REVIEW ARTICLE ON ADVERSE EVENT AND CASE PROCESSING IN PHARMACOVIGILANCE
Ms. Vaishnavi R. Kulwant, Ms. Pooja P. Ambhure, Dr. Sunil S. Jaybhaye, Ms. Varsha D. Lendal
Dr. Babasaheb Ambedkar Technological University, Raigad, Lonere, Maharashtra
Abstract
In pharmacovigilance the valid case consisting an identifiable reporter, identifiable patient, suspected product, adverse event, if any one of them is missing then it considered to be invalid case in Case processing. Pharmacovigilance (PV) Means detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It plays a Major role in ensuring the ongoing safety of medicinal products after they enter the market. The core of PV activities involves monitoring adverse events (AEs) and conducting efficient case processing to ensure patient safety and regulatory compliance.
Pharmacovigilance plays a pivotal role in ensuring the safety and effectiveness of medicinal products by systematically identifying, assessing, and preventing adverse drug reactions (ADRs). Adverse event (AE) reporting and case processing form the backbone of post-marketing surveillance, enabling early detection of safety signals. The process typically involves the collection of AE data from diverse sources such as healthcare professionals, patients, literature, and regulatory databases, followed by case validation, coding using standardized terminologies like MedDRA6, causality assessment, and expedited reporting to regulatory authorities. Efficient case processing ensures data accuracy, regulatory compliance, and timely communication of potential risks. Technological advancements, including automation, artificial intelligence, and real-world evidence platforms, are increasingly enhancing the quality and speed of pharmacovigilance activities. This article explores the critical components of AE reporting and case processing, highlights current challenges such as underreporting and data quality, and discusses evolving trends to strengthen global drug safety systems.
Keywords: Adverse Event, Spontaneous reporting, ICSR (Individual Case Safety Report), Duplicate check, MeDRa, causality assessment, Narrative writing.
Journal Name :
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EPRA International Journal of Research & Development (IJRD)
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Published on : 2025-11-29
| Vol | : | 10 |
| Issue | : | 11 |
| Month | : | November |
| Year | : | 2025 |