Organisation
Scientific Course Committee
The Scientific Course Committee constantly evaluates the course programme in its practical relevance. The Scientific Course Committee
- appoints the Study Director and the members of the Admission and Examination Committee
- adopts the study regulations, the guideline on the entry requirements and the examination regulations of the course.
The Scientific Course Committee is composed of representatives of health authorities, the University of Freiburg, the University of Strasbourg, and of pharmaceutical companies. The members of the Scientific Course Committee are involved in the course as speakers.
Chairman
Prof. Dr. Andreas Bechthold, University of Freiburg
Director of Department Pharmaceutical Biology and Biotechnology
Andreas.Bechthold@pharmazie.uni-freiburg.de
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.
Members
Dr. Stephane Andre, F. Hoffmann - La Roche Ltd.
Site Head - Pharmaceutical Division - Pharma Development Regulatory
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.
Dr. Gabriele Dallmann, EUCRAF Ltd.
Study Director
For more information, please see > Study director
Dr. Axel Glatz, Pfizer Manufacturing Deutschland GmbH
Site Leader - Manufacturing Director
Dr. Axel Glatz began his carrier with Pfizer in 1994 as Head of Quality Operations at Freiburg. Prior to being appointed Site Leader in December 2009, he was SiteTransformation Leader for the Freiburg, Germany site. He became member of the Warner Lambert Global Quality Operations Leadership Team in 1997. In September 2004, Dr. Glatz undertook the role as Director Quality Projects, at the Puurs, Belgium site. In October 2005, he became the Site Leader and General Manger of the Feucht, Germany site until its divesture from Pfizer in December 2007.
Dr. Glatz holds a diploma in Chemistry and Pharmacy and a Ph.D. in PharmBiology from the University of Saarbrücken, Gemany.
Prof. Christiane Heitz, University of Strasbourg
Study Director - MSc Medicinal Products, Faculty of Pharmacy
christiane.heitz@pharma.u-strasbg.fr
Christiane Heitz is a pharmacist and professor in pharmacology and clinical pharmacy at the Faculty of Pharmacy of Strasbourg. She was Vice-Dean of the Faculty of Pharmacy of Strasbourg from 1990 and 1999, Dean of the Faculty of Pharmacy of Strasbourg from 1999 to 2002, Vice Rector in charge of the pre- and post-graduate studies of the University of Strasbourg from 2002 to 2007 and coordinator of Vice Rectors network at a national scale from 2005 to 2007.
Since September 2007, she has been managing the Masters of Drug Sciences of the University of Strasbourg. She has been nominated Expert of Bologna in May 2007, expert for the AERES (french accreditation commission) in September 2007 and Member of the Accreditation Commission of Swiss Health Studies in 2006.
As a member of the Ethical Committee of the Faculty of Medicine, Pharmacy and Dentistry of the University of Strasbourg and since 1991 of the Committee of Individual Protection, she has gained expertise in evaluating clinical research projects.
She has showed a strong engagement for studies set-up and university pedagogy during her whole career. She has had the responsibility of setting-up the University Louis Pasteur education program according to the Bologna process in the Licence-Master-Doctorate configuration.
Dr. Susanne Keitel, EDQM
Director
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.
Prof. Jean-Yves Pabst, University Strasbourg
Dean Faculty of Pharmacy
doyen.pharma@adm-ulp.u-strasbg.fr
Jean-Yves Pabst is a pharmacist and professor in pharmaceutical law and economics. Since 2007 he is the dean of the Faculty of Pharmacy of the Universtity Strasbourg. Since then, he has been committed in the organization of partnerships with other Universities of the region in order to ensure the complementarity of both initial training and life-long learning.
In 2005 he established the major subject “European law and regulatory affairs” for the Masters degree in Drug Science with the active support of the Strasbourg Law Faculty and the European Directorate for the Quality of Medicines.
Jean-Yves Pabst has over 18 years experience as a pharmacist in regulatory affairs in the pharmaceutical industry.
Dr. Maria Pascual, Cellerix SA
Regulatory Affairs and Institutional Relations Director
Dr. María Pascual is Director of Regulatory Affairs at Cellerix, a biopharmaceutical company that develops and produces innovative medicines based on cell therapy. Dr. Pascual has an intensive research career behind her in the Spanish National Research Council (Consejo Superior de Investigaciones Científicas-CSIC) and is a past winner of the international Julia Bodmer Award. Her international experience includes work at the Mayo Clinic, in the US, and at the Leiden University Medical Center, in the Netherlands. She has experience in different positions in the area of regulatory affairs. As a recognized specialist in the field of drug development and regulatory affairs for advanced therapies, Dr. Pascual is an active participant in several technical working groups, she routinely lobbies for the European advanced therapies industry and is currently an expert consultant in this field for the European Medicines Agency (EMEA). Dr. Pascual graduated with a degree in pharmacy from the University of Granada, and later obtained her PhD in Pharmacy from the CSIC. She also holds a master’s degree in Regulatory Affairs from the Universidad Autónoma de Barcelona.
