Session on clinical trials - NEW DATE

This year’s BRAS seminar on clinical trials will be complementary to the earlier FAMHP symposium of 26/09/2017. Together with the FAMHP we will zoom in on the regulatory implications of the new legislation (EU portal, submission process, Belgian efforts). December will also be the perfect timing to provide all stakeholders with a status update on the pilots.

The date of this session was changed to allow our members to participate in the FAMHP symposium on 26 September if desired.
Symposium organised by the FAMHP with focus on the strategic aspects of the new legislation on clinical trials published on 22/05/2017.

Session on Clinical Trials – 14.12.2017 – Afternoon

The speakers are from the FAHMP (Federal Agency for Health and Medicinal Products) and one testimonial from a company having worked on the testing

Presentations and slides in English

Programme and spreakers:

Introduction Belgium in/and Europe

13h30-13h45 Organisation at the Federal Agency for Medicines and Health Products - FAMHP
13h45-14h00 CTR EU and Nationally: How did the agency prepare for the CTR
14h00-14h40 New law: published on 22/05/2017
                      Royal decrees following the new law
                      Greet Musch, FAMHP

EU Clinical trials

14h40-15h00 Short status update of EU portal
                      Pieter Vankeerberghen, FAMHP

15h00-15h15 Submission of a dossier: process + content (Part I, Part II: – suitability of the site)
                      Anne Lenaers, FAMHP

15h15-15h45 Coffee break

15h45-16h05 Role of the college that makes the selection on EC and that assesses the quality of the EC EU context
                      Katelijne Anciaux, Federal Public service of Health, food chain safety and environment

16h05-16h15 Status update Pilots + first results: experience by the agency and College
                      Anne Lenaers, Pieter Vankeerberghen, FAMHP & Katelijne Anciaux, Federal Public service of Health, food chain safety and environment

16h25-16h45 Pilots with sponsors: experience by one of the sponsors
                      Brigitte De Witte, Sanofi

16h45-17h00 Q&A

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 Brigitte at bras@bras-org.be or call her on 02.757 06 29.

Fees: BRAS member 150€ - Non-BRAS member 350€

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 6 December 2017 or no-show, the fees are due and will be invoiced.

 

Program and speakers

Download program

If you need more assistance, please contact Brigitte Frenay at bras@bras-org.be or call her on +32 2 757 06 29.

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 06/12/2017 or no-show, the fees are due and will be invoiced.

Event info

14 December 13:30 » 14 December 17:00

Location
De Montil - Moortelstraat 8 - 1790 Affligem

Language
English

Member price
€ 150.00

Non-member price
€ 350.00