2 days Introduction to Regulatory Affairs

Date : 3 & 4 May 2012

Location : Federal Agency for Medicines and Healthcare Products

Thursday, 3 May 2012

08.30 Registration and welcome coffee

09.00 Introduction to the course
Marc Benijts

09.15 Pharmaceuticals - Definitions - Product life cycle
Anne Lampo

10.15 The European Union and its institutions
The Belgian bodies
Peter Bogaert

11.00 Coffee break

11.15 The pharmaceutical legislation (EU - B)
Peter Bogaert

12.15 Lunch

13.30 European Medicines Agency - EU
procedures for Marketing Authorisations
Ingrid Theeuwes

15.00 Coffee break

15.15 Legislation for clinical trials
Kristof Bonnarens
16.15 Common Technical Document - Mod 1
Sofie Colyn & Machteld Verbruggen

17.45 End of the first session

Friday, 4 May 2012

09.00 Publicity - Mdeon
Mieke Goossens

10.00 Introduction to CTD & Module 3
Bart De Spiegeleer

11.00 Coffee break

11.15 CTD module 4
Karen De Smet

12.15 Lunch

13.30 CTD Module 5
Pieter Neels

14.30 Coffee break

14.45 Variations - Extensions - Renewals
Claudia Stecca

16.00 Pharmacovigilance
Michèle Sangeleer

17.15 Closing remarks
Marc Benijts

17.30 End of the Introductory Course

Fees : 900€ for BRAS Members and 1.100€ for non Members

Maximum 30 seats