Update on the new Clinical Trial Regulation pilot project

As previously reported, the FAMHP has started a pilot project for clinical trials in Belgium in collaboration with the new college charged with the designation of the ethics committee for the evaluation of clinical trials, the current ethics committees and the 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 among others the timelines for the procedures in the pilot project and the list of documents to be submitted.

 

This guidance document will be adapted as the pilot project progresses.

 

Today the FAMHP publishes version 4.0 of this document which replaces the previous versions and is directly applicable.

 

If you wish to participate in this pilot project, please fill in the form and send it to CTRpilot@fagg-afmps.be.

 

More information

Guidance CTR Pilot project

Last updated on
15/05/2018