The Disruption Series: MedDRA Now Impacted By Coronavirus

混乱系列:MedDRA现在受到冠状病毒的影响

2020-05-16 01:50 lionbridge

本文共396个字,阅读需4分钟

阅读模式 切换至中文

This is the ninth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.   Coronavirus now has such influence that multinational bodies are changing their reporting systems to create standardized MedDRA terms. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced on April 1 the availability of new MedDRA terms on the MSSO’s website for coding and reporting related to coronavirus. The MedDRA (Medical Dictionary for Regulatory Activities) offers a single standardized and internationally harmonized medical terminology. Researchers, healthcare workers and governments use it for regulatory communication and data evaluation on human medicinal drugs. The official planned release of the next MedDRA, Version 23.1, is in September 2020. MedDRA terminology is applicable throughout the life cycle of a medicinal product. This includes during clinical trials, regulatory drug registration and safety monitoring in post-marketing phase. At the time of the ICH announcement, corona-related terms were available in English only but will be made available in all languages shortly. The current languages in the scope of the medical dictionary include Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Brazilian Portuguese, Russian and Spanish. Having a multilingual medical terminology database facilitates accurate data sharing across regulatory territories and analysis of medical events using a hierarchical structure. As a language service provider, the adoption of MedDRA terminology into the language technology stack is immediate for Lionbridge. We are dedicated to supporting clients in obtaining consistent and accurate terminology across all languages and phases of the drug life cycle. Use of MedDRA standards for regulated content related to human medicines enables not only optimization of communication and regulatory processes. It also facilitates easy international exchange of data; cross references and analysis without distortion of data. In the case of a pandemic, international exchange of knowledge is key to reducing the impact of a disease around the world. Lionbridge can apply MedDRA terminology to all regulated content throughout the life cycle of your medicinal products. This includes translations related to multinational clinical trials, drug dossier submissions under M4 CTD standards and safety reporting. Our Lionbridge Life Sciences team is working around the clock to help our customers minimize business impact of the pandemic—and to stop the pandemic itself. Reach out to see how we can help.
这是莱博智(Lionbridge)系列的第九篇文章,该系列是生命科学专家关于新冠病毒危机导致该行业如何发生变化的评论集。 冠状病毒现在的影响力如此之大,以至于多国机构正在改变他们的报告系统,以此创建标准化的MedDRA术语。国际协调人类用药物技术要求理事会(ICH)于4月1日宣布,MSSO网站上提供了新的MedDRA术语,用于与冠状病毒相关的编码和报告。 MedDRA(管理活动医学词典)提供了一个单一的,标准化的和国际统一的医学术语。 研究人员,卫生保健工作者和政府利用它进行管理交流和人类药物的数据评估。 官方计划在2020年9月发布版本23.1的新一款MedDRA。 MedDRA术语适用于医药产品的整个生命周期。 这包括临床试验期间,监管药物注册和上市后阶段的安全性监测。 在ICH宣布时,Corona相关术语仅有英文版本,但不久将提供所有语言版本。 目前医学词典范围内的语言包括汉语,捷克语,荷兰语,法语,德语,匈牙利语,意大利语,日语,韩语,葡萄牙语,巴西葡萄牙语,俄语和西班牙语。 拥有一个多语言医学术语数据库有助于跨监管地区的准确数据共享和使用层次结构分析医学事件。 作为一家语言服务提供商,将MedDRA术语采用到语言技术栈中对Lionbridge来说是立竿见影的。 我们致力于为客户提供跨语言和药物生命周期各个阶段的一致和准确的术语支持。 使用MedDRA标准来管理与人类药品有关的内容,不仅能够优化沟通和管理流程,它还便利了数据的国际交换; 不失真数据的交叉引用和分析。 疫情面前,国际知识交流是减少疾病在世界各地影响的关键。 莱博智可以将MedDRA术语应用于医药产品整个生命周期中所有规定内容。 这包括与多国临床试验相关的翻译,M4 CTD标准下的药物档案提交和安全性报告。 我们的莱博智生命科学团队正夜以继日地工作,帮助我们的客户将疫情对业务的影响降至最低,并阻止疫情继续发展。 来看看我们能帮什么忙。

以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。

阅读原文