EMA Clinical Trial Information System (CTIS) Information Day

Focus of this event will be on the follow up steps transitioned clinical trials and the revised transparency rules. From 31 January 2025 onwards, in only a few months time, the transition period is over and sponsors will need to comply with their obligations under the CTR and its Delegated Acts for all clinical trials conducted in the EU/EEA. On 18 June 2024, the revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable, with the launch of a new version of the CTIS public portal.

Agenda

Day 1 Oct 17, 2024

1:30 PM — 1:40 PM

Welcome Note

1:40 PM — 3:30 PM

Session 1: Transition Periods for Clinical Trials from Directive (2001/20/EC) to Regulation (536/2014)

3:05 PM — 3:30 PM

Q&A and Panel Discussion

3:30 PM — 4:00 PM

Break

4:00 PM — 5:10 PM

Session 2 - Transparency in clinical trials

5:10 PM — 5:30 PM

Q&A and Wrap-up

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EMA Clinical Trial Information System (CTIS) Information Day

Agenda

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