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4th DIA Cell and Gene Therapy Products Symposium in Japan

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SESSION 3 - Correspondence to Cartagena Law – Operation for Type 1 Use Regulations and Evaluation of Any Risks from Environmental Impact

Session Chair(s)

Eriko  Uchida, PhD

Eriko Uchida, PhD

  • Section Chief, Section 1, Division of Molecular Target and Gene Therapy Products
  • National Institute of Health Sciences, Japan
A procedure in conformity with so-called Cartagena law is to take on the occasion of development and the commercialization of gene therapy products in Japan. Among them, for the products used without taking containment measures, it is necessary to take the approval of the Type 1 Use Regulation by the Minister of Health, Labour and Welfare and to establish the operational condition aligned with the regulation in advance of the beginning of a clinical trial. In this session, we ask PMDA to explain the key points to note in the preparation of the application form and the biological diversity risk assessment report and help form a definite concept for the regulation. In addition, we also ask several presenters with such experiences from the companies and a medical institution to show their cases with problems and solutions and talk about the issues comprehensively as a panel discussion form.

Speaker(s)

Takami  Ishizuka, PhD

Outline of Mock-up of Type 1 Use Regulations and Points to Consider for Biological Diversity Risk Assessment Report

Takami Ishizuka, PhD

  • Reviewer, Office of Cellular and Tissue-basaed Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hiroshi  Miyashita, MSc, RPh

Operations by Company (Adeno-associated Virus (AAV))

Hiroshi Miyashita, MSc, RPh

  • Clinical Project Manager, Clinical Operations
  • Pfizer R&D Japan, Japan
Hiroyuki  Suda, MSc

Operations by Company (Adenovirus)

Hiroyuki Suda, MSc

  • VP, Clinical Development Strategy
  • KORTUC Inc., Japan
Masafumi  Onodera, MD, PhD

A Good Practice for the Cartagena Protocol in Clinical Sides

Masafumi Onodera, MD, PhD

  • Director, Center of Gene Cell Therapy Promotion,
  • National Center for Child Health and Development, Japan

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