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Deborah F. Yaplee
MFP Year
2001-2003
MFP Class
7
Home State
Maryland
Home Agencies
U.S. Department of Health and Human Services, U.S. Food and Drug Administration
Host Agencies
Ministry of Health, Labour and Welfare, Pharmaceuticals and Medical Devices Agency
Objective
Learned about Japan's pre-marketing and post-marketing drug safety programs and the electronic submission of adverse events; examined how drug safety reports are collected and reported to regulatory agencies.