EMA webinar – Redesigned CTIS training material for sponsor users
08/07/2025 Regulatory newsThe EMA will publish a revised Sponsor Handbook for the Clinical Trials Information System (CTIS) on the EMA website on 9 July 2025. This updated handbook replaces all previous sponsor training modules and will serve as the definitive reference for sponsor users of CTIS.
It has been redesigned based on stakeholder feedback to improve the usability and navigation of the information. The guide has been reviewed and validated by a stakeholder focus group under the ACT EU multi-stakeholder platform.
We encourage all clinical trial sponsors to consult the new handbook as their primary guidance resource and share this update widely within your networks.
EMA webinar – 9 July 2025
To help sponsors use this new format, the EMA is hosting a dedicated CTIS Bite-Size Talk on Wednesday, 9 July 2025, 15:30 CEST (14:30 Irish time).
The webinar will include an introduction to the new handbook’s structure, key features, and a live Q&A.
You can attend the live webinar by visiting the EMA webinar page. You do not need to register in advance.