(members only)
During this assembly, a new board was elected.
(see board page).
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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.
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Online information session
CTR review – submission procedure FAGG (members only).
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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
MDR (fees) : Online information session (members only).
The BAREC workgroup on biobanks gave some more insights in the biannual evaluation of the biobanks during an online information session organised by BAREC and BBMRI.be
BAREC en BBMRI.be voorstellen tweejaarlijks rapport
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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.
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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.
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