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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)
Prospect and Issues of Drug-Device Combination Products and Therapies
Yoshihiro Muragaki, MD, PhD
Kobe University, Japan
Prof, Center for Advanced Medical Engineering Research & Development (CAMED)
Development of “Radical Disinfection Device” for Treatment of Periodontitis -From Academia to Industry-
Keiichi Sasaki, DDS, PhD
Tohoku University School of Dentistry, Japan
Director, Tohoku University Graduate School of Dentistry / Dean,
PMDA’s Initiative for Introducing Innovative Medical Products
Masayoshi Shibatsuji, MPharm
National Cancer Center, Japan
Center for Research Administration and Support
Takehiko Arima
Takehiko Arima
Medtronic Japan Co., Ltd., Japan
Senior Director, Quality & Regulatory Affairs
Kazumichi Kobayashi, RPh
Kazumichi Kobayashi, RPh
Otsuka Medical Devices Co., Ltd., Japan
Executive Deputy President (Board Member)
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