Where
Movenpick Grand Al Bustan – Dubai, UAE
When
23 April 2026
SEATS
Limited Seats
All participants should bring their laptop in order to participate
eCTD Workshop
A full day focused on eCTD Training, that will bring together the two groups of players in Pharma: “Authority” and “Industry”
You have an opportunity to work together in groups on training submissions along with a typical eCTD scenario, learning through role-play and practical application.
Delegates will learn and discuss the needs of their counterparts and achieve a common understanding of the eCTD process, using the EXTEDO suite.
What is eCTD?
eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities.
It provides a harmonized solution to implement the Common Technical Document (CTD) electronically.
An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure. It also has an XML backbone which cross-links required documents and provides information regarding the submission.
The purpose of introducing eCTD is to reduce the burden on the reviewers and to simplify the process of submission to 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.
