans (RMP) to ensure submission compliance and approvals. Furthermore, he is an international regulatory affairs strategic expert and thought leader in US/EU product information/labeling of medicines. He pioneered Readability and User Testing of patient information leaflets from 2000-present. He has authored several articles and scientific publications, and has given numerous presentations at industry conferences and trainings on drug development and regulatory issues. Clients have also taken advantage of his extensive experience across over 15 therapeutic disciplines in conducting due diligence of new drug candidates and technology platforms in an EMEA/FDA regulatory framework. Topics lectured Seminar 1:
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Dr. Anne Dupraz-Poiseau, Voisin Consulting Dr. Anne Dupraz-Poiseau manages projects involving the design and the implementation of regulatory strategies for the development, evaluation and marketing of Advanced Therapy medicinal Products (ATmPs), medical devices and drug/device combination products. Anne has broad experience in preclinical and clinical program design and implementation, in regulatory submissions and in scientific writing. As an industry expert, she actively participates in the development of EU legislations, the most recent being the European Regulation on ATMPs and the EU Commission consultation process for the revision of the EU medical device Directive. Anne also specializes in Quality regulations, such as ISO 9001 and ISO 13485, QSR (21 CFR part 820), GCP (Good Clinical Practices: ICH E6), and GLP (Good Laboratory Practices). Prior to joining Voisin Consulting, Anne co-founded the consulting firm Meditest International, based in Rennes, France. She began her career as Research & Development Project Manager for Medtronic Sofamor-Danek. Dr. Dupraz-Poiseau has spoken at a number of international conferences, among them the RAPS (Regulatory Affairs Professional Society) and life sciences meetings. Anne is also a member of the Regulatory Affairs Journal Device (RAJ Device) editors’ board and writes for international publications. Topics lectured Seminar 1:
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Dr. Thomas Ecker, EPC Healthcare Ltd. The main focus of Dr. Thomas Eckers strategic concepts are healthcare politics and healthcare economics. Thomas Ecker achieved his universitary and scientific education at the University of Bayreuth and Strathclyde in Scotland. His professional career started at the Institute of the University of Bayreuth as managing director. From 2000 until 2003 he worked as senior consultant at GCI management consulting. From 2004 to 2006 he established the HTA and department at the IGES Institute in Berlin. He´s health economist, expert for healthcare, healthcare politics and outcomes research. Topics lectured Seminar 8:
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Dr. Monika Eck-Schaupp, NDA Regulatory Service Ltd. Monika Eck-Schaupp is the Deputy General Manager and Director Regulatory Affairs from NDA Regulatory Service GmbH in Munich. Over a period of more than 15 years gathered extensive experience in MAAs under Centralised Procedure, Mutual Recognition Procedure, Decentralised Procedure and National Procedures, incl. - Initiation and finalization of the centralized registration procedure for three products - Initiation and finalization of mutual recognition procedures and decentralized procedures for several new drugs and generics including the national implementation phase and issuing of the national licenses (from 1998, two procedures ongoing as of June 2010). Monika has brought experience in - Regulatory strategy for product registration in Europe - National and EMA scientific advice procedures for new development projects - Development, registration and license maintenance in over 50 countries across Europe, Central Eastern Europe, Middle East, Israel and South Africa incl.: EU Article 18 Referral triggered by EMEA (2006), EU Article 30 Referral (SPC harmonization across Europe) triggered by Marketing Authorisation Holder (2006), EU Article 30 Referral by European Medicines Agency (2009). Topics lectured Seminar 1:
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Prof. Dr. Rembert Elbers, Federal Institute for Drugs and Medical Devices Topics lectured Seminar 1:
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Dr. Daryl Fernandes, Ludger Ltd. Topics lectured Seminar 4.1:
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Dr. Marielle Fournier, Voisin Consulting 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). Topics lectured Seminar 1:
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Dr. Sergio Fracchia holds a Doctorate Degree in Biological Sciences from the University of Torino and a PhD in Biotechnology from the Milan University. Dr. Fracchia worked from 1988 to 2001 at the Institute for Biomedicine Research A. Marxer in several positions including Study Director, Head of Electron Microscopy Laboratory and Head of Cell Bank Validation Service. In the year 2001 he became QC Manager of MolMed Spa where he is currently working as Regulatory Affairs Manager. He is responsible for the Dossiers preparation and submission to Italian and International Regulatory Authorities as well as for the pre-clinical and clinical regulatory development of the ongoing projects. Topics lectured Seminar 3:
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Prof. Dr. Edward Geissler, University of Regensburg, Medical Centre 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. Topics lectured 2nd Annual EUCRAF Workshop:
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Dr. Dave Gilbert, NDA Regulatory Science Ltd. Dave Gilbert, a NDA Adivisory Board member since 2003, started to work as a freelance Consultant in 2011. The years before he has been Managing Director at NDA Advisory Board, Vice President and Head of Regulatory Affairs at Pharmacia, UK. Before he became Head of EMEA Liaison and Regulatory Intelligence at Novartis in 1998 he worked as Director for Novartis Europharm Limited. His area of expertise includes EU strategic regulatory input to development, EU submissions and approvals, Scientific Advice, Orphan Drugs, Oral explanations at EMA, Health authority interactions and trade association interactions. Topics lectured Seminar 2:
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Following a PhD in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd. in 1984 to found the Biochemical Services Department. Here she pioneered and applied developments in Mass Spectometry for structural characterisation. She was appointed Director of Biochemical Services in 1988. At the same time she was instrumental in establishing a facility in the United States where she was appointed Vice President. Dr. Greer was responsible for establishing the Quality Management Systems and for directing Quality Assurance across the four M-Scan laboratories. With over 30 years of experience in the structural analysis of glycoproteins using instrumental techniques she has published many articles on the use of mass spectrometry to fulfil regulatory characterisation requirements. She is regularly invited to give presentations at international meetings and has designed and presented various training cources. She is now Global Director for Biopharma Services Development, SGS M-Scan. Topics lectured Seminar 4.1:
