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


Electronic Publishing/Submissions


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