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Session 1: Transition Periods for Clinical Trials from Directive (2001/20/EC) to Regulation (536/2014)
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure
AbbVie, United States
Ana Zanoletty Perez
Head of Clinical Trials Transformation Workstream
European Medicines Agency, Netherlands
Session 1: Transition Periods for Clinical Trials from Directive (2001/20/EC) to Regulation (536/2014)
Speaker(s)
Transitioned Clinical Trials - Current Status and Key Metrics
Noemie Manent, PharmD
European Medicines Agency, Netherlands
TDA-CTT Operations Workstream Lead
Current Status about transitioning Clinical Trials and next steps
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Follow up on Transitioned Clinical Trials from Sponsors' Perspective
Scott Feiner
AbbVie, United States
Senior Manager, Trial Disclosure
Follow up on Transitioned Clinical Trials from CROs' perspective
Fatima Pimentel
Syneos Health, Spain
Director, Regulatory Consulting
Follow up on Transitioned Clinical Trials from Regulatory Perspective
Susanne Lerch
Paul-Ehrlich-Institut, Germany
Scientific Officer
Follow up on Transitioned Clinical Trials from Ethics Committee Perspective
Friederike Heckmann Heckmann
Medical Association Westfalen- Lippe, Germany
Ethics Commission
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