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Virtual

Oct 17, 2023 1:30 PM - Oct 17, 2023 5:30 PM

(Central Europe Standard Time)

EMA Clinical Trial Information System (CTIS) Information Day

The virtual event aims to support sponsors of clinical trials in preparing and proceeding with the transition of their clinical trials to meet the deadline of 30 January 2025. Commercial and non-commercial sponsors with experience in transitioning trials as well as representatives from EMA and EU/EEA member states will share insights and best practices.

Back to Agenda

Part I - Presentations

Session Chair(s)

Marianne Lunzer, DrMed

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

AGES, Austria

Noemie Manent, PharmD

TDA-CTT Operations Workstream Lead

European Medicines Agency, Netherlands

Speaker(s)

Transition Period For Clinical Trials from Directive(2001/20/EC) to Regulation (536/2014) - Regulatory Considerations

Linda Abdelall

European Commission, Belgium

Policy Officer, DG SANTE

Transition Period For Clinical Trials from Directive(2001/20/EC) to Regulation(536/2014) – Considerations From Sponsor Perspective

Caroline Correas, MA

Switzerland

Associate Director, Global Regulatory Policy

Ethics Committee Experience and Insights Related to Transitioning Clinical Trials

Maria Elena García Méndez

Universitary Hospital La Paz, Spain

Pharmacist, member of the Technical Secretariat of the Ethics Committee

Member States Experience And Insights Related To Transitioning Clinical Trials

Laura Lavin de Juan

Spanish Agency of Medicines and Medical Devices (AEMPS), Spain

Head of Service in the Clinical Trials Division

Member States Best Practice Guidance For Sponsors to Transition Clinical Trials

Monique Al, PhD

Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Special advisor CCMO

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