• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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Patients Wait Less: Streamlining Regulatory Pathways for Cell/Gene Therapies in Asia-Pacific Region

Monday, June 03, 2024
Special Program
Cell and Gene Therapy and Genome Editing
28ABCDE
The growth pace for the development of cell and gene therapies in the Asia-Pacific region has been very rapid in recent years, only second to North America. Regulators recognize this emerging trend in dynamic research and development and have started developing regulatory frameworks and pathways to accommodate it. This session will be devoted to the comparison and discussion of the regulatory landscape for advanced therapies in different markets within the Asia-Pacific region and the marketing authorization procedures available in these markets as well as include perspectives from Japanese and Taiwanese regulators.
Moderator
Pi-Sheng Wang, M.D.
Deputy Minister
Ministry of Health and Welfare
Speakers
Akira Sakurai, PhD
Deputy Reviewer Director
Pharmaceuticals and Medical Devices Agency
Yueh-Ping Liu, M.D.
Director-General
Department of Medical Affairs, Ministry of Health and Welfare
Maggie Ho, Ph. D.
General Manager, Asian Business & CMC Regulatory Development
Amarex Clinical Research, LLC
Joseph Damond
Chair of Health Policy
Edelman Global Advisory
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