{"title":"Roads Leading to Approval: The Right Level of Detail for CMC Submissions","authors":"Sidonie Jones","doi":"10.55752/amwa.2024.344","DOIUrl":null,"url":null,"abstract":"Conference Education Session Report\nSpeakers\nHelen (Nellie) Forwood, MA, RAC, CQE, Associate Director Regulatory Writing, Certara, Rockland, DE\nCarlos Rousselin, BS, Associate Principal Regulatory Writer, Certara, Nashville, TN","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"5 11","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"AMWA Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.55752/amwa.2024.344","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
通往批准之路：提交 CMC 文件的正确详细程度
大会教育会议报告主讲人Helen (Nellie) Forwood, MA, RAC, CQE, Associate Director Regulatory Writing, Certara, Rockland, DECarlos Rousselin, BS, Associate Principal Regulatory Writer, Certara, Nashville, TN
本文章由计算机程序翻译，如有差异，请以英文原文为准。
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