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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

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

Yil-Seob Lee, MD, PhD

Professor, Dept of Clinical Pharmacology

CHA Global clinical research center, CHA University, 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)

Tae Kyun  Nam, MPharm

Overview of Drug Regulation and Clinical Trials

Tae Kyun Nam, MPharm

Korean Ministry of Food and Drug Safety (MFDS) , Korea, Republic of

Deputy Director

Jeewon  Jeong, PhD

Regulatory Framework for Biosimilar Products in Korea

Jeewon Jeong, PhD

Korean Ministry of Food and Drug Safety (MFDS) , Korea, Republic of

Director

Kyung-Sang  Yu, MD, PhD

Government's R&D Investment Program

Kyung-Sang Yu, MD, PhD

Seoul National University , Korea, Republic of

Professor, Department of Clinical Pharmacology,

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