Yoshihiro Kikuchi has over 15 years of experience in the medical device industry. He has experience in a variety of therapeutic areas, including Endovascular, Neurovascular, Cardiovascular, Endoscopic therapy, and Oncology. His expertise covers all aspects of clinical research, including study design, set-up and execution of global studies, and developing approval and reimbursement strategies for medical devices in Japan. Yoshihiro also has extensive experience managing Japanese competent authority (PMDA and MHLW) submissions or projects.
Yoshihiro holds a BSc degree in Applied Mathematics and Statistics. He is instructor of the Japan fair trade council of the medical devices industry.
CORE COMPETENCIES
- Developing clinical strategy for approval and reimbursement in Japan
- Supporting Sponsors in the interaction with Japanese competent authority (PMDA and MHLW)
- Developing clinical study design including sample size calculation and statistical analysis
- Authoring Japanese Clinical Investigation Plan (CIP), Informed Consent Form (ICF), Case Report Form (CRF), Clinical Study Report (CER), and Clinical Section of Summary Technical Documentation (STED)
- Overseeing clinical study execution to ensure studies are completed on time, within budget and in compliance with SOPs, ICH/GCP guidelines, and Japanese regulations
RECENT PROJECTS
- Oversaw the successful completion of clinical study of a cardiovascular interventional medical device
- Oversaw a clinical trial and obtained regulatory approval and reimbursement for therapeutic endoscopic devices in Japan
- Multiple regulatory submissions and approvals in Japan based on clinical trial data conducted in the United States and Europe
PUBLICATIONS
- Yoshihiro Kageyama, Mabuchi Toshiro, Isao Tsuchii, Katsushi Kikuchi, Naofumi Masuda, Takayuki Uehira, Koutaro Akase, “Medical Device Regulatory Science Clinical Support Using Information Technology in Regulatory Science”, PHARM TECH JAPAN Vol.28 No.10 (2012) p141-145
- Co-author and Poster-session of “Efficacy and Safety of metformin for type-2 diabetic mellitus” at 126th Nihon yakugaku-kai
