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Spotlight

“GDPR in practice”, an Interactive Workshop dedicated to the practical aspects of GDPR rules in the frame of Clinical Trials.

Friday, November 29, 2019 from 12:30 PM to 5:00 PM (CET) Faculty Club 14 Groot Begijnhof 3000 Leuven

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Our latest news

Clinical trials guidelines

On the 15th October 2019, the European Commission (EC) published a set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable. Please see under the following link EudraLex – Volume 10 – Clinical trials guidelines : https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1

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PUBLICATION of ICF templates for interventional trials on adult patients

A dedicated working group has prepared a new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients. The working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was […]

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