“Risk Management”
Location: De Montil, Affligem
26.05.2011

13h30 Introduction
Rembert Van de Sande, BRAS Education Group
Hugues Haesebroek, BRAS Education Group

13h40 Risk Management Plan
Overview of EMAs risk management requirements
The major goals of risk management
Best practices for compiling your risk management plan
Jamila Hamdani, FAMHP
Prof. Jean-Michel Dogné, FUNDP and FAMHP Representant at the Ph. Working Party

Questions & Answers

14h40 Coffee Break

15h00 Risk Minimization Activities
Legal Requirements at national level
Best Practice for compiling your risk minimization activity plan
Marie-Louise Bouffioux, FAMHP
Jan Meskens, FAMHP

Questions & Answer

16h00 Understanding the benefits, impact and consequences of an EU RMP
Industry Perspective on Risk Management Plans
Gert De Beckker, Tigenix

16h30 Pharmaceutical Package and Risk Management Plans:
Upcoming Legal basis
Evaluation of efficacy of Risk Management Plans
Sophie Goethals, FAMHP

Questions & Answers

17h00 End of the session
Rembert Van de Sande, BRAS Education Group
Hugues Haesebroek, BRAS Education Group