FAMHP organises two information sessions to provide all sponsors and applicants for clinical trials with as much information as possible about the new Regulation. BeCRO is actively involved in the organisation of these workshops. The first information session took place on 23 September 2021.During this session, an update was given on the different aspects of the […]

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary […]

The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic (V4 04Feb21) expands the use and scope of remote source data verification (rSDV) in clinical trials. Now, in addition to trials involving the treatment or prevention of COVID-19, remote SDV may be considered for […]

From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. The current COVID-19 pandemic has a significant impact on the FAMHP’s available capacity to process clinical trial dossiers. We are therefore forced to temporarily limit the number of initial […]

BeCRO members can participate in EUCROF Webinars and Trainings at reduced cost. Please visit the link below to find the latest information. The code for the fee reduction can be requested via admin@becro.be https://www.eucrof.eu/webinars

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

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 […]

On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April.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

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 […]