Introduction to Regulatory Affairs 2015



11th edition 7 & 8 May 2015

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 program proposes an introduction to the legal, scientific, organizational and administrative aspects of medical products given by 13 experienced tutors from university, FAMHP and industry.

Program and speaker 

Day 1


08.30 Registration and coffee

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

09.15 Pharmaceuticals – definitions – product life cycle
            Ann Lampo (Janssen Research and Development)

10.15 The European Union and its institutions – The Belgian bodies
            Peter Bogaert & Charlotte Ryckman (Covington & Burling LLP)

11.00 Coffee Break

11.30 The pharmaceutical legislation (EU – B)
            Peter Bogaert & Charlotte Ryckman (Covington & Burling LLP) 

12.30 Lunch

13.30 European Medicines Agency – EU procedures for Marketing Authorisations
            Ingrid Theeuwes (PhaRa consulting)

15.00 Coffee Break

15.30 Legislation for clinical trials
            Kristof Bonnarens (FAMHP)

16.30 Mdeon – art. 10
            Stéphanie Brillon  (Mdeon)

17.15 End of the first day

Day 2

09.00 Pharmacovigilance
            Michèle Sangeleer (Eli Lilly)

10.15 Coffee Break

10.45 Intro to CTD & module 3
            De Spiegeleer Bart (Ugent)

11.45 CTD module 4
            Karen De Smet (FAMHP)

12.45 Lunch 

13.45 CTD module 5
           Nele Steens (FAMHP)

14.45 Variations – renewals – extensions
           Claudia Stecca (Merck Sharp & Dohme Europe)

16.00 Coffee Break

16.15 Marketing Authorisation – Legal basis – Practical aspects linked to module 1
           Katelijne Van Keymeulen & Machteld Verbruggen (FAMHP)

17.15 Closing remarks
            Marc Benijts (BRAS)

17.30 End of the course

Alphabetic list of speakers

Peter Bogaert, Lawyer Covington & Burling LLP

Kristof Bonnarens, Head of Division R&D, DG PRE Authorisation, Federal Agency for Medicines and Health Products

Stéphanie Brillon , Directeur Mdeon asbl-vzw

Karen De Smet, Non-clinical Assessor, DG PRE Authorisation, Federal Agency for Medicines and Health Products

De Spiegeleer Bart ,Professor, DruQuaR (Drug Quality & Registration) group, Dept. Pharmaceutical Analysis, Faculty Pharmaceutical Sciences, Ghent University

Anne Lampo, Senior Director Preclinical Project Development, Janssen Research and Development

Ryckman Charlotte, Lawyer Covington & Burling LLP

Michèle Sangeleer, MD, FFPM, Medical Information and Drug Safety Manager, Eli Lilly, Belgium

Claudia Stecca, Director Regulatory Affairs – Europe, Merck Sharp & Dohme (Europe) Inc.

Nele Steens, Clinical Assessor, DG PRE Authorisation – Division Evaluators, Federal Agency for Medicines and Health Products

Ingrid Theeuwes, Consultant PhaRa

Katelijne Van Keymeulen, Dossier Administrator, DG PRE Authorisation – Department MA, Federal Agency for Medicines and Health Products

Machteld Verbruggen, Dossier Administrator, DG POST Authorisation – Department MA Dispatching, Federal Agency for Medicines and Health Products

BRAS Member = 900€ - Non Member = 1.100€

It is understood to be admitted to the course that the fees have been prepaid.
In case of cancellation after 29 April 2015 the fees are due and will be invoiced.