Risk Management

“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