Pharmacovigilance

Is the science and activities relating to the detection, assessment, understanding and prevention of adverse events and any other drug-related problem (according to the definition of the WHO).

Risk Management Plans

Is the plan that defines the process by which risks factors are systematically identified, assessed and dealt with. Sometimes these plans are integrated conditions for Marketing Approval (MA), examples are the Post-Authorization Safety Studies (PASS) and Post-Authorization Efficacy Studies (PAES).

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