关于欧洲动物试验替代方法伙伴关系 (EPAA) "新方法方法 (NAMs) 用户论坛启动研讨会"的报告
Mark T D Cronin1, Maria T Baltazar2, Tara S Barton-Maclaren3
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, United Kingdom.
Regulatory toxicology and pharmacology : RTP
|March 2, 2025
概括
欧洲动物试验替代方法伙伴关系 (EPAA) 用户论坛探讨了化学安全的新方法方法 (NAM). 为在下一代风险评估 (NGRA) 中监管使用NAM提出了建议.
科学领域:
- 毒理学和化学安全
- 监管科学 监管科学
- 在体外和in silico方法.
背景情况:
- 欧洲动物试验替代方法伙伴关系 (EPAA) 召开了一场关于新方法方法 (NAMs) 的研讨会.
- 重点是对化学安全评估的NAM的监管应用,特别是下一代风险评估 (NGRA) 中.
- 之前的EPAA皮肤敏感化用户论坛和欧洲委员会消费者安全科学委员会 (SCCS) 的调查结果为讨论提供了信息.
研究的目的:
- 为了了解NAM用于化学安全评估的监管使用情况.
- 收集有关NAM实施的利益相关者的学习和经验.
- 制定建议,以将NAM集成到NGRA中.
主要方法:
- 演讲总结了以前的EPAA皮肤敏感化用户论坛和SCCS.的学习经验.
- 来自五个案例研究的结论概述,说明NAM应用.
- 利益相关者之间的讨论,以收集关于NAM使用的见解.
主要成果:
- 在NGRA中确定了NAM的关键领域:暴露评估,危险识别,分层测试和使用NAM数据进行风险评估.
- 强调了NAM的实际实施,包括使用 -omics技术.
- 强调需要能力建设和培训,以有效利用NAM.
结论:
- 美国环保署用户论坛 (EPAA User Forum) 作为一个平台,与NAM分享安全评估人员的经验.
- 为NGRA框架内对NAM的监管应用制定了建议.
- 根据研讨会成果,建议未来的EPAA用户论坛格式和主题.
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