BRAS Introduction to Regulatory Affairs 2019

!COMPLETED! - 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, organisational and administrative aspects of medical products given by experienced tutors from university, FAMHP and industry.

BRAS COURSE

 INTRODUCTION TO REGULATORY AFFAIRS

15th edition May 13-14, 2019

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 12 experienced tutors from university, FAMHP and industry.

Program and speakers

Day 1

08.30 Registration and coffee

09.00 Welcome & introduction to the course

            Marc Benijts (BRAS)

09.15 Pharmaceuticals – definitions – product life cycle

            Lieve Lammens (Janssen Research and Development)

10.15  The European Union and its institutions – The Belgian bodies

            Peter Bogaert (Covington & Burling LLP) – Charlotte Ryckman (Covington & Burling LLP)

11.15 coffee break

11.45  The pharmaceutical legislation (EU – B)

            Peter Bogaert (Covington & Burling LLP) – Charlotte Ryckman (Covington & Burling LLP)

12.45  Lunch

13.45 European Medicines Agency – EU procedures for Marketing Authorisations - part 1

            Ingrid Theeuwes (PhaRa consulting)

14.45 coffee break

15.00 European Medicines Agency – EU procedures for Marketing Authorisations - part 2

            Ingrid Theeuwes (PhaRa consulting)

15.45 Variations – renewals – extensions

            Lucie Favier (Merck Sharp & Dohme Europe)

17.00 End of first day

 

Day 2

 

09.00 Legislation for clinical trials

            Anne Lenaers (FAMHP)

10.15 coffee break

10.45 CTD module 3

            Evelien Wynendaele (Ugent)

11.45 CTD module 4

            Gaëlle De Meyer (FAMHP)

12.45 lunch

13.45 CTD module 5

            Nele Berthels (FAMHP)

14.45 Pharmacovigilance

            Michèle Sangeleer

16.00 coffee break

16.15 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

Registrations through our website. (www.bras-org.be)

For registration you click on the line of the session in “Future courses and events” on the Home Page and then sign up. If you are not yet registered on the website you will be asked to do so. The system will send you a confirmation of registration with payment modalities by return mail.

If you need more assistance please contact Isabel Tack at bras@bras-org.be or call her on 0472 97 35 74

Fees: BRAS member 900€ (excl. VAT) - Non-BRAS member 1.100€ (excl. VAT)

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 3 May 2019 or no-show, the fees are due and will be invoiced.

 

Program and speakers

Download program

If you need more assistance, please contact Isabel Tack at bras@bras-org.be or call her on +32 472 97 35 74.

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 03/05/2019 or no-show, the fees are due and will be invoiced.

Event info

13 May 09:00 » 14 May 17:30

Location
AFMPS / FAGG / FAMHP – Eurostation II – Place Victor Hortaplein 40, 1060 Brussels

Language
English

Member price
€ 900.00 excl. VAT

Non-member price
€ 1100.00 excl. VAT
Sign up