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[V4-S1] The Latest Topics over Development of Regenerative Medicine
Session Chair(s)
Akihiro Umezawa, MD, PHD
Deputy Director, National Center for Child Health and Development, Japan
This is the third DIA Japan Annual Meeting to present a session regarding development of Regenerative Medicine. Previously, the hot topics were understanding of the PMD Act (revised Pharmaceutical Affairs Law) and its practical use. This year, new systems like “SAKIGAKE (priority examination designation system)” and “Clinical Trials for Humanistic Perspective (Japan compassionate use)” were implemented to advance Regenerative Medicine development. This session will consider changes in the regulatory environment, the current state of Regenerative Medicine, and experienced challenges through discussion among health authorities, industry, and academia. Points to consider for effective development of regenerative medicine will also be explored.
Speaker(s)
Hiroshi Yaginuma, MPHARM
, Ministry of Health, Labour and Welfare (MHLW), Japan
Updates on Regenerative Medicine Product Regulations
Yoshihiro Yoshikawa
General Manager, Research & Development Center for Regenerative Medicine, Nipro Corporation, Japan
The Practical Implementation of Regenerative Medical Products through the SAKIGAKE Designation System
Kohji Nishida, MD, PHD
Professor, Department of Ophthalmology, Osaka University, Japan
TBC
Kazunobu Oyama, PHD
Senior Vice President, ONODERA GT Pharma, Inc., Japan
CMC Development Strategy of Regenerative Medical Products Assigned for Forerunner Review Assignment System "SAKIGAKE"
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