The Clinical Trial College (CT College) ensures that the ethical assessment of clinical trials on medicinal products for human use is carried out in Belgium :
The safety of the participants in the clinical trials is essential in this regard.
As described in the law of 7 May 2017, the mission of the CT-College is as follows:
 Federal Agency for Medicines and Health Products
The CT College is an independent body set up within the FPS for Public Health, Food Chain Safety and Environment (FPS HFCSE).
How are we organized?
Lisa Marynen (NL)
Katelijne Anciaux (NL)
Sébastien Vanhiesbecq (FR)
Board (to be appointed)
Expert in Quality control systems
Doctor with experience in clinical tests
Links to Belgian legislation:
Links to European legislation:
On the website of the European Commission
PDF version in English
To prepare the implementation of the CTR in Belgium, a number of clinical trial applications have been submitted by sponsors to the FAMHP as pilot projects since May 2017. The procedure to approve clinical trials complies with the national legislation of 7 May 2004, but the application dossier as well as the assessment follow the spirit of the new European Regulation and the Belgian law of 7 May 2017.
The administrative staff of the CT-College works during our pilot projects according to the tasks and competences described. You will find more information about this pilot project on the FAMHP’s website.
Along with the administrative staff of the CT-College and with the FAMHP, a few members of fully recognized ethics committees contribute to the procedures for implementing the CTR in Belgium.
Along with the administrative staff of the CT-College and with BAREC, a few members of fully recognized ethics committees, representatives of patient organisations and Pharma.be
contribute to the revision of templates for the Informed Consent Form.
 Clinical Trial Regulation
 Belgian Association of Research Ethics Committees
This presentation gives more information:
Implementation of CTR in Belgium and the impact on the ethical review process
General mailbox: firstname.lastname@example.org
This document contains FAQs on the Informed consent procedure in trials ongoing at or completed before 25th May 2018.
This presentation gives you more information on how the CTR has an impact on :
Press release of 21 April 2017 on the publication of the law on clinical trials with medicinal products for human use.
Information session for fully recognized ethics committees wishing to take part in the pilot project: