NEW DATE FOR THIS SESSION: Tuesday 15 May 2012 at 13:30

Location : De Montil, Affligem

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

Programme and Speakers

13.30 Session introduction
Annabelle Bruyndonckx or Noëlla Heyman or, Dimitry Christiaens, BRAS Education Group

13.35 Agency Introduction
Vanessa Binamé, FAGG-AFMPS
• Priorities of the EMA.
• Implementation in the Belgian legislation: amendments to the Law of 25 March 1964 and to the Royal Decree of 14 December 2006.
• New fees (Law of 24 February 2012).

13.50 Implementation of Directive 2010/84/EU and Regulation (EU) 1235/2010
(Thierry Roisin, FAGG-AFMPS)
• Summary of main changes
• PRAC, urgent union procedure, new obligations regarding transparency and communications

14.15 Pharmacovigilance System Master File – QPPV – Audit
Nele Matthijs, FAGG-AFMPS

14.45 Risk Management Plan (RMP), Post Authorization Safety Study (PASS), Post Authorization Efficacy Study (PAES)
Jamila Hamdani, FAGG-AFMPS

15.15 Coffee Break

15.40 Individual Case Safety Reports (new definition of adverse reaction, reporting rules) Margriet Gabriëls, FAGG-AFMPS

16.00 PSURs & Renewals
Sophie Goethals, FAGG-AFMPS

16.30 Panel Discussion - Questions & Answers

17.00 Closing
Annabelle Bruyndonckx or Noëlla Heyman or Dimitry Christiaens, BRAS Education Group

Language for this session: Dutch/French - slides in English