U.S-Japan Healthcare and Medical Device Exchange

January 24-30, 2009

Washington, D.C.

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U.S.-Japan Healthcare and Medical Device participants gather at the steps of Johns Hopkins University Medical Center.

Left to Right: Eri Kawabe, PMDA; Yuko Kitayama, PMDA; Mami Ho, PMDA; Yuzuru Okazaki, PMDA; Eriko Fukuda, PMDA; Masafumi Shimokawa, MHLW; Koji Ikeda, PMDA; and Yasuyuki Tabata, MHLW.

The Maureen and Mike Mansfield Foundation welcomed eight civil servants from Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) to Washington January 24-30, 2009 as part of a new exchange program. The U.S.-Japan Healthcare and Medical Device Exchange is bringing Japanese civil servants in the healthcare regulatory field to the United States to learn about U.S. healthcare policy and regulatory practices. During the January study trip, the Japanese participants met with their counterparts in the U.S. government, congressional staff, and U.S. healthcare professionals and engaged in information exchanges intended to contribute to the implementation of regulatory and health policies that promote innovation and favorable health outcomes.

Participants in this exchange included: Eriko Fukuda (Senior Reviewer, Pharmaceuticals and Medical Device Agency); Koji Ikeda (Deputy Review Director, Pharmaceuticals and Medical Device Agency); Yuko Kitayama (Professional Officer, Pharmaceuticals and Medical Device Agency); Mami Ito (Ho) (Reviewer, Pharmaceuticals and Medical Device Agency); Eri Kawabe (Professional Officer, Pharmaceuticals and Medical Device Agency);Yuzuru Okazaki (Reviewer, Pharmaceuticals and Medical Device Agency); Masafumi Shimokawa (Senior Technical Deputy Director, Ministry of Health, Labor and Welfare); andYasuyuki Tabata (Professional Officer, Ministry of Health, Labor and Welfare).

The program began with a site visit to the Johns Hopkins University Medical Center and the Johns Hopkins Bayview Medical Center, a state-of-the art medical facility in Baltimore. The visit included presentations and new technology demonstrations by Johns Hopkins physicians, attendance at a meeting of the medical center’s Institutional Review Board, and a tour of a research laboratory.

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Dr. Robert Weiss (left), John Hopkins Medical Center, discusses the importance of FDA regulation in trials.

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Dr. Halperin (left) demonstrates the inner workings of a John Hopkins’s produced catheter.

The delegation then participated in two days of briefings and dialogues at the U.S. Food and Drug Administration (FDA). There they learned about the FDA’s regulation of human tissue, cellular therapy, and combined products, and participated in roundtable discussions with alumni Mansfield Fellows Sema Hashemi (Mansfield Fellow 2006-2008) and Carole Carey (Mansfield Fellow 2003-2005) and with the Director of the Office of Combination Products and other FDA officials. The Japanese civil servants learned about the FDA’s history and evolving responsibilities and received an overview of the structure, function, and responsibilities of the FDA’s Center for Devices and Radiological Health. They later received an extensive tour of the FDA’s White Oak laboratory.

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FDA Deputy Commissioner Murray M. Lumpkin, addresses Healthcare and Medical Device participants during “FDA 101″

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Healthcare and Medical Device Participants receive FDA laboratory tour at the new White Oak facility.

The delegation also had the opportunity to meet with officials from the International Trade Administration at the Department of Commerce, industry policy experts, and staff in the office of Rep. Vic Snyder (D-Arkansas), who serves on several health-related caucuses.

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Masafumi Shimokawa, MHLW, discusses the differences between medical device regulation in the U.S. and Japan with Philip Agress (left) and Jeffrey Secunda (center) from AdvaMed.

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Chief of Staff David Boling (left), Office of Rep. Vic Snyder (AR), greets participants during a Capitol Hill discussion on healthcare.

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