Staff｜Medical Device Development Support Group

INTRODUCTION

Tomohito Suzuki, Ph.D

Tomohito worked at the Pharmaceuticals and Medical Devices Agency (PMDA) for 12 years, where He was engaged in approval review and consultation services, mainly for cardiovascular medical devices.
During his tenure at PMDA, he transferred to the University of Tokyo Hospital and the Japan Agency for Medical Research and Development (AMED), where he was in charge of R&D support for medical devices and management and operation of budget projects.

Yuki Otsuka

Yuki worked at the Clinical Research Innovation and Education Center Tohoku University Hospital for 5 years since April 2015.
He was in charge of consultation support to PMDA for medical devices and pharmaceuticals, project management of investigator-initiated clinical trials and clinical research, and supported for obtaining public funds from AMED and other sources.

Ayako Tokue

Ayako worked at medical device manufacturer for 6 years, where she was engaged in R&D, mainly for cardiology. Later, she worked at the Clinical Research Innovation and Education Center Tohoku University Hospital for 8 years, where she was in charge of consultation support to PMDA and project management of investigator-initiated clinical trials for medical devices.

Ai Tanaka

Ai worked at the Pharmaceuticals and Medical Devices Agency (PMDA) for 8 years, where she was engaged in approval review and consultation services, mainly for ophthalmology-related medical devices.
For 2 years from 2018, she worked at the Clinical Research Innovation and Education Center Tohoku University Hospital, where she was in charge of supporting the preparation of consultation materials and approval application materials to the PMDA.

Natsu Fujiki

Natsu worked as a clinical development monitor for pharmaceuticals at a CRO for 2 years. After that, she worked at the Clinical Research Innovation and Education Center Tohoku University Hospital for 2 and a half years, where Natsu was in charge of consultation support to PMDA and project management of investigator-initiated clinical trials for medical devices and in vitro diagnostic products.

Chie Kayaba

Chie worked as a nurse at Tohoku University Hospital and other hospitals before working as a clinical trial coordinator at a SMO for about 8 years. After that, She worked at the Clinical Research Innovation and Education Center Tohoku University Hospital for 8 years, where she was in charge of project management and study management for investigator-initiated clinical trials for medical devices and pharmaceuticals.