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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On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April.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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EMA/CHMP statement on Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments

Dear Industry Stakeholders, The EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of CIVID-19. The statement promotes a harmonised approach to data collection […]

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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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