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Dr. Ronald Grobe-Einsler, Consultant, formerly Bayer 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 1983 Medical Director Germany at Bayern 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. Topics lectured Seminar 4.2:
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Dr. Steffen Gross, 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-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. Topics lectured Seminar 2:
2nd Annual EUCRAF Workshop:
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Dr. Agnes Gyurasics, National Institute of Pharmacy, Hungary Dr. Agnes Gyurasics is graduated from University Medical School of Pécs, Hungary, where she became faculty member of Department of Pharmacology and Toxicology (teaching medical students, and research on pharmacokinetics of xenobiotics). Afterwards she worked part time at the Perinatal Intensive Care Unit of the University’s Obstetric’s Clinic followed by two years research fellowship at Baylor College of Medicine, Section Neonatology of Department of Paediatrics, Houston, Texas. Dr. Gyurasics is board certified in clinical pharmacology and in toxicology. After joining to National Institute of Pharmacy she has been assessing the nonclinical and clinical parts of clinical trials and marketing authorization application dossiers. After leading the Department of Medicine and Biology now as the chief advisor of the Director General she has been participating in different EMA activities. She has been acting as one of the connecting persons between the CHMP and PDCO. Topics lectured Seminar 5:
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Kathy Hartmann-Campbell, Communication Coach 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. Topics lectured Seminar 9:
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Dr. Erika Harzer, Sanofi Pasteur MSD GmbH Dr. med. Erika Harzer is Medical Director at Sanofi Pasteur MSD GmbH. Her doctoral degree in the field of phoniatrics and audiology she gained in 1985 from the University of Hamburg. From 1982 to 1984 she worked at Beiersdorf AG in Hamburg as Medical Advisor. In 1985 she changed to Institut Mérieux GmbH, where she worked as Medical Advisor since she started to work for Sanofi Pasteur MSD GmbH in 1995. Topics lectured Seminar 4.2:
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Dr. Thomas Hecker is licensed pharmacist since 1994. He became Specialised Pharmacist in Toxicology and Environmental protection in 1998. He also holds a PhD in Pharmaceutical Chemistry. From 2002 to 2007 he worked as GMP/GCP Inspector in Federal State of Thuringia. In 2007 he started working for EDQM where he is currently GMP inspector. Topics lectured Seminar 7:
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Dr. Susanne Heiland-Kunath, Nycomed In her current position Susanne Heiland-Kunath is heading the Konstanz site of international regulatory affairs in Nycomed. She has a working experience of more than 10 years in the field of international regulatory affairs for development products at Nycomed. She has been involved in the development, approval and lifecycle management of products in different areas such as Gastroenterology, Respiratory diseases and most recently 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 50 countries for a key respiratory product at Nycomed. 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. Topics lectured Seminar 8:
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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. 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 is registered as a Qualified Person with Swiss Medic. In the time that Ralf has been at PAREXEL (more than 5 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. Topics lectured Seminar 7:
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Dr. Lois Hinmann, Novartis Pharmaceuticals Corporation, USA 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. Topics lectured 2nd Anuual EUCRAF Workshop:
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Dr. Esther Imboden, Regulix Ltd. Dr. Esther Imboden is Director of REGULIX LTD, Regulatory Affairs Consultancy in Switzerland. She has a technical background with more than 17 years regulatory affairs experience in the pharmaceutical industry and an extensive understanding of all aspects of the European and Swiss Licensing Procedures and the FDA (CBER) regulatory processes specifically in the product registration of sterile biological preparations as well as production plant submissions. Before the foundation of her own company in 2001, where she offers national and international regulatory affairs consultancy, specifically in the field of product registration of sterile preparations, biological products as well as registration of production plants, she has been working for ten years as Director, respectively as Senior Manager of Drug Registration and Regulatory Affairs at ZLB Zentrallaboratorium BSD SRK and ZLB Bioplasma AG in Switzerland. Topics lectured Seminar 2:
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Dr. Michelle Jessen, Micromet, USA Dr. Frazier-Jessen has over 11 years of experience in the biotechnology regulatory affairs field and is currently employed at Micromet, Inc. as Senior Director, Regulatory Affairs. Prior to joining Micromet, she was employed at Macrogenics, Inc. and MedImmune, where she held positions with increasing levels of responsibility. Prior to her employment in the biopharmaceutical industry, Dr. Frazier-Jessen was a Review Biologist and Acting Team Leader in the Division of Monoclonal Antibodies, Office of Biotechnology Products at CDER, FDA. Her responsibilities at FDA included research into the role of cytokine signaling in monocytes and macrophages as well as review of Chemistry, Manufacturing and Controls sections of investigation New Drug (IND) applications, biologics license applications (BLAs) and supplements. Dr. Frazier-Jessen also participated in Pre-Approval Inspections (PAIs) and Biennial inspections as a Product Specialist. She is active in numerous professional societies and is an Associate Director for CASSS (California Separation Science Society). Dr. Frazier-Jessen earned her bachelor’s degree in Microbiology from Washington State University and her Ph.D. in Cell Biology, Neurobiology & Anatomy from Loyola University Chicago. She has over six years of post-doctoral research training experience in cell biology/immunology/inflammation. Topics lectured Seminar 8:
