Regulatory Affairs Community

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, A blog "Four reasons you should consider becoming a lay member of the Confidentiality Advisory Group (CAG)" published by Dan Roulstone, lay ...

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

Hello All - Hold the date for the next AdPromo WG being held on May 8 @ 12 - 1 PM ET via Zoom . Please note that this is the 2nd Wednesday of the month. ...

Will the presentation recording and/or slides be posted? ------------------------------ Natalia Kosteckyj Emergent Biosolutions Winnipeg MB -------- ...

Here are the slides and the link to the recording in the DIA Reg. Affairs Community for our RIM IA meeting on April 17th. Thanks again to Bala for ...

Hi all, On Apr 25, 2024, EMA published the revised " Guide on access to unpublished documents ". This version includes the following updates: Removal ...

Hi all, HRA rolled out a draft model Investigator Initiated Study Agreement on which commenting is open until June 03, 2024 via email. Please see below ...

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 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), ...