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FDA Innovation in Pharmaceutical Quality Assessment and Inspection
Session Chair(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
FDA’s Office of Regulatory (ORA) and Office of Pharmaceutical Quality (OPQ) within CDER work closely together to provide “one quality for voice” for products including new drugs, biotechnology products, generic drugs, and over-the-counter drugs. Many changes and innovation have occurred since the 2015 stand up of OPQ and the 2017 program alignment within ORA. This session will discuss some of the innovative approaches being used within OPQ and ORA to provide more focused and patient relevant quality assessments, promote review efficiency and innovation for generic drugs and to integrate quality assessment and inspection.`
Learning Objective : Identify the ongoing FDA initiatives to modernize and integrate the quality assessment and inspection processes for drugs.
Speaker(s)
Modernization of Quality Assessment of Generic Drugs
Susan Rosencrance, PHD
FDA, United States
Acting Director, Office of Generic Drugs, CDER
Patient-Focused Quality Within OPQ: Clinically Relevant Specifications and Quality Overall Summary
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Progress in Integration of Inspection and Quality Assessment
Alonza Cruse
FDA, United States
Director, Office of Pharmaceutical Quality Operations, ORA, OGROP