We are delighted to invite you to our general assembly on the 22nd of May 2024.
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 line with the Clinical Trials Directive 2001/20/EG or under the Clinical Trials Regulation (CTR), via CTIS.
According to the BAREC statutory articles, election of a new board will be held during the general assembly of 20/5/2021.
The Clinical Trials College is looking for:
The call for candidates was published in the Belgian Official Gazette on 11/02/2021.
For more information we refer to:
https://www.health.belgium.be/fr/news/medecin-juriste-expert-qualite-appel-candidature
Deadline for application by registered letter: 25/02/2021.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
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).
CTIS for SME and non-commercial sponsors: two-part information/training event foreseen Q1 2021.
EU Portal.
For Micro, Small to Medium Enterprises (SMEs) and academia, EMA is organizing a targeted webinar to provide training on CTIS and its functionalities. The webinar is divided into two parts (Day 1 and Day 2) and participants are advised to attend both. This two-part event is free of charge.
As per current planning, Day 1 on 22ndFebruary 2021 will present CTIS access management, user management and different roles in CTIS. Day 2 on 4thMarch 2021 will focus on CTIS functionalities -how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.
The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.
For more information on this SME/academia event, please contact CT.Sponsortraining@ema.europa.eu.
For more information on EMA engagement with academia, please see https://www.ema.europa.eu/en/partners-networks/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.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
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.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
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 Biannual Evaluation of Biobanks
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
