Thursday, 14 May 2009

08.30 Registration and welcome coffee

09.00 Introduction to the course
Marc Benijts

09.15 Pharmaceuticals - Definitions - Product life cycle
Ann Lampo

10.15 The European Union and its institutions
The Belgian bodies
Anne-Marie Georges

11.00 Coffee break

11.15 The role and the structure of the EMEA and the possible procedures
Anne-Marie Georges

12.15 Lunch

14.00 The pharmaceutical legislation (EU - B)
Peter Bogaert

15.15 Coffee break

15.30 Variations - Extensions - Renewals
Mia Dreessen

16.45 Pharmacovigilance
Michèle Sangeleer

18.00 End of the first session

Friday, 15 May 2009

09.00 Common Technical Dossier (CTD)
Intro & module 3
Bart De Spiegeleer

10.00 CTD module 4
Karen De Smet

11.00 Coffee break

11.15 CTD module 5
Pieter Neels

12.15 Lunch

14.00 CTD module 1 & eCTD
Anne Verhoye

15.30 Coffee break

15.45 Legislation for clinical trials
Kristof Bonnarens

16.45 Publicity - Mdeon Marc Van Grimbergen

17.45 Closing remarks
Marc Benijts

18.00 End of the Introductory Course
 

Attendance limited to 30 BRAS participants. Early registration and payment recommended.