29.09.2015 - 13:30

Clinical Trial session 2015

Location : De Montil, Affligem

Fees : for BRAS Members 150€ - For non members 350€

Programme and Speakers 

13:30     Introduction : clinical trials 2004 – 2015
             Kristof Bonnarens - FAMHP

14:00     Clinical trial Regulation : EU level
             - Overview of the changes
               Isabelle Vrancken - Antwerp University
             - Overview of the implementation on EU level (EU Portal)
               Kristof Bonnarens - FAMHP

 15:00     Coffee break

 15:30     Clinical trial Regulation : implementation in Belgium
              - Practical organisation in Belgium from the national competent                             authority point of view
                Anne Lenaers & Caroline Van Droogenbroeck - FAMHP R&D 

              - Practical organisation in Belgium from an ethics committee point of                     view
                Georges Niset - Ethics committee
              - Impact on GMP and GCP inspections
                (when feasible by DG inspection representative)

16:30      Selected topics on early phase (objectives, transparency policy)
              Walter Janssen - FAMHP

17:00     Q&A

17:15     Closure

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 21 September 2015, the fees are due and will be invoiced. 

Registration on BRAS website only (www.bras-org.be).  If any assistance is needed please contact Brigitte at bras@bras-org.be of call her on 02/757.06.29.