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.
During this BRAS afternoon session a status update will be provided around the new clinical trial regulation. We will look at it on the EU level with an update on the EU portal and submission process of a clinical trial application. Also the Belgian context will be discussed and how the Agency is organised to prepare for the Clinical trial regulation. The new law on clinical trials was published on May 22nd 2017 in ‘The Belgian Official Journal’. At time of the session the Agency will be able to provide a status update around the pilots and it is also the intention to share the Sponsor’s experience with these pilots.
- How did the agency prepare for the CTR
- EU Clinical trials
- Short status update of EU portal
- Submission of a dossier: the process + the content (safety part – process of selection of EC – suitability of the site)
- Belgian context
- New law: published on 22/05/2017
- Royal decrees following the new law
- Role of the college that makes the selection on EC and that assesses the quality of the EC EU context (Mevr. Lisa Marynen)
- Status update Pilots + first results: experience by the agency
- Pilots with sponsors: experience by one of the sponsors
Speakers names will follow very soon.
Program and speakers
If you need more assistance, please contact Brigitte Frenay at email@example.com 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.
14 December 13:30 » 14 December 17:30
De Montil - Moortelstraat 8 - 1790 Affligem