The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for the three-year transition period from the Clinical Trials Directive to the Clinical Trials Regulation. Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS. In less than a year, from 31 January 2025 onwards sponsors will need to comply with their obligations under the CTR and its Delegated Acts.

The European Medicines Agency (EMA) is organising this open event to provide:

• reflection on the implementation of the Clinical Trials Regulation;
• reflection on transitional trials and how they are updated in CTIS;
• update on the current status of CTIS.

This EMA-hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.

No certificates of attendance will be issued for this event.

The event will be broadcast live. A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days.

Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.