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.

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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

Policy Officer, DG SANTE

European Commission, Belgium

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

Associate Director, Global Regulatory Policy

Bristol Myers Squibb , Switzerland

Ethics Committee Experience and Insights Related to Transitioning Clinical Trials: Maria Elena García Méndez

Pharmacist, member of the Technical Secretariat of the Ethics Committee

Universitary Hospital La Paz, Spain

Member States Experience And Insights Related To Transitioning Clinical Trials : Laura Lavin de Juan

Head of Service in the Clinical Trials Division

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

Member States Best Practice Guidance For Sponsors to Transition Clinical Trials: Monique Al, PhD

Special advisor CCMO

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

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