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Introducing CDER's Office of Pharmaceutical Quality

Track:
Pharmaceutical Quality

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
273

Room Number:
6C

Level:
Basic

Type:
Session

Title:
Introducing CDER's Office of Pharmaceutical Quality

Chair(s):
Christine M. V. Moore, PhD
Acting Director, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States

Description:
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(s):
Discuss the mission and function of CDER's proposed Office of Pharmaceutical Quality; Describe examples of risk-based decision making in regulatory approaches.

Presentation(s) & Speaker(s):
Pharmaceutical Quality for the 21st Century: The Next Chapter
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
FDA, United States

Quality Metrics in the Office of Pharmaceutical Quality
Russell Wesdyk, MBA
OPS Scientific Coordinator, Office of Strategic Programs, CDER
FDA, United States