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January 22, 2020

United States and Japanese Stakeholders Discuss Cardiovascular Device Harmonization Activities at HBD Think Tank

January 22, 2020—On December 11, 2019, physicians, regulators, and industry members from the United States and Japan participated in the 2019 Harmonization By Doing (HBD) Think Tank in Tokyo, Japan. Since its initiation in 2003, the HBD collaboration has strived to promote United States–Japanese regulatory and clinical convergence by developing and piloting innovative and practical approaches to addressing shared real-world challenges affecting the evaluation and availability of cardiovascular devices in both countries. Lessons learned from these activities have been actively communicated to the cardiovascular community through publications, discussions at scientific symposia, and dedicated Think Tank workshops.

At the 2019 HBD Think Tank, HBD participants and other stakeholders discussed progress and next steps in three key areas of activity that impact both the United States and Japanese medical device ecosystems: pediatric device development, utilization of real-world clinical evidence for regulatory purposes, and facilitating early access to promising technologies. In addition, new projects involving non-cardiovascular devices, a multinational single-arm clinical study paradigm for coronary drug-eluting stents, and Good Clinical Practices (GCP) inspection pathways were discussed and supported. A detailed summary of the Think Tank discussions, along with slide presentations from the meeting, can be found on Japan’s Pharmaceuticals and Medical Devices Agency website here.

HBD plans for 2020 include scientific sessions at several US-based conferences, including the Cardiovascular Research Technologies (CRT) conference scheduled for February 22–25, 2020 in National Harbor, Maryland; the Transcatheter Cardiovascular Therapeutics (TCT) conference scheduled for September 23–27, 2020 in Miami Beach, Florida; and the Vascular InterVentional Advances conference scheduled for November 2–5, 2020 in Las Vegas, Nevada. 

More information about HBD can be found here or by contacting the HBD Secretariat at hbd.contact@pmda.go.jp.

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