What is Causality assessment in PV? Question - 17 Pharmacovigilance Interview Questions by Ramya. Watch all Interview Questions [ Ссылка ] . To know more details visit [ Ссылка ]
Question - 17: What is Causality assessment in
Pharmacovigilance and why is it needed?
Causality or relatedness assessment is the determination of whether there
is a reasonable possibility that the product is
causally related to the adverse event.
When a causal relationship is identified, then an adverse drug event (ADE) would be called an adverse drug
reaction (ADR).
Causality is the key factor for the identification of new signals,
measuring the strength of evidence, and in
evaluating the benefit-risk profile of pharmaceutical medicinal products.
