Agenda of the eCTD 4.0 Vendor Workshop (March 2024)

The electronic Common Technical Document (eCTD) has been the industry standard for submissions for over two decades. While version 3.2.2 is currently in use, version 4.0 was published in December 2015 and its latest Implementation Package was endorsed in May 2022.

The eCTD v4.0 SME Group (EMA, NCAs and Industry) is organizing this event to help vendors understand the key changes in the latest version of the Implementation Guide. The workshop will focus on the technical aspects of implementing the new standard, including grouped submissions, document reuse, and controlled vocabularies. Currently, the focus is on Centralized Procedures only.

The workshop organized on March 27th will cover:

• Key sections of the new Implementation Guide
• Technical aspects of implementing the new standard, including grouped submissions, document reuse, and controlled vocabularies
• Scope and timeline of the pilot program
• Updates to the Implementation Guide

This session provides a valuable opportunity for vendors gain a comprehensive understanding of the changes in eCTD v4.0 for the EU region, learn about the technical implementation of the new standard, and have your questions answered and provide feedback to the eCTD v4.0 SME Group.

For more information about the eCTD 4.0 vendor workshop, click here: https://www.ema.europa.eu/en/documents/agenda/agenda-electronic-common-technical-document-ectd-vendor-workshop_en.pdf

Find out more eCTD 4.0 related topics here:

• eCTD: Global Aspects and Future Directions

• eCTD 4.0: What is Changing?

• eCTD 4.0: Key Changes & Impact on Submission Content Preparation