Back to Agenda
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)
Noemie Manent, PHARMD
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
Transitioned Clinical Trials - Current Status and Key Metrics
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
Current Status about transitioning Clinical Trials and next steps
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States
Follow up on Transitioned Clinical Trials from Sponsors' Perspective
Fatima Pimentel
Director, Regulatory Consulting, Syneos Health, Spain
Follow up on Transitioned Clinical Trials from CROs' perspective
Susanne Lerch
Scientific Officer, Paul-Ehrlich-Institut, Germany
Follow up on Transitioned Clinical Trials from Regulatory Perspective
Friederike Heckmann
Ethics Commission, Medical Association Westfalen- Lippe, Germany
Follow up on Transitioned Clinical Trials from Ethics Committee Perspective
Have an account?