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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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Webinar: Doing More with Data: Data Anonymization and Pseudonymisation under the GDPR on April 17, 2019

Webinar: Doing More with Data: Data Anonymization and Pseudonymisation under the GDPR on April 17, 2019 Date & Time: 17 April 2019 from 3:30 PM to 5:00 PM (CET)    Attendance Fee: € 90,- for EUCROF non-members € 60,- for EUCROF members using the code DATA0417 Register here    

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Surfing the innovation wave, an interview with the Director General EFPIA

Surfing the innovation wave, an interview with the Director General EFPIA   Influential industry body, EFPIA, has for years helped pharma improve transparency and repair its long-tainted reputation. Tackling key issues such as innovation, patient access and collaborative R&D, Eyeforpharma caught up with the new Director General, Nathalie Moll, to discover where their focus is for […]

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Direct to Patient (D2P) shipment for Clinical Trials – Survey

Direct to Patient (D2P) shipment for Clinical Trials – Survey Dear Sponsor, CRO, Investigator or Patient, Within Europe and more specifically within Belgium, Direct To Patient (D2P) shipments have limitations within the current regulatory framework. Considering the growing enthusiasm of pharma companies, investigators and patients performing D2P shipments in the US, we need to investigate […]

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