临床数据出版(政策0070)重新启动

Q2 Health Professions

Medical Writing Pub Date : 2023-09-22 DOI:10.56012/nnwx9514

Alison McIntosh

{"title":"临床数据出版(政策0070)重新启动","authors":"Alison McIntosh","doi":"10.56012/nnwx9514","DOIUrl":null,"url":null,"abstract":"In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.","PeriodicalId":37384,"journal":{"name":"Medical Writing","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Data Publication (Policy 0070) relaunch\",\"authors\":\"Alison McIntosh\",\"doi\":\"10.56012/nnwx9514\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.\",\"PeriodicalId\":37384,\"journal\":{\"name\":\"Medical Writing\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical Writing\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.56012/nnwx9514\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Health Professions\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medical Writing","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.56012/nnwx9514","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Health Professions","Score":null,"Total":0}

引用次数: 0

摘要

为了准备重新启动EMA临床数据出版物(Policy 0070)，于2023年5月16日举行了一次网络研讨会，会议的视频记录可以在线观看(https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar)。EMA政策0070重新启动适用于2023年9月起的新原料药，包括负面和撤回的产品。如果您的产品在范围内，我们将向您发送邀请函。值得注意的是，COVID-19和其他突发公共卫生事件的临床数据仍在继续发布。EMA已确认可以提供特定于产品的提交前会议，并鼓励申办者利用此类会议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Clinical Data Publication (Policy 0070) relaunch

In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.