Risk Management Plans and Risk Minimization Activities: An update!

Date: 28 May 2013
Location: De Montil, Affligem

Programme:

13h30 Introduction
Dimitry Christiaens, BRAS Education Group
Hugues Haesebroek, BRAS Education Group

13h40 Risk Management Plan: (English)
The PRAC – An overall overview
What’s the role of the PRAC in the evaluation of RMPs?
RMP Effectiveness: What does it mean and how is it evaluated?
Examples based on PRAC Minutes
Prof. Jean-Michel Dogné, FUNDP and FAMHP Representant at the PRAC

14h40 From Risk Management Plan to Risk Minimization Activities: (French)
New Royal Decree: Status and General Explanation
Role of the Pharmacovigilance Department in RMP/RMA handling
Thierry Roisin, FAMHP

15h10 Coffee Break

15h30 Risk Minimization Activities: (French)
New Royal Decree: Impact on the process for review and approval of RMAs
Marie-Louise Bouffioux, FAMHP

15h50 Risk Minimization Activities: (French)
Process flow within department “Proper Use of Medicines”
Experience from the last years
Statistics
Best Practice for compiling your risk minimization activity plan
Marie-Louise Bouffioux, FAMHP

16h30 Questions & Answers

17h00 End of the session
Dimitry Christiaens, BRAS Education Group
Hugues Haesebroek, BRAS Education Group

Fees : 150€ for a member & 350€ for a non member.

It is understood, to be admitted to the session, that the fees have been pre-paid.
In case of cancellation after 17 May 2013, the fees are due and will be invoiced.