Building the eCTD - Practical Solutions to Compiling Electronic Submissions 2016
カンファレンス > Communications カンファレンス > Building the eCTD - Practical Solutions to Compiling Electronic Submissions
December 12 - 13, 2016
ドバイ , アラブ首長国連邦
This course will offer insight into the compilation of the eCTDs, share experience and best practice gained during eCTD submissions and explain the eCTD review und lifecycle process. Especially eCTD submissions in the GCC region will be addressed in detail. What you will learn - Overview of eCTD readiness at the agencies - Impact of the eCTD on regulatory processes and procedures - Practical experience of submitting an eCTD in the EU and GCC - eCTD compilation and life cycle management Document granularity and readiness Regulatory strategy facing technical issues Specifications and standards versus regions and procedures
主催者
DIA EMEA
+41612255151
関連イベント
Building the eCTD - Practical Solutions to Compiling Electronic Submissions December 12 - 13, 2016
Building the eCTD January 16 - 17, 2014