Clinical Trials Information System (CTIS) Bitesize talk: Redesign of the CTIS training material for sponsor users

• Date:
  Wednesday, 09 July 2025, 15:30 - 17:00 Amsterdam time (CEST)
• Location:
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

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). 

This CTIS Bitesize Talk presents an opportunity to become acquainted with the revised Sponsor Handbook, which will serve as the definitive reference for sponsor users operating within CTIS. Effective 9 July, it will supersede the existing sponsor training modules.

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 have a quick look at the current:

• CTIS training and support materials
• Clinical Trial Information System (CTIS) - Sponsor handbook
• Online modular training programme

Video recording

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Documents

Presentation - Redesign of the CTIS training material for sponsor users - CTIS Bitesize talk 9 July 2025