eCTD Training
Where
Mövenpick Grand Al Bustan – Dubai, UAE
When
23 April 2026
SEATS
Limited Seats Available
All participants are required to bring their laptops to fully engage in the hands-on eCTD training sessions and practical exercises.
eCTD Workshop
The workshop is designed as a full-day, interactive eCTD training session that engages both regulators and industry teams, ensuring aligned understanding of the electronic submission process.
This immersive workshop gives participants the opportunity to collaborate in groups, work through realistic eCTD submission scenarios, and apply best practices through guided role-play and practical exercises.
Using the EXTEDO suite, delegates will:
-
- Learn how to prepare, compile, and validate eCTD sequences
- Understand the expectations and needs of both regulators and industry teams
- Gain a shared perspective on the end-to-end eCTD submission lifecycle
- Strengthen their ability to manage compliant, accurate, and inspection-ready electronic dossiers
By the end of the workshop, participants will have a clearer, more unified understanding of the eCTD process and the standards required for successful submissions in the GCC region.
What is eCTD?
The electronic Common Technical Document (eCTD) is the global standard format for submitting regulatory information, such as: applications, variations, renewals, and reports, to health authorities. It provides a unified, electronic method for implementing the CTD structure, ensuring consistency and efficiency across all submissions.
An eCTD submission is composed of individual PDF documents organized in a structured, hierarchical format that mirrors the CTD modules. The submission is supported by an XML backbone, which links documents, defines metadata, and provides essential information required by regulatory reviewers.
The primary goal of adopting eCTD is to streamline the submission and review process, reduce administrative burden, improve document traceability, and enable faster, more efficient communication between applicants and regulatory authorities.
eCTD Workshop Agenda
| Time | Topic |
|---|---|
| 09:00 – 09:15 | Welcome |
| 09:15 – 10:00 | Introduction to eCTD |
| 10:00 – 11:00 | eCTD Basics and Regional Information, QC/ VAL, BP |
| 11:00 – 11:15 | Coffee Break |
| 11:15 – 12:45 | eCTD Role Play – Part 1 – Tool overview, QC and Basic Reviewing |
| 01:00 – 02:30 | Prayer & Lunch Break |
| 02:30 – 03:30 | eCTD Role Play – Part 2 – Managing Submissions and Advanced Review |
| 03:30 – 04:15 | Advanced eCTD – XML backbone and eCTD 4.0 |
| 04:15 – 04:30 | Q&A and Closing |
| 04:30 – 05:00 | (Optional, if required) |
Book Now
Early Bird pricing will apply until 15th February 2026.
All participants should bring their laptop in order to participate in the hands-on parts of the training.
