IF 3 4区 医学 Q1 MEDICINE, LEGAL
Mark T D Cronin, Maria T Baltazar, Tara S Barton-Maclaren, Ofelia Bercaru, K Nadira De Abrew, Christian Desaintes, Sylvia E Escher, Petra Kern, Gavin Maxwell, Vera Rogiers, Katrin Schutte, Tomasz Sobanski
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引用次数: 0

摘要

2023 年 12 月 7-8 日,欧洲动物试验替代方法合作伙伴关系(EPAA)在芬兰赫尔辛基的欧洲化学品管理局(ECHA)举办了 "新方法(NAMs)用户论坛启动研讨会"。用户论坛的目的是深入了解新方法方法在监管方面的应用,特别是下一代风险评估 (NGRA) 在化学品安全评估方面的应用。为实现这一目标,演讲总结了之前 EPAA 皮肤过敏用户论坛以及欧盟委员会消费者安全科学委员会 (SCCS) 的学习成果和经验。会议还总结了五个案例研究的结果,说明了非杀伤性物质的使用情况。通过发言和随后的讨论,汇集了所有利益相关方在使用营养物质管理方面的经验和见解。会议提出了在国家地质评估中规范使用国家记录和档案的建议,即暴露评估、危害识别、使用分级和有针对性的测试策略、使用国家记录和档案数据进行风险评估、国家记录和档案的实际实施、组学技术的使用以及能力建设和培训需求。EPAA 用户论坛为安全评估人员提供了一个交流学习和经验的开放平台。还就未来 EPAA 用户论坛的形式和主题提出了建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) "New Approach Methodologies (NAMs) User Forum Kick-off Workshop".

The European Partnership for Alternative Approaches to Animal Testing (EPAA) held the "New Approach Methodologies (NAMs) User Forum Kick-off Workshop", at the European Chemicals Agency (ECHA), Helsinki, Finland on 7-8 December 2023. The aim of the User Forum was to gain insight into the regulatory use of NAMs, with a particular reference to Next Generation Risk Assessment (NGRA), for chemical safety assessment. To achieve this, presentations summarised the learnings and experiences of previous EPAA Skin Sensitisation User Forums as well as that of the European Commission's Scientific Committee on Consumer Safety (SCCS). The findings of five case studies were summarised that illustrated the use of NAMs. The presentations and subsequent discussions allowed for learnings and insights to be compiled from all stakeholders with regard to the use of NAMs. Recommendations for the regulatory use of NAMs in NGRA were made namely for exposure assessment; hazard identification; using tiered and targeted testing strategies; performing risk assessment using NAM data; the practical implementation of NAMs; the use of -omics technologies; and the needs for capacity building and training. The EPAA User Forum provided an open platform for safety assessors to share learnings and experiences. Recommendations for the format and topics of future EPAA User Forums were also made.

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来源期刊
CiteScore
6.70
自引率
8.80%
发文量
147
审稿时长
58 days
期刊介绍: Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)
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