リスクマネジメント
Risk management is the discipline within pharmacovigilance that is responsible for signal detection and the monitoring of the risk-benefit profile of drugs. Other key activities within the area of risk management are that of the compilation of risk management plans (RMPs) and aggregate reports such as the Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), and the Development Safety Update Report (DSUR).