Introduction to Regulatory Affairs - 2014


10th edition May 22-23, 2014

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 speakers

Day 1

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 & Sarah Forest (Covington & Burling LLP)

11.00 coffee break

11.15 The pharmaceutical legislation (EU – B)
Peter Bogaert & Sarah Forest (Covington & Burling LLP)

12.15 Lunch

13.30 Publicity – Mdeon
Degroote Agnes (ADg Consultancy)

14.30 coffee break

14.45 Legislation for clinical trials
Kristof Bonnarens (FAMHP)

15.45 Pharmacovigilance
Michèle Sangeleer (Eli Lilly)

17.00 End of first day

Day 2

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

10.15 Intro to CTD & module 3
Bart De Spiegeleer (UGent)

11.15 coffee break

11.30 CTD module 4
Karen De Smet (FAMHP)

12.30 lunch

13.15 CTD module 5
Nele Steens (FAMHP)

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

15.30 coffee break

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

17.15 Closing remarks
Marc Benijts (BRAS)

17.30 End of course

The language for the 2 days is English except for the last session of Day 2 that will be given in Dutch.


Fees: 900€ for a BRAS member - 1.100€ for a non BRAS Member

Cancellation: In case of cancellation after 12 May 2014, the fees are due and will be invoiced.

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