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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)
Masayo Takahashi, MD, PHD
Project Leader of the Laboratory for Retinal Regeneration Research, Institute of Physical and Chemical Research (RIKEN), Japan
Application of iPS Cells to Retinal Diseases
Daisaku Sato, PHD, MPHARM, RPH
Councilor for Pharmaceutical Affairs, Ministry of Health, Labour and Welfare, Japan
PMDA Perspective
Dariusz Sladowski, MD, PHD
Member, EMA Committee on Advanced Therapies, Medical University of Warsaw, Poland
EMA Perspective
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