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