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Dr. Angelika Joos, Merck Sharp & Dohme Angelika Joos is a licensed pharmacist. Since 2001 she is responsible for regulatory policy issues at Merck Sharp & Dohme's Regulatory Affairs department in Brussels. Before focusing on policy she was working at the European and German Regulatory Affairs departments of MSD as well as for Nycomed Arzneimittel GmbH. Over the past 15 years, Angelika has gained strategic as well as operational experience with all regulatory procedures and various products in different therapeutic areas. In her current position as Head Regulatory Policy EU & Most of World she is responsible for monitoring and implementing regulatory policies & procedures and advising the company on regulatory strategies. One of her current priorities includes the implementation of the Paediatric Regulation into the EU regulatory framework. Since 2004 she is a member of the EFPIA Regulatory Liaison Committee and specifically involved in activities related to paediatric policies. She is also a company delegate to the IFPMA Pediatric Task Force established in 2008. In addition she is co-chairing the global Merck Pediatric Development Committee since 2011. Topics lectured Seminar 5:
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Prof. Dr. Manfred Jung, University of Freiburg Prof. Dr. Manfred Jung has a Ph.D. in Pharmaceutical Chemistry. As Postdoc he worked for two years at the University of Ottawa. In 1994 he became group leader at the University of Münster and habilitated in 2001. Currently he is Professor of Pharmaceutical Chemistry at the University Freiburg. His research interests are chemical epigenetics, drug discovery and assay development as well as inhibitors of histone modifying enzymes. He already obtained several awards and fellowships – in the years 1997 and 1999 he got the “Habilitation fellowship German Pharmaceutical Society” and in the year 2000 he obtained the “Habilitanden-Award Medicinal Chemistry”. Topics lectured Seminar 3:
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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. Topics lectured Seminar 7:
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Dr. Thomas Kirchlechner, Sandoz GmbH Regulatory Affairs Biopharmaceuticals 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 10 years experience in the pharmaceutical industry, including finished dosage form production, active ingredient strategic sourcing, and, for the last 7 years, in regulatory affairs specializing in biopharmaceutical and biosimilar products at Sandoz GmbH Kundl, Austria. Topics lectured Seminar 4.2:
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Dr. Manuela Kohler, Pharmatching GmbH She joined Pharmatching GmbH in November 2009 as Director Partnering Consulting and Principal Consultant. She has 20 years experience in regulatory affairs and drug development. In her previous role as Service Line Lead for late stage product development at Parexel Integrated Product Development Consulting, one of the largest global CROs, she supported clients with her experience and expertise in European and international product development and registration of pharmaceutical products. This included provision of strategic advice on optimal European regulatory strategy, planning and implementation of consultation meetings with Regulatory authorities to obtain input on strategic regulatory and technical issues. She was also responsible for business development of the late stage product development services and for implementation of methodologies to strengthen internal processes and quality assurance. Dr. Kohler conducted due diligence processes in licensing processes and has been in charge of a range of services related to the development of regulatory submissions including gap analysis of registration dossiers, development, compilation and submission management of Marketing Authorisation Applications, Orphan Drug Applications, SME applications, Variations, Briefing Books for Scientific Advice procedures and others. Topics lectured Seminar 1:
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Dr. Hartmut Krafft, Paul-Ehrlich-Institut Dr. Hartmut Krafft gained his Master degree and PhD thesis at the German Cancer Research Center Heidelberg, Departement of Cell Biology and Immunology. As Post-Doc he worked at the German Cancer Research Centre and the Euopean Molecular Biology Laboratory in Heidelberg as well as for the Institute of Pathology at the University Hosipital 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. Topics lectured Seminar 2:
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Dr. Boris Kreye is an experienced national and international patent litigator. He represents national and international clients before all German patent infringement courts including the Court of Appeals Düsseldorf. He has particular expertise in the fields of electronics and telecommunication, mechanics, medical devices, chemistry and pharma. Besides that, Boris represents clients in oppositions and nullity proceedings at the EPO, the German Patent and Trademark Office, the Federal Patent Court and the Supreme Court . Over and above, Boris advises clients in all other IP matters such as trademark, unfair competition law and design rights. Boris has experience in ICC arbitration proceedings and evidence proceedings under the Hague Convention. Boris is noted in the German legal directory JUVE as a frequently recommended lawyer for patent infringement proceedings. Before joining the Munich office of Bird & Bird in January 2004, where he is heading the patent litigation group, he worked in the IP group of a large German and later on British law firm in Düsseldorf. He studied law at the University of Hamburg and received a Master of Laws degree from the University of Houston in 1999. Boris regularly publishes articles in legal and commercial magazines. He is a member of the German Association for Intellectual Property and Copyright (GRUR), the German/Japanese Lawyers Association as well as EPLAW, IPO and AIPPI. Topics lectured Seminar 8:
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Dr. Arno Kromminga, IPM Biotech PD Dr. Arno Kromminga is founder and CEO/CSO of GLP-certified IPM BIOTECH, is heading the Immunology at the Clinical Laboratory Lademannbogen in Hamburg, Germany, and has a position at the University of Kiel, Germany. He studied biochemistry and immunology and has 15+ year experience in assay development and is author of multiple publications in peer-reviewed journals and books. He is cofounder of the European Immunogenicity Platform (EIP). He gained substantial industrial experience in various biotech companies. He has been involved in the development and establishment of novel immunological and cellular assays for immunogenicity testing and PK/PD analysis for pre-clinical and clinical studies in compliance with GLP regulation. Most importantly he aims to interpret ADA, PK/PD data in the context of clinical consequences and manifestations. Topics lectured Immunogenicity Integrated - Interactive Workshop
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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. Topics lectured 2nd Annual EUCRAF Workshop:
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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. Topics lectured 2nd Annual EUCRAF Workshop:
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Dr. Avril Mankel, NDA Regulatory Services Dr. Avril Mankel has a PhD in Cell and Developmental Biology and is currently working as 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. Topics lectured Seminar 5:
