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Introducing CDER's Office of Pharmaceutical Quality
Session Chair(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards, Organon & Co., United States
This session will describe the mission and function of CDER's proposed Office of Pharmaceutical Quality with a focus on risk-based regulatory decision making. CDER is proposing a reorganization of quality related functions into a single Office of Pharmaceutical Quality (OPQ), based on the following principles: Risk-based resource management and decision making, maximal development and utilization of staff expertise, proactive view of product quality through quality surveillance; and enhanced integration of review and inspectional functions.
You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “CDER Office of Pharmaceutical Quality” in the subject line.
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)
Janet Woodcock, MD
Retired, Principal Deputy Commissioner, FDA , United States
Pharmaceutical Quality for the 21st Century: The Next Chapter
Russell Wesdyk, MBA
Acting Director, Office of Surveillance, OPQ, CDER , FDA, United States
Quality Metrics in the Office of Pharmaceutical Quality
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