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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
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)
Outline of Mock-up of Type 1 Use Regulations and Points to Consider for Biological Diversity Risk Assessment Report
Takami Ishizuka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Cellular and Tissue-basaed Products
Operations by Company (Adeno-associated Virus (AAV))
Hiroshi Miyashita, MSc, RPh
Pfizer R&D Japan, Japan
Clinical Project Manager, Clinical Operations
Operations by Company (Adenovirus)
Hiroyuki Suda, MSc
KORTUC Inc., Japan
VP, Clinical Development Strategy
A Good Practice for the Cartagena Protocol in Clinical Sides
Masafumi Onodera, MD, PhD
National Center for Child Health and Development, Japan
Director, Center of Gene Cell Therapy Promotion,
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