Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
Since 2017, 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 have developed a guidance document to assist sponsors in this process. In this guidance document you will find, among others, the timelines for the procedures in the pilot project and the list of documents to be submitted.
This guidance document is adapted as the pilot project progresses. Version 8.0 of the guidance document for clinical trials sponsors replaces the previous versions and is directly applicable.
If you want to participate in this pilot project, please fill in the form and send it to CTRpilot@fagg-afmps.be before submitting your dossier. Once you have done this, you can submit the dossier using the CESP platform. Make sure your dossier is complete before submitting it.
Call for action the participate in pilot projects