| Harmonization by Doing : A Systems Approach to Conducting Responsible Reserch (Clinical Development of Antithrombotic Agents in Japan, The 69th Annual Scientific Meeting of the Japanese Circulation Society) |
Sase K. Circ J 69(Supplemnt_I), 79 |
2005-03-01 |
| Harmonization by Doing (HBD) : Global Harmonization of Clinical Investigation and Research Infrastructure in Japan(Morning Lecture 2 (ML2) (H),The 70th Anniversary Annual Scientific Meeting of the Japanese Circulation Society) |
Sase K. Circ j, 70(Supplement_I), 96 |
2006-03-01 |
| FDA PERSPECTIVES ON GLOBAL TRIAL DEVELOPMENT FOR MECHANICAL CIRCULATORY SUPPORT DEVICES: INTERMACS AND HARMONIZATION BY DOING PROGRAMS |
Chen E. Journal of the Japanese Society for Artificial Organs and Tissues. 36(2Supplement), s1-s1 |
2007 |
| Comparing GCP Requirements for Medical Device Clinical Trials in the US and Japan |
Harmonization-by-Doing Working Group 4. RAPS Journal April 2010 |
2010 |
| Current Trend of Reviewing and Regulation for Medical Devices : Complementary Approach with Global Regulatory Harmonization by GHTF and Practical International Clinical Trial by HBD [in Japanese] |
Sase K. Jpn. J. Clin. Pharmacol. Ther. 41(4), 133-139 |
2010-07-31 |
| Harmonization by Data (HBD): Initial Experience with a Post-Marketing follow-up Study of Mechanical Circulatory Assist Devices (J-MACS), and Ongoing Collaborations with Academic Research Consortiums. [in Japanese] |
Sase K. Pharmaceutical and Medical Device Regulatory Science, 43(4), 339-346 |
2012 |
| The First-ever Report on Multi-Company Survey of the Cost of Medical Device Clinical Trials in Japan : Results of a Collaborative Study [in Japanese] |
Kouzaki Y, Fukuzawa I, Akabori M, et al. Pharmaceutical and Medical Device Regulatory Science, 43(5), 452-463 |
2012 |
| GCP Convergence Improves Transportability of Medical Device Clinical Data |
Harmonization-by-Doing Working Group 4. RAPS Regulatory Focus January 2013 |
2013 |
| Summary Technical Documentation (STED):Harmonizing a Predictable Regulatory Submission |
Harmonization-by-Doing Working Group 4. RAPS Regulatory Focus September 2013 |
2013 |
| Global Cardiovascular Device Innovation : Japan-USA Synergies : Harmonization by Doing (HBD) Program, a Consortium of Regulatory Agencies, Medical Device Industry, and Academic Institutions |
Uchida T, Ikeno F, Ikeda K et al. Circ J, Volume 77 (2013) Issue 7 Pages 1714-1718 |
2013 |
| Rationale and design of the Japan-USA harmonized assessment by randomized, multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a novel DES platform for percutaneous coronary revascularization in patients with ischemic coronary disease and non–ST-elevation acute coronary syndrome |
David F. Kong, MD, Shigeru Saito, MD, Shigeru Nakamura, MD, Roxana Mehran, MD, Stephen M. Rowland, PhD, Allison Handler, MHSc, Hussein R. Al-Khalidi, PhD, and Mitchell W. Krucoff, MD: Am Heart J 2017;187:112-121 |
2017 |
| Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents |
Murakami M, Suzuki Y, Tominaga T. - Circ J. 2018 Feb 23;82(3):636-643 |
2018 |
| Japanese registry for Mechanically Assisted Circulatory Support: First report. |
Nakatani T, Sase K, Oshiyama H, et al. The Journal of Heart and Lung Transplantation. Volume 36, Issue 10, October 2017, Pages 1087-1096 |
2017 |
| Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) |
Hiroyoshi Yokoi, Mami Ho, Shin Iwamoto, Yuka Suzuki, Gary M. Ansel, Nobuyoshi Azuma, Nobuhiro Handa, Osamu Iida, Koji Ikeda, Fumiaki Ikeno, Norihiko Ohura, Kenneth Rosenfield, John Rundback, Hiroto Terashi, Takahiro Uchida, Yoshiaki Yokoi, Masato Nakamura, Michael R. Jaff: - A Joint USA-Japanese Perspective -. Circ J 2018; 82: 2233 – 2239 |
2018 |
| Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective |
Cavanaugh K, Buckley D, Malone M. Circ J October 2018 |
2018 |
