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.

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Session 2 - Transparency in clinical trials

Session Chair(s)

Marianne Lunzer, DrMed

Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria

Francesca Scotti

CTIS Transparency Lead, European Medicines Agency, Netherlands

Transparency in Clinical Trials

Speaker(s)

Overview of new transparency rules

Francesca Scotti

CTIS Transparency Lead, European Medicines Agency, Netherlands

Lora Killian, MBA

Clinical Trial Transparency and Disclosure Lead, Pfizer, United States

New Transparency rules –How to manage from a non-commercial Sponsors’ Perspective

Andrea Seidel-Glaetzer, MA, RN

Head of Project Management , Coordination Centre For Clinical Trials Heidelberg (KKS), Germany

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EMA Clinical Trial Information System (CTIS) Information Day

Session 2 - Transparency in clinical trials

Session Chair(s)

Marianne Lunzer, DrMed

Francesca Scotti

Speaker(s)

Be informed and stay engaged.