Dr. Silvia Pfaff, Novartis Pharma AG
Global Therapeutic Area Lead Immunology, Drug Regulatory Affairs Integrated Hospital Care (IHC)
Dr. Silvia Pfaff is Drug Regulatory Affairs Head for the Business Franchise Immunology and Infectious Diseases at Novartis in Basel, Switzerland. Prior to joining Novartis in July 2007 she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany. She has got almost 20 years of regulatory experience in positions with increasing responsibility at Sanofi, Boehringer Mannheim, Knoll, Abbott and Novartis with a focus on biologics over the past 15 years. She has a proven track record of successful submissions of global products in Europe, the US and Japan and achieving approvals with highly competitive labels. Dr. Pfaff trained as pharmacist at the University of Heidelberg and earned her Ph.D from the Technical University in Munich.
Dr. Monika Pietrek, Pietrek Associates GmbH
Managing Director
monika.pietrek@pietrekassociates.com
Dr. Monika M. Pietrek is a medical doctor and epidemiologist. Having worked in clinical care, pharmaceutical and CRO industries and at a regulatory agency, she has a broad based experience in international health care with specific expertise in clinical development, drug safety and risk management. In addition, Dr. Pietrek has gained substantial knowledge in process design/analysis and quality management.
During the past 20 years she has held senior positions at Behringwerke, the Paul-Ehrlich-Institut, Hoffmann-La Roche and PRA International, managing staff and projects across continents. Since 2009 Dr. Pietrek and colleagues provide their services to the pharmaceutical, biotechnology and medical device industry through Pietrek Associates GmbH, an independent consultancy firm.
Dr. Pietrek has served as DIA volunteer for more than 17 years, as a speaker, session chair, theme leader and as a member of various programme committees for the annual conferences and workshops in North America and Europe, the Continuous Medical Education Committee and the Advisory Council Europe. At present she is a member of the Professional Education, Training and Development SIAC and the Editorial Board of the DIA Journal as well as of the programme committee of the Clinical Forum 2011.
For more than 12 years Dr. Pietrek has been co-chairing a European PV expert group who focuses on operational aspects of drug safety and risk management. She has also been contributing to various initiatives led by ISPE, EFGCP, 7th MISG New Technology Forum and has been a regular speaker at international conferences.
Dr. Christian K. Schneider, Danish Medicines Agency
Senior Medical Officer
Christian K. Schneider, MD, is Senior Medical Officer at the Danish Medicines Agency. He is currently on a leave from the Paul-Ehrlich-Institut, the German Federal Agency for Sera and Vaccines, where he has been working as Director and Professor and Head of Division “EU Co-operation/Microbiology”. He is the chairman of the EMA’s Committee for Advanced Therapies (CAT), which started its work in January 2009. Between 2007 and 2011 he was co-opted member of the CHMP, the Committee for Medicinal Products for Human Use at the European Medicines Agency EMA, for the area of “Quality and safety (biological), with expertise in Advanced Therapies – Gene, Cell and Tissue Therapies”. He is chairman of the CHMP Working Party on Similar Biological Medicinal Products (BMWP) and was previously member of the CHMP Scientific Advice Working Party (SAWP). He has been actively involved in the drafting of several multidisciplinary guidelines, including the CHMP Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (the former “high-risk products guideline”), the CHMP Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues, and CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins for which he acts as Rapporteur.
Before he joined the Paul-Ehrlich Institut, Christian K. Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Department of Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiplesclerosis. During his clinical career, Christian K. Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany
Dr. Gertrud Thormann-Huber, The HST Consulting Network GmbH
CEO
gertrud.thormann@hst-online.com
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 Basel where she has a track record of successful approvals of several submitted MAAs for recombinant proteins and in her last position she was a senior member of the global regulatory management team.
Gertrud Thormann-Huber has a Degree in Pharmacy and PhD in Natural Sciences with specialization in pharmaceutical biology from University Munich.
Dr. Armin Weidmann, MorphoSys AG
Senior Director - Head of Quality Assurance/Regulatory AffairsDr. Weidmann joined MorphoSys AG in 2002. Since then he had held various positions with increasing responsibility. In is current position as Head of Quality Assurance & Regulatory Affairs he is responsible for all aspects of Drug Regulatory Affairs activities in the context of MorphoSys AG’s own development programs as well for the in house quality management system to ensure compliance with national and international regulations and guidelines. Dr. Weidmann has further experience in generation, characterization, and expression/purification of therapeutic antibodies.
Before joining MorphoSys Dr. Armin Weidmann did his post-doctoral training at the Department of Microbiology and Immunology of the Emory University in Atlanta, GA, USA on molecular virology studying the role of different viral proteins in the pathogenesis of HIV and SIV. He received his PhD in Biochemistry at the University of Würzburg, Germany focusing on the interaction of viral glycoproteins with lympho- and monocytic cells.
Dr. Erik Worsoe, Takeda
Vice President Regulatory Affairs
Erik Worsøe has held his current position as Global Head of Regulatory Affairs at Takeda (previously Nycomed) since 2001. He joined from the Danish Medicines Agency where he headed the Licensing Division in the 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 stemms 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 legaslative 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.