This course offers insight into the compilation of the eCTDs, experience and best practice gained during eCTD submissions and explains the eCTD review und lifecycle process. The course would be held on 12th and 13th December at Four Points Sheraton, Dubai.
Four Points by Sheraton, Khalid Bin Walid Street, Dubai
12 December 2016, 08:00 AM
13 December 2016, 05:40 PM
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.
On attending the course, 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