返回 Agenda
[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)
The SAKIGAKE Designation System - Challenges from Regulatory Perspective -
Masayoshi Shibatsuji, MPharm
National Cancer Center, Japan
Center for Research Administration and Support
Look Back on the SAKIGAKE - Lead to Successful OUTPUT -
Shigeki Shimasaki
Nobelpharma Co., Ltd., Japan
Vice President & COO, Head of Research & Development
From the Experiences of Xofluza
Kenji Tsuchiya, MSc
Shionogi & Co., Ltd., Japan
Project Manager, Project Management Department