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Student Session: Global Clinical Development and Benefit-risk Assessment ~ (Japanese Language Only)
Session Chair(s)
Eisuke Nakata, MSc
Clinical Trial Lead, Cardiovascular, Dept. of Clinical Management
Otsuka Pharmaceutical Co., Ltd., Japan
Yuya Shizume
Graduate Student
Musashino University, Japan
Misa Waraya, MPharm
Daiichi Sankyo Company, Limited, Japan
Ryuta Yoshida
Regulatory Affairs Department
NIDEK Co. Ltd., Japan
Student Session is the open place for students who are interested in development of pharmaceutical products to get together and learn about drug development through interaction with people from industry, regulatory and academia. It could be a great opportunity for students to develop their knowledge and skill to be a future leader. // In this session, we will get two lectures. One is about Global Clinical Development, and the other is how to consider Risk and Benefit of pharmaceutical products with several cases. After the lectures, we are going to gain more understanding about these themes by group discussion among students, presentation and feedback each other. // Another aim of this session is to get business skills such as communication skill that are required for global leaders.
Speaker(s)
Drug Evaluation in Japan Local Development and Global Development
Yoshiko Komuro, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspection Director, Office of Non-Clinical and Clinical Compliance
Benefit & Risk Assessment - Several Approaches
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
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