Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal

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

This bitesize talk provides an opportunity for sponsors to familiarize themselves with the revised transparency rules that will become applicable on 18 June 2024. Furthermore, sponsors will also be able to familiarize themselves with the new CTIS Public portal, that will be live as of 18 June. 

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.

To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials:

• Clinical Trials Information System: training and support
• Clinical Trials Information System (CTIS): online training modules
• Quick guide for the users

Please note that the training material is currently being updated and will be made available shortly before the event.

Live participation via Slido

We encourage event participants to submit questions related to sponsor preparedness in advance of the webinar (use code: #bt20jun). The most popular questions submitted in advance of the event will be answered by speakers during the panel session. Please provide your questions by 13 June 2024, noon.