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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



[V2-S3] The Sakigake Designation System: Challenges and Points for Improvement

Session Chair(s)

Yoichi  Sato, MPharm

Yoichi Sato, MPharm

Associate Principal

JCR Pharmaceuticals Co., Ltd, Japan

The Sakigake Designation System was introduced in 2015 to provide innovative treatments to patients as early as possible. Pharmaceuticals, medical devices, in vitro diagnostics and regenerative medicines designated under the system are currently under development, and in 2017, two pharmaceuticals and one medical device received approval from PMDA. In this session, the challenges and points for improvement of the scheme will be discussed, based on the case studies of the approved products and by reviewing the approval and pricing procedures from the perspectives of the industry and regulatory authority.


Masayoshi  Shibatsuji, MPharm

The SAKIGAKE Designation System - Challenges from Regulatory Perspective -

Masayoshi Shibatsuji, MPharm

National Cancer Center, Japan

Center for Research Administration and Support

Shigeki  Shimasaki

Look Back on the SAKIGAKE - Lead to Successful OUTPUT -

Shigeki Shimasaki

Nobelpharma Co., Ltd., Japan

Vice President & COO, Head of Research & Development

Kenji  Tsuchiya, MSc

From the Experiences of Xofluza

Kenji Tsuchiya, MSc

Shionogi & Co., Ltd., Japan

Project Manager, Project Management Department