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[V6-S2] Paradigm Shift in Global Development Strategy - How to Utilize ICH E17 GL in New Drug Development? -
Session Chair(s)
Manabu Yanagisawa, PHD
Director, Global Scientific and Regulatory Affairs, Japan Pharmaceutical Manufacturers Association, Japan
The ICH E17 guideline is expected to reach Step 4 in 4Q 2017. This session will provide an opportunity to discuss how to utilize E17 appropriately, where global development strategy move toward, and what can be done to induce a change in our strategy. We have experienced so many evaluations of consistent or similar results among ethnic groups under E5 guideline and we know how difficult evaluation of ethnic differences and consistency among ethnic groups are. Given those experiences, this session will also address the points to consider in planning a global development program by means of E17, newly introduced pooling strategies (pooled region, pooled subpopulation), what kind of information is need for pooling, when such information to be obtained, how to present results from the Multi-Regional Clinical Trials. Those discussions would contribute to your readiness for the paradigm shift in global development strategy.
Speaker(s)
Nobushige Matsuoka, PHD
Group Lead, Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D Japan G.K., Japan
How should be the Future of Simultaneous Global Drug Development? - Road to Implementation of ICH E17 -
Masahiro Tohkin, PHD
Professor, Nagoya City University, Japan
Ethnic Differences on Efficacy and Safety in a Multi-Regional Clinical Trial
Koichi Miyazaki, PHD
Senior Director, Group IV, Oncology Clinical Development Department, Daiichi Sankyo Co., Ltd., Japan
The Impact of ICH-E17 on Clinical Development Strategy and Operations
Osamu Komiyama
CEO, Office Komiyama, Japan
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hiroshi Takeda, PHD, MS
Technical Officer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan