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Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program
Session Chair(s)
Yil-Seob Lee, MD, PHD
Professor
CHA Bundang Medical Center , Korea, Republic of
The Korean Ministry of Food and Drug Safety (MFDS) (formerly the KFDA) has evolved rapidly as one of the leading regulatory agencies in Asia, and the Korean government is initiating several R&D program to promote clinical development. This forum will discuss the current regulatory system and practices from the MFDS and government R&D program.
Learning Objective : Describe the current status of drug regulation and clinical trials in Korea and government R&D program; Discuss efficient way(s) to obtain IND approval and approval of biological products in Korea.
Speaker(s)
Overview of Drug Regulation and Clinical Trials
Tae Kyun Nam, MPHARM
Korean Ministry of Food and Drug Safety (MFDS) , Korea, Republic of
Deputy Director
Regulatory Framework for Biosimilar Products in Korea
Jeewon Jeong, PHD
Korean Ministry of Food and Drug Safety (MFDS) , Korea, Republic of
Director
Government's R&D Investment Program
Kyung-Sang Yu, MD, PHD, MBA
Seoul National University , Korea, Republic of
Professor, Department of Clinical Pharmacology,