Pharmacovigilance (PV)
PVThe 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.
Примеры
- FDA FAERS database for adverse event reporting
- EMA Periodic Safety Update Reports (PSURs)
- Uppsala Monitoring Centre (WHO global PV program)
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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, …