基于风险的方法安全案例后续的不良事件报告在药物监督
Ganesh Kumar Vemula1, Pavan Badale2, Petros Mavrogenis3
1Patient Safety and Pharmacovigilance, Development, Novartis Pharma AG, Hyderabad, India. ganesh_kumar.vemula@novartis.com.
Advances in therapy
|November 3, 2023
概括
这项研究分析了营销许可证持有人 (MAH) 对不良事件 (AE) 报告的后续行动,检查了大流行前个人病例安全报告 (ICSR) 的基于风险的方法. 结果为优化安全数据收集和监管讨论提供了见解.
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 分析健康数据 分析健康数据
背景情况:
- 营销许可证持有人 (MAH) 管理不良事件 (AE) 报告,包括个人病例安全报告 (ICSR).
- 目前ICSR的后续策略往往是资源密集的.
- 建议采用基于风险的方法来进行ICSR跟踪,以提高效率和有效性.
研究的目的:
- 分析AE报告的后续行动尝试的特点和结果.
- 评价基于风险的方法的应用,以ICSR的随访由持有者.
- 提供数据支持行业和监管对话关于ICSR后续程序.
主要方法:
- 来自欧洲经济区 (EEA) 疫情前的ICSR数据的描述性统计分析.
- 检查了一年后的随访响应率.
- 病例类型的比较,包括自发报告 (SR),患者支持计划 (PSP) 和文献,跨越各种ICSR特征 (例如严重,列表,疑似) 和产品类别 (创新型,生物,仿制药,组合).
主要成果:
- 对不同类型的ICSR (SR,PSP,文献) 和病例分类 (严重/不严重,列出/未列出,可疑/不可疑) 的反应率的分析.
- 对创新,生物,仿制和组合产品的后续有效性的比较见解.
- 在欧洲经济区 (EEA) 疫情前的背景下,对后续行动的描述.
结论:
- 该研究提供了关于不同ICSR后续策略有效性的经验数据.
- 调查结果强调了随访成功的差异,这取决于报告来源和病例特征.
- 结果旨在为持有者和监管机构制定和采用更有针对性的,基于风险的ICSR后续流程提供信息.
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