Category: ICSR Management

Causality assessment is one of the most critical and challenging tasks in pharmacovigilance. It requires more than simply linking an adverse event to a drug.

Assessing ADR-AE (Adverse Drug Reactions and Adverse Events) are more than regulatory terminology—so it is necessary to report rightly. so here we explore.

This article explores the practical considerations, & common challenges involved in causality assessment, highlighting why it remains one of the toughest tasks.

Concomitant medications are a constant reality in modern clinical practice and play a critical role in pharmacovigilance safety assessment. Let’s dive in.

This blog features: Introduction Concomitant drugs are one of the most frequently coded elements in case processing, alongside the suspect drug. Despite their routine nature, they are also one of the most common sources of coding errors. Case processors often face uncertainty when selecting the correct drug code, especially when the reported information is incomplete,…

This blog explores what case corrections are, why they are necessary, and highlights common real-world examples every PV professional should know.

Drug indications might seem like a simple detail, but in PV case processing they can quickly become tricky. Let’s discuss in deeper.