If the clinical investigation with a CE-marked medical device, that is used within its intended purpose, is not considered to be a PMCF, only positive advice from the relevant EC(s) is necessary and “Regulatory pathway: EC only” needs to be followed. The “Other clinical investigations” are regulated under the Royal Decree of 18 May 2021 and as such a timeline of 45 days is applicable to issue an EC-decision.
EC forms for evaluation of biobanks (last versions) developed by the BAREC workgroup on biobanks, in consultation with different stakeholders.
BAREC symposium
17 november 2022
Brussels (Royal Library of Belgium)
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Date: 17/11/2022
Time: 08h00
Location: Brussels (Royal Library of Belgium)
organized by the Ethics Committee az groeninge. More info:
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Dear Sir, Madam,
On the 17th of May 2022, the Commissie Medische Ethiek az groeninge is organizing the symposium “Prenatal genetic screening anno 2022: Medical advances and Ethical challenges”. We would be delighted with your attendance at our symposium and would be very grateful if you could distribute our invitation to the members of your Ethics committee
More information about the program & speakers, and registration can be accessed via the following link: https://events.azgroeninge.be/Prenatalegenetischescreening2022/nl/home
(Use the top buttons to navigate across the different information)
Participation is free, but registration is necessary.
We are looking forward to your attendance and a successful discussion.
Yours sincerely,
Dr. Peter Doubel
Date: 17/05/2022
Time: 19h00
Location: Auditorium het Notenhof az groeninge Kortrijk / Online
Language: The presentations will be in Dutch.
Accreditation: “Ethiek & Economie” has been requested
BAREC General assembly
(members only)
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22/3/2022, 19:30
(online) symposium on the legal and ethical challenges concerning decentralized trials.
For more info contact info@barec.be
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Please contact us for more information on becoming a member via: info@barec.be
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
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
(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.