What Students Need To Know About Risk Management in Pharmacovigilance.

Risk management in pharmacovigilance is undertaken to promote safe use of medicines and safeguard health of patients. It is a set of activities performed for identification of risk, risk assessment, and risk minimization and prevention. Risk management has the following stages: identification and characterization of the safety profile of the medicinal product; planning of pharmacovigilance activities to characterize risks and identify new risks; planning and implementation of risk minimization and mitigation and assessment of the effectiveness of these activities; and document postapproval obligations that have been imposed as a condition of the marketing authorization. All these activities together constitute the risk management plan, which is required to be submitted during the authorization of the drug. Marketing authorisation applicants are required to submit risk management plans (RMPs), which include information on a medicine’s safety profile and plans for pharmacovigilance activities designed to