Speakers

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.