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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Record Drug Indications in PV Cases Processing
Drug indications might seem like a simple detail, but in PV case processing they can quickly become tricky. Let’s discuss in deeper.
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Pregnancy reports: Paternal and Maternal
In this article, Pregnancy-related cases in pharmacovigilance present unique challenges, requiring careful assessment of both paternal and maternal exposures.
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Causality Assessment: Selection and Prioritize the Cases
This article explores how to effectively select and prioritize cases for causality assessment, with a special focus on serious and AEFI-related reports.
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Adverse Event Coding: Signs and Symptoms
This blog covers: Introduction Pharmacovigilance coding involves several complex and often confusing areas, including indications, adverse events, and current conditions. In this article, we will explore how signs, symptoms, and adverse events are identified, evaluated, and coded into a safety database, along with best practices for accurate and consistent reporting. Signs and symptoms: An overview…
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Warnings and Precautions: Key Insights from Safety Documents
This article explores how the Warnings and Precautions section of safety documents plays a critical role in this process. Let’s dive in and explore.
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Action Taken and Outcome: Explained
This comprehensive blog will guide you through the fundamentals of “action taken” in case files and its impact on patient outcomes, highlighting their interrelation.
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Condition aggravated: A scenario
Understanding how to handle condition aggravated as reported as an adverse event is a common challenge in pharmacovigilance case processing. Let’s dive in.
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Current and Non-Current LLTs in MedDRA
This comprehensive artcile detailed article explained often overlooked but essential for quality data in MedDRA coding. That is Current and Non-Current LLTs.
