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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V6-S1] Challenges and Issues to Product Development for Gene Therapy

Session Chair(s)

Masafumi  Onodera, MD, PhD

Masafumi Onodera, MD, PhD

Director, Center of Gene Cell Therapy Promotion,

National Center for Child Health and Development, Japan

In recent years, the development of products for genetic therapy became popular all over the world, and concrete discussions on commercialization have been carried out recently in Europe and US. On the other hand, in using genetically modified products, Japan and the EU have ratified the Cartagena Protocol, and in Japan it is necessary to consider environmental impacts on biosafety based on regulations by Japan original law. In this session, we focus on the differences in the system of Japan, the US and Europe, and discuss the point to be cleared for conducting clinical trials in Japan when we submit the Cartagena Law type 1 usage application. We discuss issues to be considered for future practical application.


Teruhide  Yamaguchi, PhD

Comparison of Regulations on Biosafety in Japan, the US and Europe and Issues in Japan

Teruhide Yamaguchi, PhD

Kanazawa Institute of Technology, Japan

Professor Director, Institute of Advance Medical and Engineering

Hiroyuki  Suda, MSc

Points to Consider in the Cartagena Law Type 1 Usage Application (Point of View from a Company)

Hiroyuki Suda, MSc

KORTUC Inc., Japan

VP, Clinical Development Strategy

Kazunobu  Oyama, PhD

Points to Consider for Creating Cartagena Type 1 Usage Application (From PMDA Point of View)

Kazunobu Oyama, PhD

Daiichi Sankyo Company, Limited, Japan