{"title":"The New Written Summaries to Be Attached to the Expert Report — Concepts and Requirements","authors":"F. de Crémiers","doi":"10.1177/009286159603000310","DOIUrl":null,"url":null,"abstract":"This paper covers recent revisions to the European Notice to Applicants. The structure of the notice and new requirements are covered. Written summaries with tabular overviews should now be attached to expert reports for certain categories of products. These summaries provide a summary of the data and are used by regulators to prepare their assessment reports. They should facilitate the assessment task and speed up the application process.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"30 1","pages":"675 - 678"},"PeriodicalIF":0.0000,"publicationDate":"1996-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159603000310","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Information Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/009286159603000310","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
This paper covers recent revisions to the European Notice to Applicants. The structure of the notice and new requirements are covered. Written summaries with tabular overviews should now be attached to expert reports for certain categories of products. These summaries provide a summary of the data and are used by regulators to prepare their assessment reports. They should facilitate the assessment task and speed up the application process.
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