Titel: The Implementation of the Clinical Trials Directive and the Evolving Role of European Ethics Committees

Beginn: 7.10.2003, 8:30 -17:00 Uhr

Veranstaltungsort:
Résidence Palace
Brussels, Belgium

Referenten: Roger Bickerstaffe (Chairman, European Forum for Good Clinical Practice) * Dominique Sprumont (European Forum for Good Clinical Practice) * Roman Lorenc (Ethics Committee, Child Health Center, Memorial Hospital, Warsaw, Poland) * Paul De Schepper (Ethical Review Committee, University of Leuven, Belgium) * Rudolf Burger (Bayerische Landesärztekammer Ethik-Kommission, Germany) * Christa Janko (Vienna School of Clinical Research, Austria) * Terry Stacey (Central Office for Research Ethics Committee, United Kingdom) * Imre Szebik (Semmelweis Medical University, Hungary) * Dirk Lanzerath (Deutsches Referenzzentrum für Ethik in den Biowissenschaften, University of Bonn, Germany) * Jozef Glasa (Slovak Postgraduate Academy of Science, The Slovak Republic) * Martin Walter (Association for Good Clinical Practice in Poland) * Monika Seibert-Grafe (University of Heidelberg, Germany) * Dominique Sprumont (European Forum for Good Clinical Practice) * François Chapuis (Conférence Nationale des Comités Consultatifs pour la Protection des Personnes en Recherche Biomédicale, France) * Francis P. Crawley (European Forum for Good Clinical Practice) * Tamás L. Paál (National Institute of Pharmacy, Hungary) * Marc Bogaert (Ethical Review Committee, University of Gent, Belgium) * Milan Smid (State Institute for Drug Control, Czech Republic) * Roger Bickerstaffe (Chairman, European Forum for Good Clinical Practice)

Kurzbeschreibung: With the implementation of the Directive 2001/20/EC and the related European Commission guidance documents for ethics committees, the national systems and procedures for ethical review in Europe are now in the process of being revised in nearly all European countries. All 'old' and 'new' European Union member states are in the process of reviewing their legislation and procedures for human subjects projections and the functioning of their ethics committees. This EFGCP Forum Discussion examines the effects of the expected impact on the ethical review of clinical trials.

The Forum Discussion has been prepared through discussions with regulatory authorities, members of ethics committees and their responsible authorities or organisations, investigators, and sponsors in a large number of the EU member states. These discussions demonstrated that there is a need to improve a European dimension to the development of ethical review within the member states. There is also a strong need to share experiences and understandings.

The European Forum for Good Clinical Practice (EFGCP) is an independent, not-for-profit organisation, that has worked closely with the European and member state institutions on the development of ethical review. The EFGCP has also played a leading role in the discussion on the Directive and the supporting guidance documents.

Kontakt: conferences@efgcp.org

Veranstalter: European Forum for Good Clinical Practice

Schlagworte: Ethik-Kommissionen