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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 Change Management Lead, European Medicines Agency, Netherlands
Speaker(s)
Linda Abdelall
Policy Officer, DG SANTE, European Commission, Belgium
Transition Period For Clinical Trials from Directive(2001/20/EC) to Regulation (536/2014) - Regulatory Considerations
Caroline Correas, MA
Associate Director, Global Regulatory Policy , Switzerland
Transition Period For Clinical Trials from Directive(2001/20/EC) to Regulation(536/2014) – Considerations From Sponsor Perspective
Maria Elena García Méndez
Pharmacist, member of the Technical Secretariat of the Ethics Committee, Universitary Hospital La Paz, Spain
Ethics Committee 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 Experience And Insights Related To Transitioning Clinical Trials
Monique Al, PHD
Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Member States Best Practice Guidance For Sponsors to Transition Clinical Trials
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