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
Who Should Attend
Professionals working in:
Regulatory Affairs
Dossier Management
Document Management
Data Management
Compliance
Electronic Publishing/Submissions
IT/IS EDMS
Medical Writing
Regulatory Affairs Agency eSubmission processing and review
Learning Objectives
At the conclusion of this course, participants will be able to:
Participate in the preparation of the eCTD including “submission ready documents”
Recognise eCTD requirements on a regional and ICH basis
Discuss the processes and procedures of compiling and reviewing an eCTD
Create and submit technically valid GCC eCTDs
Prepare to move from a paper to eCTD process
Describe technology used for eCTD compilation, validation and review
Understand the difference between eCTD and NeeS submission
Have an overview on future eSubmission development
