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Tokyo Big Sight

Nov 15, 2015 9:30 AM - Nov 17, 2015 5:45 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

12th Annual Meeting DIA Japan 2015

The registrants will have access to presentation PDFs through Tuesday, May 17, 2016.

[V6-S1] The Difference between Pharmaceuticals and Medical Devices

Session Chair(s)

Kensuke  Ishii, PhD

Kensuke Ishii, PhD

Director, Office of Medical Devices I

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Since the Cabinet has approved to position the health care and medical field as one of major growth strategies of the Japanese government, it inevitably gives way to new entrants from different industries to the field and encourages innovative technology introduced for medical treatment. While a boundary between pharmaceuticals and medical devices is shown by the newly-enacted Pharmaceutical and Medical Device Act (PMD Act), combination products related to both areas have been actively developed and from a viewpoint of medical devices area there are some cases where pharmaceutical companies have difficulties in the development of such products due to a lack of knowledge about medical devices. In this session, we focus on the differences between pharmaceuticals and medical devices from various points of view and expect to improve understanding of the medical devices in the pharmaceutical industry.

Speaker(s)

Kazuo  Kawahara

The Difference between Pharmaceuticals and Medical Devices

Kazuo Kawahara

Terumo Corporation, Japan

General Manager, Clinical Development Department

Isao  Tsuchii

Bioreactionology for the Patient

Isao Tsuchii

Green Field, Japan

Business Operator

Yoshihiro  Muragaki, MD, PhD

The Difference between pharmaceuticals and medical devices from a standpoint of a clinician involved with development of photodynamic therapy

Yoshihiro Muragaki, MD, PhD

Kobe University, Japan

Prof, Center for Advanced Medical Engineering Research & Development (CAMED)

Koji  Ikeda, PhD

The Difference on Clinical trials

Koji Ikeda, PhD

Tohoku University Hospital, Japan

Professor, Clinical Research, Innovation and Education Center

Takashi  Ouchi

'Medical Devices and Pharmaceuticals' Comparison of approval review (reviewer’s point of view)

Takashi Ouchi

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office of Medical Devices I

Yuka  Suzuki, PhD

Yuka Suzuki, PhD

CRIETO Tohoku University Hospital, Japan

Special Appointment Professor

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