Nam-Hee Lee,

Council of Regulators
Ministry of Food and Drug Safety Liaison to the DIA Board

Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety

Dr. Nam-Hee Lee serves as Director of the Clinical Trials Management Division, Ministry of Food and Drug Safety (MFDS), in the Republic of Korea. She manages all aspects of clinical and non-clinical trials including policy establishment; regulation and protocol approvals; BA/BE protocol and study approvals; GCP compliance inspections; BE/non-clinical/clinical facility qualification; and test animal facility management.

Dr. Lee is a trained pharmacist and joined MFDS in June 1996 after earning her Ph.D. She has worked for the MFDS and the Ministry of Health and Welfare (MoHW) for over 20 years, in various roles. At MFDS, Dr. Lee has served in the Pharmaceutical Policy Division, the Pharmaceutical Approval and Management Division, and as Director of the Cosmetic Policy and Pharmaceutical Approval and Patent Management Divisions. She has also served in the Pharmaceutical Policy Division/Office for Healthcare Policy at the MoHW.

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