Artificial intelligence in pharmacovigilance signal management: a review of tools, implementations, research, and regulatory landscape.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-08-13 DOI:10.1080/14740338.2025.2545926

Maria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa

{"title":"Artificial intelligence in pharmacovigilance signal management: a review of tools, implementations, research, and regulatory landscape.","authors":"Maria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa","doi":"10.1080/14740338.2025.2545926","DOIUrl":null,"url":null,"abstract":"Introduction: The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex.Areas covered: This article presents available AI tools for signal management, provides an overview of the regulatory landscape of these tools, and explores stakeholder perspectives on the challenges and opportunities posed by AI regulations. On 23 July 2024, we conducted a Google search of the top 2,000 results using the query 'AI pharmacovigilance service provider.' Two searches were performed in Ovid MEDLINE to identify articles published between 1 January 2022, and 23 July 2024, using ad hoc queries.Expert opinion: AI tools are now available to support all critical activities in signal management. However, regulatory discrepancies and variations persist across different regions. The findings underscore the urgent need for ongoing international collaboration to harmonize regulatory frameworks and ensure the safe and ethical implementation of AI in PV. As AI technologies continue to evolve, addressing these regulatory and operational challenges will be essential to fully realize their potential in enhancing drug safety and improving healthcare outcomes worldwide.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-16"},"PeriodicalIF":3.1000,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14740338.2025.2545926","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex.

Areas covered: This article presents available AI tools for signal management, provides an overview of the regulatory landscape of these tools, and explores stakeholder perspectives on the challenges and opportunities posed by AI regulations. On 23 July 2024, we conducted a Google search of the top 2,000 results using the query 'AI pharmacovigilance service provider.' Two searches were performed in Ovid MEDLINE to identify articles published between 1 January 2022, and 23 July 2024, using ad hoc queries.

Expert opinion: AI tools are now available to support all critical activities in signal management. However, regulatory discrepancies and variations persist across different regions. The findings underscore the urgent need for ongoing international collaboration to harmonize regulatory frameworks and ensure the safe and ethical implementation of AI in PV. As AI technologies continue to evolve, addressing these regulatory and operational challenges will be essential to fully realize their potential in enhancing drug safety and improving healthcare outcomes worldwide.

查看原文本刊更多论文

药物警戒信号管理中的人工智能：对工具、实施、研究和监管环境的回顾。

近年来，人工智能（AI）与药物警戒（PV）的结合进展迅速。人工智能工具有可能通过实现更快、更准确的信号管理和决策来改变信号管理。然而，管理这些技术的监管环境仍然很复杂。涵盖领域：本文介绍了用于信号管理的可用人工智能工具，概述了这些工具的监管环境，并探讨了利益相关者对人工智能法规带来的挑战和机遇的看法。2024年7月23日，我们使用查询“人工智能药物警戒服务提供商”对前2000个结果进行了谷歌搜索。在Ovid MEDLINE中进行了两次搜索，以确定在2022年1月1日至2024年7月23日期间发表的文章，使用临时查询。专家意见：人工智能工具现在可用于支持信号管理中的所有关键活动。然而，不同地区的监管差异和差异仍然存在。研究结果强调，迫切需要进行持续的国际合作，以协调监管框架，并确保人工智能在光伏领域的安全和道德实施。随着人工智能技术的不断发展，应对这些监管和运营挑战对于充分发挥其在加强全球药物安全和改善医疗保健结果方面的潜力至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.