Programme Co-Chairs

Peter Bachmann, Senior Expert, European Drug and International Affairs, BfArM, Germany

Beatriz Vicén Banzo, Head of Regulatory Affairs, Bayer Hispania, S.L., Spain

Programme Committee

Christer Backman, EU Coordinator and Senior Expert, Medical Products Agency, Sweden

Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany

Melek Bostanci Önol, Head of Regulatory Affairs & Quality Assurance, Boehringer Ingelheim, Turkey

Fritz Bühler, IMI Pharmatrain, European Center of Pharmaceutical Medicine, ECPM Executive Office, University of Basel, Switzerland

Gonzalo Calvo Rojas, President of the European Association for Clinical Pharmacology and Therapeutics (EACPT), Spain

Norbert Clemens, Managing Director, Head of Clinical Development, CRS Mannheim, Germany

Judith Creba, Head EU Liaison & Policy, Novartis, Switzerland

Luca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy

Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK

Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Scientific Communication, Switzerland

Christine Gispen-De Wied, Clinical Coordinator; Member of Scientific Advice Working Party (SAWP), Medicines Evaluation Board, Netherlands

Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), Council of Europe, EU

John Kerridge, Quality Leader, EU QA External Relations, Lilly, France

Andrei Kravchenko, Head of Office, Harrison Clinical Research, Ukraine

Jürgen Kübler, Global Head, Clinical Sciences, CSL Behring, Germany

Hubert Leufkens, Chairman, Medicines Evaluation Board (MEB), Netherlands

Hans Lindén, Leader European Projects , European Federation for Pharmaceutical Sciences (EUFEPS), Sweden

Marta Marcelino, Member CMDh, Medicines Evaluation Department, National Authority of Medicines and Health Products (INFARMED), Portugal

Rob Middel, Head of Operations, Director, Quality Management Center of Excellence, Global Development Organisation, Janssen Biologics, Netherlands

Markus Pasterk, COO and VP of Science, International Prevention Research Institute, France

Jan Petracek, CEO, Director of Pharmacovigilance Services, Pharminvent, Czech Republic

Lidia Retkowska-Mika, Head Legal Unit, Office for Registration of Medicinal Products, Poland

Marc Sprenger, Director, European Centre for Disease Prevention and Control (ECDC), Sweden (Invited, TBC)

Isabelle Stöckert, Head Global Regulatory Affairs EU/CAN, Bayer Pharma AG, Germany

Burkhard Straeter, Lawyer, Kanzlei Straeter, Germany

Steven Teerenstra, Statistical Evaluator, Medicines Evaluation Board, Biostatistics Working Party (BSWP), Netherland

Siniša Tomić, Counsellor for European Affairs, Agency for Medicinal Products and Medical Devices, Croati

Hans van Bruggen, Director, Electronic Common Technical Document (eCTD) Consultancy, Netherlands

Jan Willem van der Laan, Senior Pharmacological Toxicological Assessor, Medicines Evaluation Board (MEB), Netherlands

Nermeen Varawalla, Founder and CEO, ECCRO, UK

Maren von Fritschen, Director Regulatory Affairs, PharmaLex, Germany

Ning Xu, Executive Director, Head of CDS, Covance Pharmaceutical R & D, China

Advisors

Angelika Joos, Director, Head Regulatory Policy, EU & Most of World, Merck Sharp & Dohme (Europe) Inc., Belgium

Aginus A.W. Kalis, Chair, Head of Medicines Agencies (HMA) Management Group; Executive Director, Medicines Evaluation Board (MEB), The Netherlands