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