EMA: Guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators - draft

Risk-minimisation measures are public-health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk-minimisation measures and assessing their effectiveness are key elements of risk management.

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