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ISCT Webinar - The New Regulatory Framework for Regenerative Medicine in Japan

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Description

ISCT Webinar: The New Regulatory Framework for Regenerative Medicine in Japan 

Organized by the ISCT Asia Regional Executive Committee

Chair:

  • Akihiro Shimosaka, PhD, Director, Research Foundation for Community Medicine, Tokyo, Japan

Speaker:

  • Kiyoshi Okada, MD, PhD, Associate Professor, Department of Medical Innovation, Osaka University Hospital, Osaka Japan

About the Webinar:

Regenerative medicine techniques use living tissues or cells to treat intractable diseases or reconstruct organs. With these techniques, however, there comes inherent risk, such as viral infection and tumorigenicity of stem cells. Thus, it is necessary for the regulation of regenerative medicine to evolve to meet the unique characteristics, particular to regenerative medicine. The government of Japan has made a nation-wide effort in preparation for innovative regenerative medicine, ensuring to promote research while also focusing on safety assurance. The regulatory guidelines for regenerative medicine have been reexamined and the (revised) Pharmaceutical Affairs Law (PAL), which was renamed as the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act), and the Act on the Safety of Regenerative Medicine were implemented in November of 2014 in Japan. Based on these recent changes in the national framework for regenerative medicine in Japan, we will introduce the current framework, outlining the significant changes and how it provides a breeding ground for cutting-edge, creative approaches to medicine based on innovative ideas, and ground-breaking research.

 

Learning Objectives:

  • Regulation for Medical Practice about Regenerative Medicine in Japan

  • Regulation for Regenerative Medical Products in Japan

  • Reimbursement for Regenerative Medical Products in Japan

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