EUCTR/CTIS Working Group

Hi all, EMA has published today (Apr 26, 2024) an updated version of Anonymisation of personal data and assessment of commercially confidential information ...

Hi all Nguyen et al.'s review article " Regulatory Issues of Platform Trials: Learnings from EU-PEARL " provides the most up-to-date assessment ...

Hi all EMA is offering a virtual training programme from 10 - 13 June 2024 at 09:00 (CEST) - 13:30 (CEST) , organised by DIA, to support sponsor user ...

Hi all This CTIS bitesize talk scheduled for 24 Apr 2024 aims to provide sponsors with information on alternate Investigational Medicinal Product Dossier ...

Hi all Sponsors transitioning their ongoing trials from EudraCT to CTIS may now consult the updated guidance documents from the European Commission ...

Hi all Sponsors transitioning their ongoing trials from EudraCT to CTIS may now consult the updated guidance documents from the European Commission ...

Hi all The latest improvements include enhancements in the authorisation and supervision of trials; collaboration between Member States on ad-hoc/safety ...

Hi all In Q2 2024, ACT EU is launching two pilots offering: a) harmonised scientific advice to support the submission of marketing authorisation and ...

Hi all, EMA published today the presentation and recording from the CTIS Bitesize Talk: How to submit a transitional trial in CTIS . This event was ...

Hi all, In addition to confirming the launch of revised rules for transparency in EU CTIS for June 18, 2024, EMA also published today (Apr 22, 2024), ...

Hi all Update from EMA on April 22nd via the ACT EU homepage and email communications, the revised CTIS (Clinical Trial Information System) transparency ...

Hi all, Please see below details for the Walk-in Clinic just announced by EMA, "Clinical Trials Information System (CTIS): Walk-in clinic - May 2024" ...

Hi all TransCelerate have published the slides and recording of their webinar, Enabling Individual Participant Data Return (iPDR): An Overview ...

Hi all The EMA has published an updated version of the Revised CTIS transparency rules, historical trials and interim period: Quick Guide for Users ...

Hi all, On Apr 12, 2024, EMA has published " HMA/EMA guidance document on the identification of personal data and commercially confidential information ...