Signal Detection and Management in Pharmacovigilance

Product licence holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance and they take risk minimisation action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources. This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection; signal validation; signal analysis and prioritisation; and risk assessment and minimisation.