Tag: All about ICSR processing
Within this tag, you will discover a complete repository of information pertaining to ICSR (Individual Case Safety Report) cases, presented systematically from top to bottom at each level.
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Causality Assessment Simplified: Key Points
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.
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Assessing ADR-AE: From Source to Final Conclusion
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.
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Causality Assessment: The Toughest Tasks in Pharmacovigilance
This article explores the practical considerations, & common challenges involved in causality assessment, highlighting why it remains one of the toughest tasks.
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Concomitant Drugs in Pharmacovigilance: Why Accurate Documentation Matters
Concomitant medications are a constant reality in modern clinical practice and play a critical role in pharmacovigilance safety assessment. Let’s dive in.
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Concomitant Drug Coding: Getting It Right
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,…
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Pregnancy and Lactation: A Case Processing Perspective
This article explores the critical safety considerations surrounding pregnancy and lactation, highlights key distinctions in case assessment. Lets explore.
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Death vs Fatal vs Life-threatening
This article breaks down the terms such as death, fatal, and life-threatening are often used interchangeably—yet each carries a distinct regulatory meaning.
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Case Corrections in Pharmacovigilance
This blog explores what case corrections are, why they are necessary, and highlights common real-world examples every PV professional should know.
