To tackle key GDPR challenges, we are launching a new ad hoc working group. We are calling for members to join. Legal professionals are especially encouraged to participate and share their expertise.
The working group will focus on key action points, including:
· Developing advice on the legal grounds for processing personal data.
· Revising the confidentiality sections of the Informed Consent Form (ICF).
The working group will come to an end once the above action points are completed.
In December we were informed by the FAMHP, that the outstanding payments for 2018 would be paid within 4 months. The Royal Decree has been published on 19 December 2024, see below.
Het Koninklijk Besluit betreffende de toekenning van de subsidie 2018 aan ethische comités werd op 19/12/2024 gepubliceerd in het Belgisch Staatsblad. U kan de publicatie raadplegen via volgende link: https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. De tabel vermeldt het bedrag waarop uw Ethisch comité recht heeft.
L’Arrêté Royal relatif à relatif à l’octroi du subside 2018 aux comités d’éthique a été publié au Moniteur belge en date du 19/12/2024. Vous pouvez consulter la publication via le lien suivant : https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. Le tableau reprend le montant auquel votre comité d’éthique a droit.
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.
Day 1: 22 Feb 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 | European Medicines Agency (europa.eu)
Day 2: 4 Mar 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 | European Medicines Agency (europa.eu)
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.
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