Introduction to Regulatory Affairs

23 & 24 May 2013 - Introduction to Regulatory Affairs

Venue: AFMPS / FAGG – Eurostation II – Place Victor Hortaplein 40, 1060 Brussels

The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation ; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

The programme proposes an introduction to the legal, scientific, organisational and administrative aspects of medical products given by experienced tutors from university, FAMHP and industry.

Thursday, 23 May 2013

08.30 Registration and coffee

09.00 Welcome & introduction to the course
Marc Benijts (BRAS)

09.15 Pharmaceuticals – definitions – product life cycle
Ann Lampo

10.15 European Medicines Agency – EU proce- dures for Marketing Authorisations  
           part 1

Ingrid Theeuwes

11.00 Coffee break

11.15 EU procedures for Marketing Authorisations part 2
Ingrid Theeuwes

12.00 Lunch

13.30 The European Union and its institutions – The Belgian bodies
Peter Bogaert & Sarah Forest

14.00 The pharmaceutical legislation (EU – B)
Peter Bogaert & Sarah Forest

15.00 Coffee break

15.15 Legislation for clinical trials
Kristof Bonnarens

16.15 Pharmacovigilance
Heidi Schwer

17.30 End of first day

Friday, 24 May 2013

09.00 Publicity – Mdeon
Stéphanie Brillon

10.00 Intro to CTD & module 3
Bart De Spiegeleer

11.00 Coffee break

11.15 CTD module 4
Karen De Smet

12.15 Lunch

13.15 CTD module 5
Pieter Neels

14.15 Variations – renewals – extensions
Claudia Stecca

15.30 Coffee break

15.45 Marketing Authorisation – Legal basis – Practical aspects linked to module 1
Katelijne Van Keymeulen & Machteld Verbruggen

17.15 Closing remarks
Marc Benijts (BRAS)

17.30 End of course

Presentations will be given in English.

Be aware that the course is intended for a LIMITED NUMBER OF PARTICIPANTS ensuring an optimal learning process.

Cancellations will neither be accepted nor reimbursed after 8 May 2013. Before that date 20% will be retained for administrative costs.

Further practical information can be obtained through the BRAS secretariat, Mrs Brigitte Frenay tel +32 2 757 06 29 or e-mail

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