As previously reported, the FAMHP has started a pilot for clinical trials in Belgium in collaboration with the new college charged with designation the ethics committee for the evaluation of clinical trials, the current ethics committees and sponsors of clinical trials.
FAMHP experts and the college developed a guidance document to assist sponsors in this process. In this guidance document you can find amongst other things the timelines for the procedures in the pilot and the list of the documents to be submitted.
This guidance document will be adapted as the pilot progresses.
Today we publish the version 3.0 of this document.
An empty submission dossier (containing the proposed templates) is also available on our website.
The FAMPH also invites sponsors of clinical trials to express their intent to be involved in the third wave of pilot projects that will start in January 2018.
To express your intent, please fill out this form and send it to CTRpilot@fagg-afmps.be