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Office of Pharmaceutical Quality Update
Session Chair(s)
Sarah Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States
This forum will discuss how the new structure of the Office of Pharmaceutical Quality (OPQ) further enhances CDER’s Good Manufacturing Processes (GMPs) for the 21st Century Initiative by creating an integrated drug quality program. As part of its mission, OPQ will streamline quality assessment throughout the product life cycle, including the integration of pre- and postapproval review, surveillance and inspectional functions.
Learning Objective : Describe the high-level structure and function of the newly established Office of Pharmaceutical Quality; Discuss additional details regarding the integrated quality assessment performed in OPQ; Identify forthcoming directions for OPQ in terms of policy and other initiatives.
Speaker(s)
One Quality Voice: Reality or Hype?
Janet Woodcock, MD
United States
Retired, Principal Deputy Commissioner, FDA
Integrated Quality Assessment
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Integrated Quality Assessment: The How and What of One Quality Voice
Giuseppe Randazzo, MS
Association for Accessible Medicines, United States
Vice President, Sciences and Regulatory Affairs
Panelist
Alonza Cruse
FDA, United States
Director, Office of Pharmaceutical Quality Operations, ORA, OGROP