Complimentary Webinar: DMF Submissions for US and EU

From May 5, 2017, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be submitted in eCTD format. For ASMF submissions in Europe, the eCTD standard is already mandatory. 

EXTEDO would like to invite you to join its complimentary webinar "DMF Submissions for US and EU". 

Agenda
  • EXTEDO company overview
  • Timelines
  • Types of US DMF and EU ASMF
  • DMF/ASMF and eCTD
  • Switch from paper to eCTD
  • Live demo of example DMF/ASMF eCTD creation
  • Q&A session
Event Details
  • Date: Friday, 24 February 2017
  • Time: 02:00 pm CST (Shanghai, Beijing)
  • Duration: 60 minutes
  • Participation is free of charge

免费的网络研讨会: 美国和欧盟的DMF提交

 

从2017年5月5日起,所有提交给美国药监局的新型药品DMF以及所有关于已有药品DMF的额外补充提交,都必须采用eCTD格式。目前欧洲境内的的ASMF提交都已经强制使用了eCTD标准格式。

因此,EXTEDO 诚挚地邀请您参加免费的网络研讨会 ,研讨会主题为:“美国和欧盟的DMF提交”。

流程:
  • EXTEDO公司概况
  • 时间轴
  • 美国DMF和欧盟ASMF的种类
  • DMF/ASMF和eCTD格式
  • 从纸质材料到 eCTD的改变
  • 创建eCTD DMF/ASMF的在线演示
  • 问答环节
活动细节
  • 日期:周五,2017年2月24日
  • 时间:14:00(上海,北京)
  • 时长:60分钟

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