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Dr. Jaques 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 Jaques Mascaro is currently Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Quality Assurance at Elan Pharma International. Topics lectured Seminar 8:
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Dr. Beatrix Metzner, Merck Serono 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 became Regulatory Strategy Manager in Global Regulatory Oncology. Since November 2008 she has been working as Director, Head of Global Regulatory Oncology EU I. Topics lectured Seminar 4.1:
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Dr. Geneviève Michaux, Covington & Burling LLP Geneviève Michaux is Of Counsel at Covington & Burling. She received her licence en droit from the Université Libre de Bruxelles in 1988 and her LLM from Harvard Law School in 1996. She is a member of the Brussels Bar and of the Paris Bar and is a mediator with the Brussels Business Mediation Center. Ms. Michaux specializes in European, Belgian and French food and drug law with particular emphasis on pharmaceuticals and food supplements. Her work covers a wide range of issues, including: regulatory status of borderline products, clinical trials, life cycle management, labelling and promotions, data privacy. She regularly provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has helped - among other matters - shape the new EC Paediatrics Regulation. She also has broad litigation experience in life science matters including product liability, advertising and promotional activities. Ms. Michaux has published numerous articles on food and drug law and regularly speaks at international food and drug conferences. In addition to her work in food and drug law Ms. Michaux also practices Belgian commercial law. She has extensive experience in all aspects of Belgian commercial law such as distribution, unfair trade practices and employment and regularly represents clients before the Belgian courts. Topics lectured Seminar 5:
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Dr. Leyna Mulholland, Hoffman-La Roche Inc. Leyna Mulholland, PhD, is Director of Global Product Development Regulatory Affairs at Hoffman-La Roche, Inc. Dr. Mulholland began her career as a Research Investigator at University of Michigan Medical School in the areas of cancer research after obtaining her PhD in Toxicology from the University of Michigan. Leyna started her non academic career in the regulatory affairs division in the State of Michigan’s human health division as a food safety manager supported by USFDA and as a project manager in a firm leading risk assessment and management projects for several large pharmaceutical clients. She moved into the drug regulatory affairs area by consulting with several pharmaceutical companies to develop global strategies for clinical trials through streamlining drug development processes. She has more than 18 years of experience in global drug development and had worked in broad areas of drug development from preclinical to clinical development. Previously she worked in large US Pharmaceutical companies –in Merck USA in the area of Japan Pharmaceutical Development for eight years and with Eli Lilly HQ in Global Clinical Research. Leyna is currently working in Tokyo, Japan in a Roche’s Partner Company Chugai Pharmaceutical Inc. as the Regulatory Liaison to support Roche group for global drug development by maximizing science, the ICH guidelines, and through paying careful attention to the Japanese regulations and global clinical trials including Asia. Topics lectured Seminar 2:
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Dr. Bernd Müller-Beckmann, Roche Diagnostics GmbH Bernd Müller-Beckmann has more than 30 years experience in pharmaceutical industry where he held various scientific and managerial positions in the field of preclinical drug research & development and clinical development. Until recently he was the coordinator for preclinical safety at Roche’s Pharmaceutical Research and Development Center in Penzberg, Germany. Prior to this assignment he served as Global Coordinator for Biopharmaceuticals Safety at F. Hoffmann-La Roche Ltd., Basel, Switzerland. Under his leadership a company guideline for the non-clinical safety evaluation of biopharmaceuticals was developed, now a globally harmonized internal standard reference. In earlier roles as scientist and head of pharmacology & toxicology he was involved and contributed to the discovery and preclinical development of a number of novel small molecules and biologics for various therapeutic areas, i.e. oncology, bone metabolism, diabetes, lipid metabolism and cardiovascular diseases. Bernd Müller Beckmann studied veterinary medicine at the universities of Berlin and Giessen. He holds a Ph.D. from the university of Giessen and is a board certified specialist for pharmacology and toxicology. Topics lectured Seminar 4.2:
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Dr. Jan Mueller-Berghaus, 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. Topics lectured Seminar 8:
2nd Annual EUCRAF Workshop:
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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. Topics lectured 2nd Annual EUCRAF Workshop:
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Tilo Netzer is a pharmacist by training and holds a PhD in Pharmacology. He started his career with Merck KGaA in Germany in 1992 and held since then various positions in Clinical Development and Regulatory Affairs where he significantly contributed to the successful development as well as marketing authorization of Erbitux. In the context of the integration of Merck and Serono in 2007 he became Head of Global Regulatory Oncology and since January 2009 he is Head of Global Regulatory Affairs at Merck Serono. Topics lectured Seminar 2:
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Dr. Gesa Pellier, Novartis Pharma AG Senior Regulatory Affairs Professional with 20 years regulatory experience across a broad variety of therapy areas. 7 Years at Local level (Germany). 13 Years at Region / Global level (8.5 years in regional role, 4.5 years in therapeutic area roles Current Appointment (since 07/08): DRA Head Europe Lead of all regulatory aspects of development and marketed products in Drug Regulatory Affairs in Europe. Responsible for resource planning and utilization of Basel-based DRA group, including DRA associates in all European Country Pharma Organisations Previous Novartis appointments 01/08 – 06/08: Global DRA Head, Immunology and Infectious Diseases. Global Leadership of a team of regulatory professionals, providing regulatory support for a broad portfolio of programs, projects and brands in the Immunology and Infectious Diseases Business Franchise in various stages of development and Health Authority review. 08/07 - 12/07: Global DRA Head, Ophthalmology, Dermatology, Gastroenterology, Urology 01/07 - 07/07: Global DRA Head, Dermatology, Gastroenterology, Urology 04/06 - 12/06: EU DRA Head, Arthritis, Bone, Gastroenterology, Urology 04/05-03/06: Senior Regulatory Manager with global responsibility for a GI drug (Zelmac/Zelnorm) Topics lectured Seminar 1:
