Dr. Yeowon Sohn

Dr. Yeowon Sohn is currently a professor of School of Pharmacy at Sungkyunkwan University in Korea. Before joining the university, she had served during 2015-17 as Director-General of National Institute of Food and Drug Safety Evaluation (NIFDS), a subsidiary of Ministry of Food and Drug Safety (MFDS), Republic of Korea. As the head of NIFDS, she worked on enhancing scientific expertise and designing policies for the agency to carry out its mission of ensuring the safety of food and drugs in Korea. In particular, she provided executive oversight, strategic leadership, and policy directions to fulfill NIFDS’s responsibility, which is to assure the safety and effectiveness of medicinal products (drug, biologics, and medical devices including in vitro diagnostics). She was also engaged in facilitating global data sharing, development, and harmonization of medicinal standards. During 2020-2021 she was the president of the Korean Society of Food, Drug and Cosmetics Regulatory Sciences. And she also served as a member of the Committee on Health and Medical Service Technology of the Ministry of Health and Welfare (MOHW), Republic of Korea.

Dr. Yeowon Sohn has more than twenty-seven years of experience in regulating the biological products including vaccines and blood products, recombinant therapeutic proteins, gene and cell therapy products. Until her appointment as D-G of NIFDS in 2015, she served as the Director of Biopharmaceutical and Herbal Medicines Evaluation Department of NIFDS since December 2010.

Dr. Sohn received Ph.D. degree in Pharmacy (Biochemistry) from Seoul National University in 1989. She was granted a postdoctoral fellowship in McArdle Laboratory at University of Wisconsin, USA (1992-1993). During this period she researched on molecular carcinogenesis.

Since joining the KFDA (Korea Food and Drug Administration, which became MFDS in 2013) in 1990, she has been actively involved in standardization of biological products at the global level. She was trained in National Institute of Biological Standardization and Control, UK in 1997 and worked at WHO as a scientist in 2003 for evaluation of prequalification of vaccines. Since then she became one of key players of WHO biological standardization program. She has participated in many WHO guidelines development. Especially, she served as a drafting group member of developing WHO guidelines for similar biotherapeutic products which was published in 2010. And she has been an expert panel member of WHO ECBS (Expert Committee on Biological Standardization) since 2011. She served as an expert committee member of United States Pharmacopoeia (USP) for biological and biotechnological products from 2010 to 2015. She chaired International Pharmaceutical Regulator’s Forum (IPRF) Biosimilars Working Group from 2013 to 2015. She also has been Director of APEC Harmonization Center and WHO Collaborating Center in biological standardization since 2015.