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Session 7 - Update on Regulatory Schemes for Prompt Development and Accelerated Approval of Innovative Products
Session Chair(s)
Yoshiaki Maruyama, PhD
Review Director, Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Development of Advanced Therapies
Larissa Lapteva
FDA, United States
Associate Director, Division of Clinical Evaluation, OTAT, CBER
Advanced Therapy Regulations in Japan
Masaki Kasai, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Cellular and Tissue-based Products,
PMDA’s Efforts to Facilitate the Development for Innovative Drugs with High Medical Needs (SAKIGAKE Designation Scheme)
Kazuhiko Chikazawa
Japan Aegency for Medical Research and Development(AMED), Japan
Managing Director,Department of Innovative Drug Discovery and Development
Brief Overview of the Regulation of Advanced Therapies in China
Ling Su, PhD
Shenyang Pharmaceutical University, Yeehong Business School, China
Research Fellow
Accelerated Approval for early excess of innovative products
Se Eun Kim, MPH, RN
MFDS , Korea, Republic of
Director- Cell and Gene Therapy Products Division, NIFDS
Accelerating Drug Approval of Advanced Therapy
Ming-Mei Wu
TFDA, Taiwan
Deputy Director, Division of Medicinal Products
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