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Programme Overview

The themes for the EuroMeeting 2013 include the professional disciplines of regulatory affairs, safety and efficacy for human medicines, diagnostics and devices. Much innovation will be fostered by interaction between disciplines and jointly between the stakeholders of healthcare innovation such as industry professionals, academia, regulatory competent authorities, patient representatives, and the general public.

Theme 1 | Health Technology Assessment (HTA)/Sustainability of Health Systems in Europe
Luca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy
Lidia Retkowska-Mika, Head Legal Unit, Office for Registration of Medicinal Products, Poland

Theme 2 | Development of Medicinal Products for Paediatric, Elderly and other Special Populations
Gesine Bejeuhr, Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany
Markus Pasterk, COO and VP of Science, International Prevention Research Institute, France

Theme 3 | Legal/Transparency/Risk & Litigation
Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany

Theme 4 | Pharmacovigilance
Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK
Jan Petracek, CEO, Director of Pharmacovigilance Services, Pharminvent, Czech Republic

Theme 5 | Clinical Research and Development
Andrei Kravchenko, Head of Office, Harrison Clinical Research, Ukraine
Nermeen Varawalla, Founder and CEO, ECCRO, UK

Theme 6 | Quality (including Falsified Medicines)
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

Theme 7 | Devices & In Vitro Diagnostics and Combination Products
Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Scientific Communication, Switzerland
Siniša Tomić, Counselor for European Affairs, Agency for Medicinal Products and Medical Devices, Croatia

Theme 8 | eHealth
Hans van Bruggen, Director, eCTDConsultancy, Netherlands
Rob Middel, Head of R&D Business Development, Pharmaceutical R&D Quality & Compliance, Senior Director Janssen Biologics, Netherlands

Theme 9 | Involvement of Patients and Academia as Experts in the Drug Approval Process
Gonzalo Calvo Rojas, President of the European Association for Clinical Pharmacology and Therapeutics (EACPT), Spain
Judith Creba, Head EU Liaison & Policy, Novartis, Switzerland

Theme 10 | Known Active Substances
Maren von Fritschen, Director Regulatory Affairs, PharmaLex, Germany
Marta Marcelino , Member CMDh, Medicines Evaluation Department, National Authority of Medicines and Health Products (INFARMED), Portugal

Theme 11 | Antiobiotics/Anti-Infective Treatments
Richard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

Theme 12 | Effectiveness and Efficiency of the EU Regulatory system - Does new legislation enable innovation and facilitate co-operation?
Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer Healthcare Pharmaceuticals, Germany
Melek Bostanci Önol, Head of Regulatory Affairs & Quality Assurance, Boehringer Ingelheim, Turkey

Theme 13 | Globalisation
Christer Backman, Member CMDh, EU Coordinator and Senior Expert, Medical Products Agency, Sweden
Ning Xu, Executive Director, Head of CDS, Covance Pharmaceutical R & D, China

Theme 14 | Regulatory Science
Christine Gispen-De Wied, Clinical Coordinator; Member of SAWP, Medicines Evaluation Board (MEB), Netherlands
Hubert Leufkens, Chairman, Medicines Evaluation Board (MEB), Netherlands

Theme 15 | Growing Demand for Quantitative Approaches in Drug Development
Jürgen Kübler, Global Head, Clinical Sciences, CSL Behring, Germany
Steven Teerenstra, Statistical Evaluator, Medicines Evaluation Board, Biostatistics Working Party (BSWP), Netherlands

Theme 16 | Non-Clinical
Jan Willem van der Laan, Senior Pharmacological Toxicological Assessor, Medicines Evaluation Board (MEB), Netherlands

Theme 17 | The IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
Hans Lindén, Leader European Projects , European Federation for Pharmaceutical Sciences (EUFEPS), Sweden



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