Assessing Labelling, Listedness, Expectedness in Pharmacovigilance

Assessing Labelling, Listedness, Expectedness in Pharmacovigilance: Differences & Methodology used in assessment

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

This concept involves determining whether any adverse drug reaction or adverse drug event is already known/already documented/already observed in subjects/patients who are under treatment with the investigational/marketed medicinal product. It determines the expeditious nature of an ICSR (Individual case safety report) by formulating the regulatory due timeline for submission to health authority (7/15 days). For…

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Causality Assessment in Pharmacovigilance

Causality Assessment in Pharmacovigilance: Concept & Methods

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

Causality Assessment: Causality is an assessment procedure used for the determination of relationship between a drug treatment and the occurrence of an adverse drug event. When a causal relationship is identified, then adverse drug event (ADE) would be called as adverse drug reaction (ADR). The assessment of causality is a common procedure in pharmacovigilance, which…

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Drug Safety: Aggregate reporting -An overview on types, regulatory timelines and requirements

Aggregate report writing, Pharmacovigilance

The periodical reporting of aggregate safety reports to regulatory health authorities includes a comprehensive overview of the safety profile of medicinal product based on cumulative safety information accumulated by Marketing Authorization Holder (MAH). They also provide assurance that the MAH is continuously monitoring and critically assessing the benefit-risk profile of the product and taking appropriate…

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