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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V4-S1] The Latest Topics over Development of Regenerative Medicine

Session Chair(s)

Akihiro  Umezawa, MD, PhD

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

Updates on Regenerative Medicine Product Regulations

Hiroshi Yaginuma, MPharm

Ministry of Health, Labour and Welfare (MHLW), Japan

Yoshihiro  Yoshikawa

The Practical Implementation of Regenerative Medical Products through the SAKIGAKE Designation System

Yoshihiro Yoshikawa

Nipro Corporation, Japan

General Manager, Research & Development Center for Regenerative Medicine

Kohji  Nishida, MD, PhD

TBC

Kohji Nishida, MD, PhD

Osaka University, Japan

Professor, Department of Ophthalmology

Kazunobu  Oyama, PhD

CMC Development Strategy of Regenerative Medical Products Assigned for Forerunner Review Assignment System "SAKIGAKE"

Kazunobu Oyama, PhD

Daiichi Sankyo Company, Limited, Japan

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