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European Town Hall: Part 2 of 2 - Interacting With the European System
Program Code:
148
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of Licensing of Med Products and Deputy Head of the Austrian
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PRESENTER
(S):
Agnès Saint-Raymond, European Medicines Agency, European Union, United Kingdom
Xavier De Cuyper, Federal Agency For Medicines and Health Products (FAMHP), Belgium
Peter Bachmann,
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Peter Bachmann has joint in 1999 the Federal Institute for Drugs and Medical Devices (BfArM, Germany), Department of ‚Drug Approval‘. Following the reorganisation of the BfArM in July 2005, Peter Bachmann was appointed as Senior Expert for ‘European Drug Regulatory Affairs’ at Department ‘European a
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Description
Part 1 of this forum will take place on Monday, June 25 at 10:00am The European medicines system offers different ways of bringing new medicines to the patient, whether through the European Medicines Agency centralized route or through the European national agencies' decentralized route. This second part of the European Town Hall offers insights on the different initiatives and entry points to facilitate regulatory procedures and scientific dialogue from early development to post-marketing authorization stages. The forum offers the opportunity to interact directly with a panel of staff from the European Medicines Agency and European national agencies. Submit questions in advance to annualmeetingprogram@diahome.org Subject: European Town Hall
Learning Objectives:
Discuss how to navigate within the European Medicines Agency centralized procedures and European national agency procedures
Discuss how to use the various regulatory pathways that have been developed according to the type of products developed or the size of the company.