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Dr. Silvia Pfaff, 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. Topics lectured Seminar 1:
Seminar 9:
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Dr. Michael Pfleiderer, Paul-Ehrlich-Institut Dr. Michael Pfleiderer is currently working for the Paul-Ehrlich-Institut in Langen as Head of the field virus vaccines. He is 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 the laboratory for genetically research and afterwards Head of the Department Recombinant Vaccines. Topics lectured Seminar 3:
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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. Topics lectured Seminar 6:
2nd Annual EUCRAF Workshop:
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Dr. John Purves, Consultant, formerly EMA Dr. John Purves is a life science consultant having recently retired from the European Medicines Agency where he worked for 14 years, first as head of the biotechnology and biological products sector and most recently, as head of the sector for the quality of medicines. He was involved in many areas dealing with biological medicinal products, including biosimilar, influenza and advanced therapy products. Prior to joining the EMA, Dr Purves was manager of the biotechnology and biological unit at the UK Medicines Control Agency, now the Medicines and Healthcare products Regulatory Agency. At the UK agency, he was involved in the drafting of a number of European Union guidelines including those on the manufacture and control of recombinant-DNA products and products derived from human blood and plasma. Dr Purves also oversaw efforts to minimise the risk of the transmission of spongiform encephalopathies to humans through medicinal products. Dr. Purves graduated in pharmacy from the Heriot Watt University in Edinburgh in 1968 and received his doctorate in pharmaceutical microbiology from the University of Strathclyde in 1973. Following university, he worked in research and development at Smith and Nephew Ltd in the UK. Topics lectured Seminar 1:
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Dr. Bernd Raffelsberger, Pfizer 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 today he is Head of the Quality organization of Pfizer Freiburg. Topics lectured Seminar 7:
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Dr. Jürgen Regenold, Dr. Regenold GmbH Jürgen has started the business in 1994 and is sole shareholder in the company. Beginning in 1990 he worked in both the management of pharmaceutical product development and in regulatory affairs. Today, he is involved in strategies for product development, regulatory affairs, and networking to support an efficient realisation of client's projects. Although the nature of the company requires him to spend a certain level time to administrative work, he remains actively involved in all projects handled by his teams. In 1996 Jürgen started to identify regulatory expertise and resources in selected European to further develop these resources into "regulanet®", a network of collaborative partners throughout Europe and the USA. In 2000, Linda Woods and Jürgen started "UKR Regulatory Affairs Limited", a UK-based operation. Topics lectured Seminar 1:
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Dr. Birgit Reipert, Baxter BioScience Birgit Reipert, PhD, is Director of the Department of Immunology within the Franchise Hemophilia/Hematology at Baxter BioScience. In addition she has got a lectureship at the Medical University of Vienna (Austria). She received her PhD from the Ernst-Moritz Arndt University, Greifswald (Germany), and postdoctoral training at the Institute for Medical Immunology at the Charitè, Berlin (Germany), at the Department of Immunology of the Institute for Cancer Research, Berlin and at the Paterson Institute for Cancer Research, Manchester (UK). Birgit Reipert joined Immuno AG in 1994 and Baxter AG in 1997. Birgit Reipert has a long standing interest in the immunogenicity of therapeutic proteins and in the search for new approaches to prevent unwanted immune responses to these proteins. Topics lectured Immunogenicity Integrated - Interactive Workshop:
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Dr. Ilona Reischl, AGES - Austrian Medicines and Medical Devices Agency Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/PharmMed Topics lectured 2nd Annual EUCRAF Workshop:
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Dr. Ruth Rettenmeier, PAREXEL International GmbH Dr. Ruth Rettenmeier is a Biologist with over 14 years broad scientific and regulatory experience in preparation, compilation and submission of regulatory applications, approval and post approval processes with focus on Module 1 and Labelling topics for all kinds of MAAs in all 29 EU countries and non-EU countries (Switzerland). She is organizing/managing complex Language Service projects from/into all 24 EU/EEA languages within the Linguistic Review Process of centralised and decentralized procedures, as well as currently handling pilot projects in PIM (Product Information Management), a new system and standard (Light Authoring Tool) for managing and exchanging electronic product information between applicants and EMEA/competent authorities. She is also consulting on Mock-up and Readability services. Topics lectured Seminar 2:
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Dr. Gabriele Schäffner-Dallmann, Study Director EUCRAF/ CEO Pharmatching GmbH 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 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. Topics lectured Seminar 1:
Seminar 2:
Seminar 3:
Seminar 4.2:
Seminar 7:
Seminar 8:
Seminar 9:
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Dr. Florian Scheich, Roche Diagnostics GmbH Dr. Florian Scheich holds a Diploma in Biology from the University of Würzburg. His PhD studies in the field of Immunology he did at the Technical University of Munich. Since 2007 he is working at Roche Diagnostics GmbH, Penzberg, as Manager Technical Regulatory Affairs. Topics lectured Seminar 4.1:
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Dr. Christian K. Schneider, Danish Medicines Agency 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. Topics lectured Seminar 1:
2nd Annual EUCRAF Workshop:
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Dr. Ole Schou, formerly Novonordisk Dr. Ole Schou studied at the University of Copenhagen. He started his career at the Danish Institute of Protein Chemistry. In 1983 he changed to Novo Industry A/S (since 1989: Novo Nordisk A/S). From 2000 to 2002 he worked at ZymoGenetics Inc.. After these two years, he moved back to Novo Nordisk where he stayed until he retired in 2009. Topics lectured Seminar 4.1:
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Dr. Gabriele Schricker, Wilex AG Dr. Gabriele Schricker is Project Manager R&D for drug development in Oncology (small molecules) at Wilex 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 13 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 10 years for 5 biopharmaceutical companies in Germany, Switzerland and Italy. Furthermore, she is engaged in team development and personality coaching since more than 8 years and co-founder of “Kompetenz-Netzwerk für Coaching und Psychotherapie”. Topics lectured Seminar 9:
