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Pioneering Regenerative Medicine: Trends in Regulations for New Therapy

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
107

Room Number:
7B

Level:
Intermediate

Type:
Session

Title:
Pioneering Regenerative Medicine: Trends in Regulations for New Therapy

Chair(s):
Shinji Miyake, PhD
Professor, Center for Clinical Research
Keio University School of Medicine, Japan

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Application of iPS Cells to Retinal Diseases
Masayo Takahashi, MD, PhD
Project Leader, Laboratory for Retinal Regeneration
Riken Center for Developmental Biology, Japan

PMDA Perspective
Daisaku Sato, PhD
Director, Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

EMA Perspective
Dariusz Sladowski, MD, PhD
Member, EMA Committee on Advanced Therapies
Medical University of Poland, Poland