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

Scientific Specialist

European Medicines Agency, Netherlands

Transparency in Clinical Trials

Speaker(s)

Overview of new transparency rules

Francesca Scotti

European Medicines Agency, Netherlands

Scientific Specialist

Demonstration of the new Public Portal

Charalampos Drosos

European Medicines Agency, Netherlands

CTIS Change Management Officer, Data Analytics and Methods Task Force

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

Polyana Bastos

Actelion Pharmaceuticals, Switzerland

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

Andrea Seidel-Glaetzer, MA, RN

Coordination Centre For Clinical Trials Heidelberg (KKS), Germany

Head of Project Management

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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)

Overview of new transparency rules

Demonstration of the new Public Portal

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

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

Be informed and stay engaged.