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首页> 外文期刊>The regulatory affairs journal: Pharma >providing Good Quality Comment on Consultation DocumentsThe members of the Regulatory Intelligence Networking Group discuss their best practice guide for writing a value-added stakeholder commentary.
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providing Good Quality Comment on Consultation DocumentsThe members of the Regulatory Intelligence Networking Group discuss their best practice guide for writing a value-added stakeholder commentary.

机译:在咨询文件中提供高质量的评论监管情报网络小组的成员讨论了有关编写增值的利益相关者评论的最佳实践指南。

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摘要

One of the core responsibilities of a regulatory intelligence professional is to design and manage internal processes that ensure that draft guidance documents, regulations and legal provisions issued for public consultation are identified and get reviewed by relevant company experts1. Where appropriate, the commenting process must also ensure that a well-drafted company response is submitted in a timely manner to industry trade bodies and/or regulatory authorities.Based on our accumulated experience in generating concise and value-added stakeholder commentaries on consultation documents, as well as on internal impact assessments performed on the final published documents, we, the members of the Regulatory Intelligence Networking Group (RING), have developed the following "Golden Rules" to help document reviewers and comment co-ordinators provide good quality comments.Although RING is an EU-based organisation, we hope that our advice will be useful to all organisations that provide comments on consultation documents, regardless of where they are based or to which authority they are responding. We provide some basic rules, which companies may wish to amend and adapt to suit their own requirements.
机译:监管情报专业人员的核心职责之一是设计和管理内部流程,以确保标识出征求意见稿的指导文件,法规和法律规定并获得相关公司专家的审核1。在适当的情况下,评论过程还必须确保及时向行业贸易机构和/或监管机构提交经过精心草拟的公司回复。基于我们在针对咨询文件生成简洁,增值的利益相关者评论方面的累积经验,除了对最终发布的文件进行的内部影响评估之外,我们(监管情报网络小组(RING)的成员)还制定了以下“黄金规则”,以帮助文件审阅者和评论协调员提供高质量的评论。尽管RING是一家总部位于欧盟的组织,但我们希望我们的建议将对所有对咨询文件提供评论的组织有用,无论它们来自何处或响应于何种权威。我们提供了一些基本规则,公司可能希望对其进行修改和调整以适合其自身的要求。

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