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Pioneering Regenerative Medicine: Trends in Regulations for New Therapy
Session Chair(s)
Shinji Miyake, PhD
Professor, Clinical and Translational Research Center
Keio University Hospital , Japan
This session will introduce the first clinical research of induced pluripotent stem (iPS) cell products in Japan. We will review the most updated regulatory status and governmental efforts surrounding regenerative medicine.
Learning Objective : Describe the planning of the first clinical research of induced pluripotent stem (iPS) cell products including the process of getting permission from the Japanese regulatory authority; Review the most updated regulatory status and governmental efforts surrounding regenerative medicine; Identify issues in the application of the new technology and discuss possible solutions.
Speaker(s)
Application of iPS Cells to Retinal Diseases
Masayo Takahashi, MD, PhD
Institute of Physical and Chemical Research (RIKEN), Japan
Project Leader of the Laboratory for Retinal Regeneration Research
PMDA Perspective
Daisaku Sato, PhD, MPharm, RPh
Ministry of Health, Labour and Welfare, Japan
Director, Compliance & Narcotics Division
EMA Perspective
Dariusz Sladowski, MD, PhD
Medical University of Warsaw, Poland
Member, EMA Committee on Advanced Therapies
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