Clinical Trials - Practical aspects

Session on Clinical Trials - Practical aspects - 24.09.2013

Location: De Montil, Affligem

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



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 is 13 September 2013.

Language for this session : English.

Share with others