CDE:注射剂一致性评价研讨会视频与PPT资料!
发布日期:2020年08月25日浏览数:2452
8月11日,国家药监局药审中心向行业公开:化学仿制药注射剂一致性评价技术研讨会视频与PPT资料。
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为落实扶贫政治任务,加强与业界沟通交流,加快推进化学仿制药注射剂一致性评价工作,由中国药品监督管理研究会主办,国家药品监督管理局药品审评中心提供技术指导的“化学仿制药注射剂一致性评价技术研讨会”于2020年7月15至17日在线上举办。研讨会内容以化学仿制药注射剂一致性评价相关专题为主,同时兼顾新修订《药品注册管理办法》及配套文件的讲解,系统介绍了化学仿制药注射剂一致性评价的工作概况、技术要求、指导原则、启动检查检验、参比制剂遴选、包材相容性、杂质研究、原辅料关联审评等内容,并就相关问题进行了线上交流研讨。经整理,现将会议视频和PPT资料在网站发布,供观看。http://www.cncsdr.org/ggtz/zxtz/202008/t20200807_55554.html
2020年8月11日
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另有以下附件,因图片较多,请扫码或点击文末“阅读原文”查看
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