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Session Chair(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
Learning Objective : Discuss the mission and function of CDER's proposed Office of Pharmaceutical Quality; Describe examples of risk-based decision making in regulatory approaches.
Speaker(s)
Pharmaceutical Quality for the 21st Century: The Next Chapter
Janet Woodcock, MD
United States
Retired, Principal Deputy Commissioner, FDA
Quality Metrics in the Office of Pharmaceutical Quality
Russell Wesdyk, MBA
FDA, United States
Acting Director, Office of Surveillance, OPQ, CDER
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