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Dr. Robert Schultz-Heienbrok, Xendo 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 7 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 for Xendo Deutschland GmbH, a German subsidiary of the Dutch pharmaceutical service company Xendo B.V. His group focuses on regulatory strategy of marketed products (MRP, line extensions, variations) and regulatory consultancy for biopharmaceutical developments. Besides running Xendo Deutschland he is responsible for the IT strategy of the entire Xendo Regulatory Affairs Division. Topics lectured Seminar 9:
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Dr. Dunja Schumacher, NDA Regulatory Science Ltd. Dunja Schumacher is a Pharmacist and graduated in 1997. From 1997 to 2000 she worked at Schering AG in Berlin where she was responsible for product information. Afterwards she worked at EMEA, London as Product Team Leader Quality of Medicines Sector and Secretary of Quality Working Party, Inspections Sector. Since 2006 she is working at NDA Regulatory Sciences, UK. She is previously responsible for setting up the NDA Training Academy, now Senior Regulatory Consultant NDA Advisory Board. Topics lectured Seminar 2:
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Dr. Martina Schwinger, 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. Topics lectured 2nd Annual EUCRAF Workshop
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Dr. Diane Seimetz, Fresenius Biotech Diane Seimetz, PhD, MDRA, is Executive Vice President and Chief Scientific Officer of Fresenius Biotech. Dr. Seimetz received her degree in pharmaceutical science in 1996 from the University of the Saarland, Saarbruecken (Germany). In 1999 she completed her PhD at the University of Heidelberg. Her research work was conducted at the German Cancer Research Center where she worked in collaboration with a pharmaceutical company towards glycotargeting in oncology. The collaboration with industry, which also involved pharmaceutical product development through to preclinical studies and clinical trials, aroused Dr. Seimetz’s interest in regulatory affairs. During her PhD studies she also received a German Academic Exchange Service (DAAD) scholarship to conduct research at the Johns Hopkins University in Baltimore (USA). Dr. Seimetz received her Master’s Degree in Drug Regulatory Affairs (MDRA) in 2002 from the University of Bonn. In her master thesis she assessed the EU and US environment for early market access and the essential requirements within a pharmaceutical company. Dr. Seimetz joined the Fresenius Group in 1999. With her background as pharmacist, she set up and developed the International Regulatory Affairs Department at Fresenius Biotech, where she was then promoted to Vice President and Head of Department. In this function she was responsible for global egulatory affairs of biological and biotechnological products in oncology and immunotherapy. In 2008 Dr. Seimetz was promoted to Executive Vice President and Chief Scientific Officer of Fresenius Biotech. In this function she is responsible for Clinical Development and Medical Affairs, Preclinical Development, Regulatory Affairs and Program Management. Dr. Seimetz has been closely involved in the development of the trifunctional antibody catumaxomab (Removab®) since 1999. In April 2009 this antibody, first in class, obtained approval from the European Commission for the treatment of malignant ascites. In 2010 Removab® was awarded the “Galenus von Pergamon Prize” which honors outstanding research and innovative drug development. Topics lectured Seminar 4.2:
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Dr. Karin Sewerin, BioPharmaLinx AB Dr. Karin Sewerin holds a PhD in Pharmaceutical Biochemistry from the University of Sweden. Currently she is working at NDA Regulatory Service AB in Sweden as well as for BioPharmaLinx AB as Senior VP for Quality and Regulatory Operations. From 1995 to 2002 she worked for Genentech, San Francisco as Director QC Analytical Technologies and later as Director Regulatory Affairs. Afterwards she changed to Biologics Consulting Group LLC where she worked as Senior Consultant. From 2004 to 2006 she worked for BioTech Development Sweden AB as Senior Consultant. Before she started at NDA Regulatory Service in 2008 she worked for two years as Global Regulatory Affairs Director, CMC Biotech Products at Astra Zeneca. Topics lectured Seminar 4.1:
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Dr. Wiebke Siegel, former inspector at RP Darmstadt Wiebke Siegel is a pharmacist. After experience for near twenty years in clinical pharmacy and later one pharmaceutical supply of hospitals she changed to the Paul-Ehrlich institute. There she was in the section Hematology and transfusion medicine involved in regulatory affairs including inspections for blood products. 2002 she moved to the pharmaceutical department of the Regierungspräsidium Darmstadt. Here she was responsible for the manufacturing authorization of blood products and biological medicinal products like stem cells, tissues, reproduction medicine and plasma derived products as well as other pharmaceutical products and also for the inspection of pharmaceutical manufactures. She got experience in European pharmaceutical legislation, was some years head of the German Expert group Blood and is member of the national working group blood. She has also experience in international GMP-inspections worldwide for pharmaceutical products. She retired in 2010. Topics lectured Seminar 7:
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Dr. Jennifer Sims, Integrated Biologix Ltd. 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.Topics lectured Seminar 4.2:
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Dr. Michael Soldan, Biotest AG Dr. Michael Soldan holds a PhD in Human Biology/Pharmacology from University Marburg. After one year as postdoctoral research fellow at University Marburg he worked for three years as Regulatory Affairs Manager at Centeon GmbH (now Aventis Behring GmbH). In 2001 he became Head of Regulatory Affairs Group at Hemophilia Europe. From 2003 to 2005 he was Head of Regulatory Affairs at Chiron Behring GmbH (now Novartis Behring). In 2005 he changed to Gruenenthal GmbH where he was Head of Corporate Regulatory Affairs. He held the same position at Biotest AG from 2006-2008 until he became Senior Vice President of the Medical/Regulatory Affairs Business Unit. Topics lectured Seminar 8:
