A Review of Pharmacovigilance Aggregate Reporting: Recent Trends
DOI:
https://doi.org/10.69980/ajpr.v28i5.515Keywords:
Pharmacovigilance, aggregate reporting, drug safety, artificial intelligence, real-world data, regulatory guidelines, public health, data mining, trends, innovations.Abstract
Pharmacovigilance aggregate reporting plays a pivotal role in monitoring drug safety and supporting regulatory decision-making. This review examines recent trends in aggregate reporting, focusing on evolving methodologies, innovative technologies, and their applications in detecting and managing drug-related risks. Advancements such as data mining algorithms, artificial intelligence, and real-world data integration have transformed the field, enabling more efficient and accurate safety assessments. The review also highlights key regulatory guidelines and requirements at international and regional levels, offering insights into their impact on reporting practices. Challenges faced by stakeholders, including data quality, system interoperability, and resource limitations, are analyzed to provide a comprehensive understanding of existing barriers. Additionally, case studies and success stories demonstrate the positive influence of aggregate reporting on public health outcomes. The review concludes with actionable recommendations for improving pharmacovigilance systems and identifies critical areas for future research to enhance global drug safety surveillance.
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