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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 18, 2014 6:30 PM

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

11th Annual Meeting DIA Japan 2014

[V1-S6] Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law?

Session Chair(s)

Teruo  Okano, PHD

Teruo Okano, PHD

Professor, Institute of Advanced BioMedical Engineering and Science

Tokyo Women's Medical University, Japan

Akihiro  Umezawa, MD, PHD

Akihiro Umezawa, MD, PHD

Deputy Director

National Center for Child Health and Development, Japan

Speaker(s)

Daisaku  Sato, PHD, MPHARM, RPH

Exposition of New Regulation in theRevision of Pharmaceutical AffairsLaw -For Correct Understanding of“Conditional & Time Limited Approval”

Daisaku Sato, PHD, MPHARM, RPH

Ministry of Health, Labour and Welfare, Japan

Councilor for Pharmaceutical Affairs

Kiyoshi  Okada, MD, PHD

Expectation and Challenge for“Regenerative Medical Product”Development from View of a Japanese Academia

Kiyoshi Okada, MD, PHD

the University of Osaka & the University of Osaka Hospital, Japan

Professor , Deputy Director, Regenerative Medicine Support Office, Future Medica

Kunihiko  Suzuki

Expectation and Challenges for Regenerative Medical Product Development: a Japanese biotech company’s perspectives

Kunihiko Suzuki

MEDINET Co., Ltd., Japan

Member of the Board

Katherine  Tsokas, JD

Global Development of Regenerative Medicines: Opportunities for Accelerated Approval Pathways and Challengesof Global Development

Katherine Tsokas, JD

Janssen Research and Development, LLC, United States

Senior Director, Global Regulatory Affairs

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