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Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three stages:
• Characterization of the safety profile of the medicinal product
• Planning of pharmacovigilance activities to identify and characterize risks
• Risk minimization and mitigation, assessment of the effectiveness of these activities
The set of risk management activities and interventions is called the Risk management System.
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