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...
Please note that a new version of the template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational vaccine in adult healthy volunteers is being prepared...
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 dieser Stellungnahme von BAREC, die vom Board genehmigt wurde, finden Sie weitere Informationen zu den „Patient Facing Documents“ und wie sie zur Bewertung durch die EKs eingereicht werden. ...
This annual report provides an overview of the activities carried out by the College during the period from May 2021 to December 2022, relating to the dossiers governed by the CTR/MDR/IVDR...
Um sicherzustellen, dass die ethische Bewertung sowohl klinischer Studien mit Arzneimitteln für den menschlichen Gebrauch als auch klinischer Studien mit Medizinprodukten in Belgien auf...
