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...
In this advice given by the BAREC and approved by the Board, you’ll find more information about the Patient facing documents and their submissions for EC review. Version 2.0 was approved by the...
