Pharmacovigilance (PV)

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems throughout the lifecycle of a medicinal product. Encompasses spontaneous reporting, signal detection, risk-benefit analysis, and risk management. Defined by WHO and regulated under ICH E2E guidelines for pharmacovigilance planning.

Exemples

• FDA FAERS database for adverse event reporting
• EMA Periodic Safety Update Reports (PSURs)
• Uppsala Monitoring Centre (WHO global PV program)