CTIS was launched on 31 January 2022, starting the clock for the one-year transition time for all sponsors of clinical trials. During the first year of the transition period, clinical trial sponsors can choose whether to submit an initial clinical trial application in...

BAREC Board Elections 2021 According to the BAREC statutory articles, election of a new board will be held during the general assembly of 20/5/2021. More information.

Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trals Information System 5CTIS ahead of its planned launch. The training materials aim to help users comply with their obligations under the Clinical Trial Regulation (No...

The Clinical Trials College is looking for: four physicians experienced in the execution or evaluation of clinical trials, two lawyers, two experts in quality control systems. The call for candidates was published in the Belgian Official Gazette on 11/02/2021. For...

The European Medicines Agency is organizing an online two-part information and training session about Clinical Trial Information Systems (CTIS). This webinar is meant for micro, small and medium enterprises (SMEs) as well as for non-commercial sponsors (academia). ...

The CT-college recently published a template for informed consent form (ICF), that can be used for interventional clinical trials with an investigational vaccine in adult healthy volunteers. Read more. If you would like to read more about this, please consider...

The CT-college recently published the following guidance on its website. This document describes the restrictions that should be taken into account when using electronic methods to inform a potential participant of a clinical trial and/or to have the ICF signed. Link:...

Evaluation of Biobanks In addition to the initial submission form, the BAREC WG for biobanks has developed and finalized a document that aims to support the ethics committees performing the biannual evaluation of biobanks.   EC Submission form for Biobanks EC Form for...

On its latest general assembly, BAREC agrees on a statement concerning the section "trial at a glance" of the model ICF for interventional clinical trials with IMP adults. Read more. If you would like to read more about this, please consider becoming a Barec-member...

A call for membership of the college for clinical trials has recently been published by the CT college.   Would you like to become a member of the Board of the Clinical Trials College? The Clinical Trials College is looking for physicians, lawyers, and experts in...

Today an updated version of the European guidance was published on EudraLex10: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf The related press release announcing the publication can be found here:...

Please find an updated version of the European guidance was published on EudraLex-10. Go to document The aim is to provide sponsors and investigators with guidance on how to mitigate the effects of the pandemic in order to protect the safety, well-being and integrity...

A national guidance has been published on the website van the FAMHP:https://www.fagg.be/nl/news/coronavirus_belgische_richtsnoer_voor_het_beheer_van_klinische_proeven_tijdens_deThis national  guidance is to be read together with the latest version of the European...

A European guidance (https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf) has been published, which will provide directions to sponsors and investigators on the subject of clinical trials for treatment or...

Workshops about the impact of GDPR on scientific research. Participation free, but registration mandatory. More information on: https://www.ewi-vlaanderen.be/evenementen/gdpr-en-het-onderzoeksbeleid             If you would like to read...

Moniteur Belge - Belgisch Staatsblad N.39 22 May 2017- Wetsontwerp/Projet de Loi  Wet betreffende klinische proeven met geneesmiddelen voor menselijk gebruik. Loi relative aux essais cliniques de médicaments à usage humain.     If you would like to read more...

"Impact of the new regulation on clinical investigation in Belgium." A presentation by Steve Eglem, FAMHP.Available on demand: info@barec.be If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area....