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[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
Professor, Institute of Advanced BioMedical Engineering and Science
Tokyo Women's Medical University, Japan
Akihiro Umezawa, MD, PhD
Deputy Director
National Center for Child Health and Development, Japan
Speaker(s)
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
Director, Compliance & Narcotics Division
Expectation and Challenge for“Regenerative Medical Product”Development from View of a Japanese Academia
Kiyoshi Okada, MD, PhD
Osaka University Hospital, Japan
Vice Director, Medical Ctr for Translational Research,Dept of Medical Innovation
Expectation and Challenges for Regenerative Medical Product Development: a Japanese biotech company’s perspectives
Kunihiko Suzuki
MEDINET Co., Ltd., Japan
Member of the Board
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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