Dongmei Lu, PhD

Policy Lead, Office of Policy for Pharmaceutical Quality, OPQ, CDER

Dr. Dongmei Lu obtained her PhD degree in Pharmaceutical Sciences from University of North Carolina at Chapel Hill. She has pre-formulation and formulation working experience in GlaxoSmithKline, Wyeth and Pfizer. Before joining Office of Policy for Pharmaceutical Quality, she was a team leader in Office of Bioequivalence in Office of Generic Drugs. In OPPQ, Dongmei has been working on the policies of nitrosamine-impacted products. She was the primary author of the FDA guidance for industry “Control of Nitrosamine Impurities in Human Drugs”. Dongmei also led a couple of FDA sponsored research projects on nitrosamine mitigations. Dongmei serves as a member of PQRI Biopharmaceutics Technical Committee.

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