GUIDANCE FOR SPONSORS ON THE USE OF ELECTRONIC INFORMED CONSENT IN INTERVENTIONAL CLINICAL TRIALS IN BELGIUM

On 30 September 2020, the Working group Informed Consent published version 1.0 of the guidance document on the use of e-consent in Belgium. Please find hereby the link to the document: https://overlegorganen.gezondheid.belgie.be/sites/default/files/content/guidance_on_use_of_e-icf_vf.pdf

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On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Please note that this document is to be read in conjunction with the latest version of the European guidance and that the national guidance provides some more detailed clarifications and additional topics of interest. This text was written by the FAMHP, the Clinical Trial College and the Belgian association of Research Ethics Committees (BAREC).The information […]

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Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April. https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf

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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

On 28th of April, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published version 3 of their guidance to sponsors on how to manage clinical trials during the COVID-19 (Coronavirus) pandemic. Key changes from v2 (27-03-2020): distributor to trial participant IMP shipment, monitoring, remote source data verification […]

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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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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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BeCRO invited in Tokyo to promote Belgium as a gateway to clinical research in Europe

BeCRO invited in Tokyo to promote Belgium as a gateway to clinical research in Europe Bruxelles Invest & Export invited BeCRo to present the attractivness of Brussels for clinical trials in the European Union, during the Brussels Days in Tokyo on May 18, 2016. This event was organized on the occasion of celebrating 150 years […]

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