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[Session 1] Expedited Review Pathways in Asia
Session Chair(s)
Masayoshi Shibatsuji, MPharm
Center for Research Administration and Support, National Cancer Center, Japan
Earlier access to new drugs has recently been realized as a result of improved regulations to approve new drugs earlier at the global level. In this session, Asian regulatory experts will explain expedited review pathways in each region, followed by a panel discussion, to deeply discuss various strategies that deliver innovative new drugs earlier to patients in Asia.
Speaker(s)
Kyungtak Nam, PhD
Senior Scientific Officer, Biopharmaceuticals Review Management Division, NIFDS, Ministry of Food and Drug Safety, Korea, Republic of
Expedited Pathways for Biopharmaceuticals in Korea
Lien-Cheng Chang, PhD
Senior Secretary, Department of Intellectual Property and Technology Transfer, Academia Sinica, Taiwan
Expedited Review Process and Timeline (TFDA)
Xiaojun (Wendy) Yan, MD, MBA
Strategic Advisor, DIA BOD, China
Expedited Program in China
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