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S13 : The Direction of Review of Regenerative Medical Products ? From the Experiences of 10 Years and the Future ?
Session Chair(s)
Kiyoshi Okada, MD, PhD
Vice Director, Medical Ctr for Translational Research,Dept of Medical Innovation
Osaka University Hospital, Japan
Speaker(s)
Review Experience of 10th Anniversary Regenerative Medical Products
Shinichi Noda
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of Cellular and Tissue-based Products
Background and Direction of the Draft Evaluation Guidelines for Conditional & Term-limited Approvals and Subsequent Efficacy Follow-up Plans of Regenerative Medical Products
Yoji Sato, PhD
National Institute of Health Sciences, Japan
Head, Division of Drugs
Mitsuaki Chujo, PhD
AnGes, Inc., Japan
Director, Pharmacovigilance Department
Takashi Moritoyo, MD, PhD
The University of Tokyo Hospital, Japan
Professor, Head of Clinical Recerch Promotion Center