Here you will find an advice from the College and the FAMHP to the sponsors and sites of clinical studies on the need for an updated ICH-GCP certificate for new submissions after the...
This advice was jointly prepared by BAREC and the College Board, and approved for publication on 20/06/2025. You will find instructions on the signing of the informed consent form by the parents...
This Q&A on the follow-up of a participant’s pregnancy or the partner of a participant for an interventional clinical trial was developed by BAREC and approved by the College Board on 20/06/...
This note developed by pharma.be aims to provide guidelines for creating electronic information or digital campaigns about specific authorized clinical trials and disseminating them via social...
This annual report provides an overview of the activities carried out by the College during the period from January to December 2023, relating to dossiers governed by the CTR/MDR/IVDR regulations...
This new template for the Informed Consent Form (ICF) for clinical investigations for adult patients involving a medical device was prepared by a BAREC working group consisting of representatives...
This new template for the Informed Consent Form (ICF) for interventional clinical trials with IMP on adult healthy volunteers was prepared by Healixia and BAREC and is based on the already...
Following several discussions between the College, the AFMHP, and some industrial and academic sponsors, this recommendations to ethics committees concerning the approval of pre-recruitment...
Following several discussions between the College, the AFMHP, Healixia Early Development and the vaccine centrum (CEVAC and Vaccinopolis), this recommendations concerning the use of force majeure...
Following several discussions between the College, the FAMHP, and some industrial and academic sponsors, this recommendation to ethics committees concerning the reduction of the number of RFIs...
