Andrew Durfor

2014-2015

19

U.S. Department of Health and Human Services, U.S. Food and Drug Administration

Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labour and Welfare

Gain insight into the pressures and priorities that influence medical device regulation in Japan; with attention to the risk management elements used for foreign manufacturers. Additionally, increase mutual understanding of the inspection paradigm for determining compliance with applicable GMP/Quality System requirements in the United States and Japan with the goal of increasing cooperation and mutually satisfactory outcomes.