Session on Clinical Trials - Practical aspects - 24.09.2013

Location: De Montil, Affligem

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

Agenda

13:30 Regulatory overview: current situation
EU regulation and legislation: new points BE legislation: circular letters; revision of the Belgian law on experiments; ethics committees
Kristof Bonnarens, FAMHP

14:15 Safety in clinical trials
Safety legislation; RSI/DSUR reporting ; Eudravigilance ; + figures with regard to the reporting and link to clinical trials applications
Erik Everaert, FAMHP

14:45 Early phase development
Experience with exploratory clinical trials in Belgium.
Walter Janssens, FAMHP

15:15 Coffee Break

15:45 DG Inspection: status on het inspections and new GMP circular letter
Karin Froidbise, FAMHP

16:05 Studies with radio-active substances studies: what is ongoing and current status of the situation
Karin Froidbise, FAMHP

16:30 Q&A

Also, this session is a good opportunity to ask questions to the FAMHP: you can forward us your general questions or specific cases and we will submit these anonymously to the FAMHP. Due date for submitting questions to bras@bras-org.be is 13 September 2013.

Language for this session : English.