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MDR Symposium

14/12/2021

During this meeting, representatives of the FAMHP and representatives of the BAREC working group on MDR will attempt to provide uniform answers to the questions that were raised by the ethics committees.

For more information, please contact info@barec.be

14/12/2021

MDR Symposium

During this meeting, representatives of the FAMHP and representatives of the BAREC working group on MDR will attempt to provide uniform answers to the questions that were raised by the ethics committees.

For more information, please contact info@barec.be

20/05/2021

BAREC Generel Assembly

(members only)

During this assembly, a new board was elected.

(see board page).

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

EMA CTIS training

Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trals Information System 5CTIS ahead of its planned launch.

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Clinical Trial College: call for candidates members

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 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

 

09/02/2021

Online information session
CTR review – submission procedure FAGG (members only).

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

 

EMA information & training events

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.

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

Evaluation of Biobanks

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

EC and Biobank

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