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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)
Expedited Pathways for Biopharmaceuticals in Korea
Kyungtak Nam, PhD
Ministry of Food and Drug Safety, Korea, Republic of
Senior Scientific Officer, Biopharmaceuticals Review Management Division, NIFDS
Expedited Review Process and Timeline (TFDA)
Lien-Cheng Chang, PhD
Academia Sinica, Taiwan
Senior Secretary, Department of Intellectual Property and Technology Transfer
Expedited Program in China
Xiaojun (Wendy) Yan, MD, MBA
BeiGene (Beijing) Co., Ltd., China
Senior Vice President, Chief Regulatory Officer
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