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 Trials Information System - Sponsor user training programme

Virtual

Oct 28, 2024 – Oct 31, 2024

Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs, submitting a substantional modification, search and download options. Participants receive access to the CTIS training environment and will practice basic functionalities during the live training course.

	List price:
Virtual Event Price	€1,640.00

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EMA Clinical Trial Information System (CTIS) Information Day

Agenda

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