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The Toxicology Forum 40th Annual Summer Meeting

The Toxicology Forum 40th Annual Summer Meeting
毒理学论坛第 40 届夏季年会
批准号:
8839077
负责人:
JAMES E KLAUNIG
金额:
$1.5万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-09-05 至 2015-08-31

项目摘要

项目成果

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中文摘要
翻译
项目摘要摘要 毒理学论坛为推进美国FDA的监管科学议程提供了一个独特的场所 从而改善公共健康。毒理学论坛在不同国家之间进行透明对话 关注毒物学问题的社会阶层。每一次科学会议都代表着一个谨慎的 对指定的主题采取平衡的方法,为每个主题呈现一个问题的所有方面。唯一的,非- 毒理学论坛会议的敌对气氛导致了不需要的坦率和开放的讨论 达成共识,但促进对这一问题的共同理解。每一次科学会议 毒理学论坛提供了一个机会,以发展对最新科学数据的共同理解, 对数据的解释和调查结果的政策影响。 过去15年的项目强调新的科学工具(基因组学、蛋白质组学、代谢组学) 以及这些工具如何能够更好地决定受美国FDA监管的产品的安全性。已经有了 更加强调在人类相关性方面挑战传统的生物检测方法,并讨论 产品安全评估的替代分析一直是多次讨论的主题,该组织已经 有助于形成对这种毒理学和其他临床前毒理学的正确解释的共同理解 学习。这些计划支持美国FDA监管科学战略计划中概述的目标 促进公共卫生。 美国FDA毒理学论坛的相关内容近年来已扩大和正规化 包括增加领导年轻学术科学家参与论坛讨论的机会 通过为年轻学术人员提供的旅行奖学金。另一个重要的变化开始于20世纪90年代末, 在欧盟所在地布鲁塞尔设立欧洲年度会议。这是国际的 SCOPE支持美国FDA的全球化努力,以加强国家监管系统。而具体的 问题和监管机制可能会因涉及的大陆和国家而有所不同,毒理学 论坛会议仍然是与政府探讨和讨论问题的有效和富有成效的方式, 工业界、学术界和消费者群体。
英文摘要
Project Summary Abstract The Toxicology Forum provides a unique venue for advancing US FDA's regulatory science agenda and thereby improving public health. The Toxicology Forum conducts transparent dialogues among various segments of society concerned with problems in toxicology. Each scientific session represents a carefully balanced approach to the designated topic with all sides of an issue presented for each topic. The unique, non- adversarial atmosphere of Toxicology Forum meetings results in frank and open discussions that do not need to arrive at consensus but foster a common understanding of the issue. Each scientific session of the Toxicology Forum provides an opportunity to develop a common understanding of the latest scientific data, the interpretation of the data and the policy implications of the findings. Programs in the past 15 years have emphasized new scientific tools (genomics, proteomics, metabolomics) and how these tools allow better decisions on safety of products regulated by the US FDA. There has been increased emphasis on challenging the traditional bioassays in terms of human relevance and discussion of alternative assays for product safety assessments have been the subject of multiple discussions which has help to develop a common understanding of the proper interpretation of this and other preclinical toxicology studies. These programs support the goals outlined in US FDA's Strategic plan for Regulatory Science and the advancement of public health. US FDA relevant elements of the Toxicology Forum that have been expanded and formalized in recent years include increasing opportunities for leading younger academic scientists to participate in Forum discussions through Travel Fellowships for young academic faculty. Another important change began in the late 1990s with the establishment of annual European meetings in Brussels, the seat of the European Union. This international scope supports US FDA's globalization efforts to strengthen national regulatory systems. While the specific issues and regulatory mechanisms may vary depending on the continent and country involved, the Toxicology Forum meetings continues to be a valid and productive way to explore and discuss issues with government, industry, academia, and consumer groups.
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