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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)
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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