Safety Science 2: Safety Surveillance, Pharmacoepidemiology, Risk

Addresses advanced concepts in the United States and global safety surveillance—the increasingly significant areas of surveillance, pharmacoepidemiology, and risk management. Offers students an opportunity to become familiar with basic concepts in clinical pharmacology, epidemiology, and data analysis (including data mining) relevant to surveillance and risk management. Addresses study design for pharmacoepidemiologic studies, risk management (including premarketing risk assessment and RiskMAPs), and vigilance planning. Includes an examination of global surveillance efforts, including the roles of the FDA, EMEA, ICH, CIOMS, and the Uppsala Monitoring Centre. Prereq. RGA 6212.

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