Clinical Trials: R&D within the Federal Agency of Medicines and Health Care products in Belgium.

Date: Thursday September 6, 2012 afternoon session

Time: 13h30 till 17.00 - we will start on time with a welcome coffee as of 13h

Location : De Montil, Affligem

Fees : BRAS members = 150€ / Non members = 350€

Mrs Greet Mush, Mr Kristof Bonnarens and their team will inform us about the European and national activities and several interesting new items for the research and development of the drugs.

13h30 Welcome to the participants and introduction of the session
Agnes Degroote and/or Marian Coquel, BRAS Education Working Party

13h35 Overview on the updated European clinical trial legislation (single portal, CAP/VHP, co-sponsorship…)
Greet Musch, Director-General DGPRE - FAMHP

14h20 National implementation of updated CTA regulation (CT3, VHP, CTFG Q&A, IMP/nIMP, interactive website) and other national concepts (DSUR, law on experiments, early access, fees…)
Kristof Bonnarens, Head of Division R&D DG PRE Authorisation - FAMHP

15h05 Coffee Break

15h35 GMP for clinical trials (current circular letter)
Walter Janssens, Senior Preclinical Assesson, Preauthorisation
Coordinator Early Phase Development - FAMHP

16h00 EudraCT8 user driven feedback
Katja Lammens, Regulatory Affairs Specialist - PPD

16h30 Questions & Answers

17h00 Closing of the session
Agnes Degroote and/or Marian Coquel, BRAS Education Working Party