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 […]Read More "FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 15 December 2021 on the new Clinical Trial Regulation (CTR)."
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 […]Read More "Clinical Trials Information System (CTIS) reaches major milestone towards go-live and application of the Clinical Trial Regulation"
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 […]Read More "EU regulators expand use of remote source data verification in clinical trials during the COVID-19 pandemic"
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 […]Read More "Pilot project on Clinical Trial Regulation (CTR)"
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 firstname.lastname@example.org https://www.eucrof.eu/webinarsRead More "EUCROF Webinars and Trainings"
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.pdfRead More "GUIDANCE FOR SPONSORS ON THE USE OF ELECTRONIC INFORMED CONSENT IN INTERVENTIONAL CLINICAL TRIALS IN BELGIUM"
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 […]Read More "On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic"
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.pdfRead More "Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials"
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 […]Read More "Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic"
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 […]Read More "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"