RESEARCH

Keywords

• Regulatory Science
• Clinical Pharmacology
• Clinical Evaluation of Medical Devices
• Global Regulatory Harmonization
• Cardio-oncology

Main Research Topics and Interests

• International Consortium for Cardiovascular Registries (ICCR)
• US-Japan Harmonization by Doing (HBD)
• Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS)
• Distributed Data Model and Unique Device Identifier (UDI)
• In Vitro Diagnostics and Molecular Biomarkers for Precision Medicine

Publications (in English)

• Original Articles (25) <Total Impact Factor: 100.1, Citations: 1,245, Citation Index: 49.8>>
• Review Articles (2) <Total Impact Factor: 3.6, Citations: 70, Citation Index: 35.0>>
• Books (3)

Recent Main Publications

• Kataoka Y, Yasuda S, Miyamoto Y, et al: Clinical Predictors of Atheroma Progression Despite Optimal Glycemic Control in Early-Stage Diabetic Patients with Coronary Artery Disease: Insight from the DIANA Study. J Atheroscler Thromb, 2014; 21; 509-518.
• Kamide K, Asayama K, Katsuya T, et al: Genome-wide Response to Antihypertensive Medication Using Home Blood Pressure Measurements: A Pilot Study Nested within the HOMED-BP Study. Pharmacogenomics, 2013; 14; 1709-1721.
• Kataoka Y, Yasuda S, Miyamoto Y, et al: Effects of Voglibose and Nateglinide on Glycemic Status and Coronary Atherosclerosis in Early-Stage Diabetic Patients. Circ J, 2012; 76; 712-720.
• More

Other Specific Comments

Global Regulatory Harmonization and Related Activities

2005-

Steering Committee, US-Japan Harmonization by Doing (HBD).

2005-2012

Study Group 5 (Clinical Evaluation), Global Harmonization Task Force (GHTF).

2006-2013

Co-chair, Working Group 2 (Post-Markting Registry of Medical Devices). US-Japan Harmonization by Doing (HBD)

Japanese Government/Academic Committee Responsibilities

2001-2003

Project member, Translational Research Informatics Center. City of Kobe

2003-2005

Technical Advisory Committee, Japanese Medical Association Center for Clinical Trials (JMACCT)

2005-2005

Working Group, High-Speed IP Handover for Mobile Telemedicine to Support Pre-Hospital Care and Emergency Medicine. Kinki Bureau of Telecommunications. Ministry of Internal Affairs and Communications

2005-2006

Senior Research Fellow (Imura-Group/Proposal for National Policy on Clinical Research), Center for Research and Development Strategy, Japan Science and Technology Agency (CRDS/JST)

2006-2007

Group on Implantable Mechanically Assisted Circulatory Support. Committee for Evaluation of Next-Generation Medical Devices, National Institute for Health Sciences, Ministry of Health, Labour, and Welfare

2006-

External Advisory Board Member, Pharmaceuticals and Medical Devices Agency (PMDA)

2007-

Operational Committee, Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS). Pharmaceuticals and Medical Devices Agency (PMDA)

2007-

Steering Committee, Japanese Regisry for Mechanically Assisted Circulatory Support (J-MACS), Pharmaceuticals and Medical Devices Agency (PMDA)

2008-

Senior Member, Division of Regulatory Sciences, The Pharmaceutical Society of Japan

2009-2009

Advisory Board to the Committee on Health Research Initiatives, Cabinet Office

2012-

Reviewer. Program to Develop Medical Equipment and Devices to Solve Unmet Medical Needs, Ministry of Economy, Trade and Industry

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