Date: Thursday 6 and Friday 7 March 2008

Venue : UAE - La Maison
Campus de la Plaine
Bd du Triomphe - 1050 Brussels
Entrance 4
(near to the Fire Brigade
Metro station Delta)

Timing: 08.30 Welcome
09.00 Start of the sessions

Speakers: See programme here under


For both BRAS-members and non-members.



For conditions and registration, please contact Brigitte Frenay at BRAS administrative Office by phone: 02/757.06.29, Fax: 02/759.36.94 or e-mail at bras@bras-org.be


Warning: as all the persons on last year waiting list are contacted first and attendance is limited to max. 30 persons, your early registration and payment are highly recommended.


This event is placed on our website but there will be no further mailing sent.


Thursday, 6 March 2008

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

12.30 Lunch

13.30 The pharmaceutical legislation (EU - B) Peter Bogaert & David Van Passel

15.00 Coffee break

15.30 Variations - Extensions - Renewals
Mia Dreessen

16.30 Pharmacovigilance Mich?le Sangeleer

18.00 End of the first session & drinks



Friday, 7 March 2008

09.00 Common Technical Dossier (CTD)
Intro & module 3
Yvette Michotte

10.00 CTD module 4 Karen De Smet

11.00 Coffee break

11.15 CTD module 5
Bruno De Schuiteneer

12.15 Lunch

13.30 CTD module 1 & eCTD
Anne Verhoye

15.00 Coffee break

15.15 Legislation for clinical trials Kristof Bonnarens

16.15 Publicity - Mdeon Marc Van Grimbergen

17.15 Closing remarks
Marc Benijts

17.30 End of the Introductory Course