14h00 Mammoth Royal Decree : Title V
Pharmacovigilance for human use
art. 66 until 73, 134, 191 until 200,
268, incl. renewal (art. 37-172-265)
Speaker : Thierry Roisin

Circular letter nr 476 - 1,5 month experience
with PSUR electronic submissions: what works
well, what can be improved...
Speaker : Katrien Bernaert

Draft Circular letter - will be issued in April
2007 - concerning last renewal and PSUR
cycle - practical aspects
Speaker : Suzanne Massonnet

Questions & Answers

16h00 Coffee Break

16h30 New edition Eudralex volume 9A
Pharmacovigilance for human use (January
2007) - What are the main changes?
Speaker : Jean Schlusselberg

Mammoth Royal Decree Annex III electronic
reporting

Eudravigilance in near future
Speaker : Margriet Gabriels

Questions & Answers