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Dr. Anna Somuyiwa, Segulah Consulting Ltd Anna Somuyiwa is an independent regulatory affairs professional with over five years’ of new licence submission and maintenance in the European Union using national, Decentralised, Mutual Recognition and Centralised procedures for abridged applications for small molecules; experienced in the preparation of necessary supporting documents and management of complex European registration projects, registration strategy, agency liaison, chemistry-manufacturing-control (CMC), commercial and intellectual property issues. Trained and experienced in the development and delivery of relevant and effective regulatory training courses to staff with various experience levels; Anna was one of five recipients of DIA Young Professional Fellowship award for the EuroMeeting 2010 held in Monaco. She is currently working as Regional Regulatory CMC Country Manager (Emerging Markets) for an international ethical pharmaceutical company, responsible for CMC strategy of existing and new products within designated regions. In the past she has worked for Teva Pharmaceuticals, Sanofi-Aventis and Ranbaxy UK in London. Topics lectured Seminar 2:
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Dr. Ashley Strougo, Astellas Pharma Global Development Europe 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. Topics lectured Seminar 5:
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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. Topics lectured 2nd Annual EUCRAF Workshop:
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Dr. Gertrud Thormann, The Hst Consulting Network Ltd. 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. Topics lectured Seminar 9:
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Dr. Ralf Tönjes, Paul-Ehrlich-Institut Dr. Ralf Reinhard Tönjes (RRT; German) is research scientist and group leader at Paul- Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines, Division of Medical Biotechnology, Langen, Germany. RRT is at PEI since 1991. At current, he is head of section “Non-vital tissue preparations, Xenogeneic cell therapeutics”. As such he is concerned with the fields of human tissue preparations and xenotransplantation. He founded the German working group for xenotransplantation (DAX) in 1998. He teaches as an associate professor (Außerplanmäßiger Professor) for biochemistry at Goethe University, Frankfurt/Main, Germany. RRT’s area of research is focused on endogenous retroviruses and retroelements of men and animals. Topics lectured Seminar 4.2:
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Dr. Lincoln Tsang, Arnold & Porter LLP Dr. Lincoln Tsang is a partner of Arnold & Porter LLP advising on both contentious and non-contentious matters affecting healthcare industry. He qualified as a lawyer, a pharmacist and a toxicologist. In addition to advising life sciences industry, he advises certain governmental organisations in the UK and overseas. By ministerial appointment in the UK, he serves as a non-executive member of the Regulatory Oversight Committee of the Health Protection Agency; a Commissioner of the British Pharmacopoeia Commission; Chairman of the Biological Specialists Group and Vice Chair of the Nomenclature Committee of the British Pharmacopoeia Commission; a member of the Governing Council of the London School of Pharmacy. He is a member of the UK Ministerial Industry Strategy Group New Technology Panel. He served for two terms as a non-executive director on the board of the National Institute for Biological Standards and Controls. He was a contributor to the recent publication by the Academy of Medical Sciences entitled“Safety of Medicines”. He was head of biologicals/biotechnology of the UK Regulatory Agency, an advisor to the European Medicines Agency, European Directorate for the Quality of Medicines and the World Health Organisation. He was seconded to the UK Department of Health Solicitors Office dealing with policy and litigation matters. He led the UK delegation at the ICH on the topic of gene therapy and was the first chair of the EMEA’s Gene Therapy Expert Group and chaired the EMEA/CPMP Expert Group on drafting policy papers on matters relating to transmissible spongiform encephalopathy agents (TSE). He was Principal Assessor to the Committee on Safety of Medicines Biologicals Subcommittee as well as TSE Vaccine Expert Group appointed by the Public Health Minister to evaluate safety of UK licensed vaccines. He was a member of the MRC Steering Committee on Stem Cell Topics lectured Seminar 1:
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Dr. Karen van Graevenitz Buser, F. Hoffmann - La Roche 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. Resea Topics lectured Seminar 2:
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Dr. Connie van Oers holds a PhD in Physiological Chemistry from the University of Utrecht. She started her career as Project Leader at the Training Centre Medical Biotechnology of the Hogeschool West-Brabant. Before she started to work as Regulatory Affairs Executive at Roche Nederland B.V. she worked from 1994 to 1998 as Technical Services Manager at Promega Benelux B.V.. In 2003 she became Regulatory Affairs Manager, Drug Safety, QA at Roche Nederland B.V. where she stayed till 2010. Currently Dr. van Oers is working as Senior Consultant at Xendo Pharma Services B.V., Division Regulatory Affairs – Regulatory Affairs support. Topics lectured Seminar 2:
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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. Topics lectured Seminar 3:
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Dr. Heike Wachenhausen, Lützeler Klümper Wachenhausen Rechtsanwälte Dr. Heike Wachenhausen holds a PhD in law from University Göttingen. From 2000 to 2003 she worked as lawyer for the group “Healthcare, Life Sciences and Chemicals” at Clifford Chance in Düsseldorf. Afterwards she changed to the lawyer’s office Sträter. In 2009 Dr. Wachenhausen changed to Novartis Pharma AG in Basel where she worked as Head Legal Regulatory & Development. Since June 2011 Dr. Wachenhausen works for Lützeler Klümper Wachenhausen Rechtsanwälte. Topics lectured Seminar 8:
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Dr. Hans Joachim Wallny, Novartis Pharma AG Dr. Hans-Joachim Wallny is a Technical project leader at the departement „Process Sciences and Production“, Novartis Pharma AG Switzerland. He was leading the technical team who recently achieved the approval of a monoclonal antibody (ILARIS) for the treatment of a rare autoinflammatory disease (CAPS) in US, EU and Switzerland. Before this assignment he was head of a bioanalytics group, responsible for the development and validation of biological potency assays and high molecular impurity assays for bio¬pharmaceuticals during early development. Before he was head of the bioassay group, which included the responsibility for routine performance of bioassays for marketed products. One of his main scientific ambitions was to develop and implement modern, fast and reliable bioassays using early cellular events as read-outs (e.g. reporter gene assays, KIRA assays, etc.). For this he was honored with the title “Novartis Leading Scientist” in 2003. Prior to joining Novartis in 1997, he was a Lab head in the Biotechnology departement, Research and Development of Biotest Pharma GmbH, Germany, responsible for the development of bioanalytical methods and analytics for preclinical/clinical trials (1995-1997). Dr. Wallny was previously a Scientist at the Basel Institute for Immunology, Switzerland (1992-1995) after receiving his Ph.D. degree in Biochemistry/Immunology from the University of Tübingen, Germany. Dr. Wallny received a diploma in biochemistry from the University of Tübingen, Germany in 1989. Topics lectured Seminar 4.1:
