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ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation
Session Chair(s)
Pamela Tenaerts, MD, MBA
Chief Scientific Officer
Medable, United States
This forum will describe findings and interpretation of a multi-regional survey and in-depth interviews, conducted to inform appropriate renovation of ICH E6 GCP.
Learning Objective : Explain the results of a survey and in-depth interviews exploring issues and concerns related to ICH E6 (GCP); Discuss findings and insights based on results of multi-stakeholder, multi-regional, survey and in-depth interviews; Describe case studies illustrating obstacles in applying GCP to different types of trials and potential solutions.
Speaker(s)
Panelist
M. Khair ElZarrad, PHD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
Panelist
Janette Panhuis, BSN, MBA, RN
PHRI, Canada
Consultant
Panelist
Dagmar Goertz
Pfizer Pharma Gmbh, Germany
Director GCP Risk Management Lead