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[V2-S3] The Sakigake Designation System: Challenges and Points for Improvement
Session Chair(s)
Yoichi Sato, MPHARM
Quality and Safety Management Unit, Head, LTL Pharma 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.
Speaker(s)
Masayoshi Shibatsuji, MPHARM
Center for Research Administration and Support, National Cancer Center, Japan
The SAKIGAKE Designation System - Challenges from Regulatory Perspective -
Shigeki Shimasaki
Vice President & COO, Head of Research & Development, Nobelpharma Co., Ltd., Japan
Look Back on the SAKIGAKE - Lead to Successful OUTPUT -
Kenji Tsuchiya, MSC
Project Manager, Project Management Department, Shionogi & Co., Ltd., Japan
From the Experiences of Xofluza