Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach

This is a CTIS bitesize talk which focuses on the approaching end of the transition period for clinical trials under the EU Clinical Trials Regulation (EU No 536/2014). It provides guidance on transitioning trials and submitting various notifications, such as unexpected event reports, urgent safety measures, and serious breaches.

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Union (EU) and the European Economic Area (EEA).

During this session, CTIS experts will also take this chance to provide sponsors with additional guidance on how and when to submit notifications unrelated to the trial or recruitment period, such as unexpected event notifications, urgent safety measures and serious breaches. Sponsors will have the opportunity to ask questions on these CTIS topics during the event. 

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. 

It will be a live broadcast; no registration is required for those wishing to follow the live broadcast on EMA’s website.

EMA cannot provide attendees certificates of attendance for this event. 

To make the best out of this session, attendees are highly recommended to first consult the available online training and support materials:

• CTIS training and support materials
• Clinical Trial Information System (CTIS) - Sponsor handbook 
• Clinical Trials Information System (CTIS): online training modules: Module 23 - Transitional trials and Module 05 - Manage a clinical trial through CTIS

A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days. Please subscribe to the clinical trials newsletter for updates on the availability of CTIS event video recordings. 

We encourage event participants to use Slido and to submit questions related to sponsor preparedness in advance of the webinar (use code:# bt16oct). The most popular questions submitted in advance of the event will be answered by speakers during the panel session. 

Please provide your questions by 9 October 2024, 12:00.