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Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives
Session Chair(s)
John Poland, PhD
Regulatory Affairs Consultant
Association of Clinical Research Organizations (ACRO), United Kingdom
FDA and EMA guidance encourage a shift from 100% data verification to “fit for purpose” trial quality. Key concepts, metrics that allow trial oversight, and how trial quality can be reported and assessed will be addressed in this context.
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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