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Dr. Andrew Warren, Novartis Pharma AG Andrew is a Director of Bioanalysis at Novartis, where he is responsible for the development, validation and implementation of preclinical and clinical PK, PD and immunogenicity assays. Prior to joining Novartis, Andrew was head of Clinical Immunology in the GlaxoSmithKline Biopharmaceuticals Unit, where he was responsible for clinical biomarker and clinical immunogenicity assays to support the biopharmaceuticals portfolio. Prior to this Andrew headed a clinical biomarker lab at GSK within the Translational Science and Genetics department.Earlier in his career Andrew worked in a number of academic institutes, at the University of London where he was a Wellcome Trust fellow working on lymphocyte activation, as a post-doctoral fellow at University of Texas working on lymphocyte development, as a lecturer at University of Wales, working on viral immunology and as a postdoctoral fellow at the UK National Institute for Medical Research, studying dynamic interactions between host immune response and virus infections. Andrew has a PhD in Biochemistry from the University of London. Topics lectured Immunogenicity Integrated - Interactive Workshop:
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John Warren is a clinical scientist who established Medicines Assessment Ltd as a pharmaceutical consultancy in 2011 (see medicinesassessment.com). Previously he worked for the UK Medicines Healthcare products Regulatory Agency (MHRA) as an Expert Medical Assessor from 1995-2010 evaluating new drug applications for the UK and Europe across the therapeutic spectrum. He was a member of the European Scientific Advice Working Party 2003-2010 and the European Pharmacokinetic Subgroup of the Efficacy Working Party 2007-2008. He contributed to the EU Notes for Guidance on Asthma, COPD, ARDS and Bioequivalence. When appointed to the MHRA in 1995 he took a concomitant five year Honorary Senior Lecturer post in Clinical Pharmacology at St Thomas' Hospital. Previous appointments include Senior Lecturer at the National Heart and Lung Institute, with Honorary Consultant status at the Brompton, Charing Cross and Chelsea & Westminster Hospitals, 1990-1994. This followed a Senior Registrar post in Clinical Pharmacology at the Royal Postgraduate Medical School 1986-1990. He holds triple specialist accreditation in the UK in General Medicine, Clinical Pharmacology and Cardiology. He is the author of over 100 publications in international journals on the physiology and pharmacology of the autonomic system and a book on the Endothelium. Topics lectured Seminar 4.2:
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Prof. Dr. Pascal Wehrle, University of Strasbourg Prof. Dr. Pascal Wehrle is a pharmacist and professor at the Faculty of Pharmacy of Strasbourg where he teaches pharmaceutical technology. He is graduated from the University of Paris and the University of Strasbourg. In his research and development activities dealing mainly with solid dosage forms he is studying and using mathematical and statistical multifactorial methods to rationalise pharmaceutical processes and drug formulations. Professor Pascal Wehrle is also President of the French Association of Academic Professors in Pharmaceutical Technology and Expert at the French Agency for the Safety of Medical Products (AFSSAPS). Topics lectured Seminar 4.1:
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Dr. Hannelore Willkommen, Regulatory Affairs & Biological Safety Consulting Dr. Hannelore Willkommen works as Consultant for Regulatory Affairs and Biological Safety of biopharmaceuticals. She is active in international organisations like PDA (Parenteral Drug Association) and she leads at present PDA’s Biotech Interest Group in Europe. Hannelore Willkommen worked for more than 25 years at the German regulatory agency, the Paul-Ehrlich Institute. In this capacity, she was responsible for the marketing authorisation and supervision of biological medicinal products and, as her special field, for the viral and TSE safety assessment of biopharmaceuticals in national and European license procedures. Dr. Willkommen played a leading role in drafting national and European guidelines on viral and TSE safety of biotech and blood products. Topics lectured Seminar 4.1:
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Dr. Erik Worsøe has held his current position as global head of regulatory affairs in Nycomed since 2001. He joined from the Danish Medicines Agency where he headed the Licensing Division in its early days as an independent agency under the Ministry of Health. The position also had the responsibility for coordination and planning of all the Agency’s activities vis a vis the EMEA and its scientific committees. A broad experience in all aspects of the regulatory affairs discipline stems from different positions in Sandoz (before merging into Novartis) and numerous international tasks during his carrier in public service (National Board of Health) with legal as well as regulatory areas. Erik has had substantial involvement in different working groups at EC Commission as well as Council WGs in the preparation of legislative framework for pharmaceutical in the EU. Erik was also one of the initiators of a broad postgraduate training course for regulatory affairs professionals in Denmark (now known as Medicadamy). Recent decade has been focusing on development strategies in drug development. Topics lectured Seminar 5:
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Dr. Manuel Zahn, 3R Pharma Consulting Dr. Zahn began to work in the pharmaceutical industry in Quality Control and Production (QP), and later in Regulatory Affairs in 1978. 2002 he joined AstraZeneca in Sweden as VP, Global Head of Regulatory CMC. In 2008 he formed the independent consultancy company 3R Pharma Consulting GmbH and one year later he became APIC Certified GMP Auditor. Dr. Zahn has been a member of the ICH Expert Working Group developing the ICH Stability Guidelines (1991-2003) and the ICH CTD Guideline M4-Q (1997-2001). From 2001 to 2005 Dr. Zahn represented the IFPMA when the ASEAN Stability Guideline has been developed.As a WHO Temporary Advisor, he has been involved in developing a regional stability guideline for the WHO Eastern Mediterranean Region as of 1993. A revised version of the guideline has been released in 2006. This document was then used as a draft for the new global WHO Stability Guideline released in 2009. Dr. Zahn is a member of the Steering Committee of the AAPS Stability Focus Group.Over 30 papers in journals and textbooks have been published since 1978, and presentations delivered at many international conferences and training courses since 1988. Since 1998, Dr. Zahn is an active member of the Editorial Board of ”Regulatory Affairs PHARMA”, and a member of the Advisory Board of Pharma iQ. Topics lectured Seminar 4.1:
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