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Evaluation of the effectiveness of risk minimization measures

Before the introduction of risk management planning (RMP), pharmacovigilance was usually considered a series of process steps starting with data collection through signal detection, risk evaluation, action to protect public health, communication, and then evaluation of the effectiveness of the actions taken (a process step that was only rarely taken in practice). The introduction of RMP has ensured greater proactivity to pharmacovigilance and postauthorization benefit risk management. The final and perhaps most difficult step is the introduction of systematic evaluation of the effectiveness of risk minimization measures (RMM), thereby demonstrating public health protection.1