UNIT 9: Causality Assessment
This unit explains how the relationship between a medicinal product and an adverse event is scientifically and clinically evaluated in Pharmacovigilance. It focuses on practical causality assessment approaches used in real PV settings, including structured scales and the role of medical judgment.
Causality assessment is the process of evaluating the likelihood that a medicinal product caused or contributed to an adverse event. In pharmacovigilance, the purpose of causality assessment is not to prove causation conclusively, but to support consistent evaluation of drug–event relationships for regulatory reporting, signal detection, and benefit–risk assessment.
Key Points
Assesses the relationship between drug and event.
Does not require absolute proof.
Supports regulatory and safety decisions.
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