This annual report provides an overview of the activities carried out by the College during the period from January to December 2024, relating to dossiers governed by the CTR/MDR/IVDR regulations...
This advice was prepared by BAREC and approved by the College Board on 10/10/2025. The advice provides an overview of the retention periods applicable to study documents within research projects,...
This advice was prepared by BAREC and approved by the College Board on 10/10/2025. The purpose of this advice is to raise awareness among study sites about the importance of ensuring that their...
This statement was prepared by BAREC and approved by the College Board on 10/10/2025. The statement clarifies the collection of ethnic information from the target population of clinical studies....
This document addresses the anonymization of samples and the lifting of traceability of human bodily material. It was prepared by BAREC, revised by experts from the College Board, and approved on...
Here you will find an advice from the College and FAMHP to sponsors and sites of clinical studies on the need for an updated ICH-GCP certificate for new submissions after the implementation of ICH...
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...
