Building the eCTD - Practical Solutions to Compiling Electronic Submissions 2016

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