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European guidance on the management of clinical trials during the COVID-19 pandemic

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 prevention of COVID-19,
  • ongoing clinical trials in Belgium, and
  • the advice for new non-COVID-19-related clinical trials.

This guidance is supported by the FAMHP, BAREC and the CT-College.

Please note that on some subjects, a more detailed national guidance is being prepared on the conditions for direct distribution of the medicinal product to the patient.

This national guidance is expected to be published by the 25th of March 2020 and will be attuned to the European guidance.

30/11/2019

BAREC Meeting 30/11/2019  The next BAREC meeting will take place on Saturday 30 November 2019 AM. The meeting will mainly be dedicated to the presentation of the work of the BAREC workgroups (see section “workgroups” on this website).

Accreditation for economics and ethics has been applied for. 

09:00 Welcome // News from the association.   Christel Vansteenkiste, UZ Brussel, board member, Prof. dr. Jean-Marie Maloteaux, UCL, board member, Dr S. Graux, board member 
09:20 BAREC WG Biobanks. Proposal for a common checklist for the evaluation of biobanks by the ethics committees.  Dr. Pieter Moons, UZA 
10:00 BAREC WG Remaining part of the law on experiments dd 7/5/2004. Issues with regard to the revision of the law.  Angélique Rézer, UZ Leuven  
10:40 ***Break***
11:10 BAREC WG Harmonisation of the Ethics Committee’s daily practices. Workflow for multicentric trials.    Evelien Claes, UZ Leuven 
11:50 BAREC WG Medical devices. Implementation of de MDR in the Belgian legislation. Audrey Van Scharen, UZ Brussel 
12:30 Conclusion

LOCATION:  UCL WoluwéAuditoire central Maisinhttps://uclouvain.be/fr/facultes/mede/auditoires.html

REGISTRATION: The meeting is free for the members but registration is requested through following link: https://forms.gle/7wXNpfzGJxN9phVG8 

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

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16/05/2019

Barec General Assembly

Members only.

Date: May 16th, 2019

 

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