Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including...
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Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading...
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Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
Christine Moore is Global Head and Executive Director, CMC Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA. Prior to working at FDA, Christine spent 10 years in small and large molecule process development. Throughout her career...
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Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Dr. Susan Rosencrance currently serves as the Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality of both brand name and generic drug...
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