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Session Chair(s)
John Poland, PHD
Regulatory Affairs Consultant
Association of Clinical Research Organizations (ACRO), United Kingdom
Learning Objective : Apply the concept of "fit for purpose" quality to a risk-based clinical trial monitoring model; Develop suitable metrics for the measurement and assessment of "fit for purpose" trial quality.
Speaker(s)
EMA Perspective
Anabela Marcal, PHARMD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
FDA Perspective
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
Industry Perspective
Mike Sobczyk, MSC
Gilead Sciences, Inc., United States
Exec. Director, R&D Quality and Compliance
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