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[V4-S1] Let’s Think about Drug/Device Combination Use for Treatment
Session Chair(s)
Kensuke Ishii, PHD
Director, Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Drug-device combination products and therapies are currently the subject of much attention given the increasing difficulties in developing truly innovative new pharmaceuticals and medical devices. This session focuses on clinical development issues with regard to combination products or therapies by discussing a number of concrete examples. The session will include a discussion of how to manage the simultaneous development of devices and pharmaceuticals more efficiently and how various hurdles and issues during clinical development could be potentially addressed.
Speaker(s)
Yoshihiro Muragaki, MD, PHD
Prof, Center for Advanced Medical Engineering Research & Development (CAMED), Kobe University, Japan
Prospect and Issues of Drug-Device Combination Products and Therapies
Keiichi Sasaki, DDS, PHD
Director, Tohoku University Graduate School of Dentistry / Dean, , Tohoku University School of Dentistry, Japan
Development of “Radical Disinfection Device” for Treatment of Periodontitis -From Academia to Industry-
Masayoshi Shibatsuji, MPHARM
Center for Research Administration and Support, National Cancer Center, Japan
PMDA’s Initiative for Introducing Innovative Medical Products
Takehiko Arima
Senior Director, Quality & Regulatory Affairs, Medtronic Japan Co., Ltd., Japan
Kazumichi Kobayashi, RPH
Executive Deputy President (Board Member), Otsuka Medical Devices Co., Ltd., Japan
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