Electronic Common Technical Document (eCTD) vendor workshop

• Date:
  Wednesday, 27 March 2024, 12:00 - 16:00 Coordinated Universal Time (UTC)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The electronic Common Technical Document (eCTD) is the standard norm for industry submissions for over 20 years and currently implemented by regulators and industry in version 3.2.2. Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting. 

This workshop, organised and facilitated by the eCTD v4.0 SME Group (EMA, NCAs and Industry), is intended for all eCTD Vendors that are interested in better understanding changes to the EU regional eCTD Specification. The event aims at fostering a discussion around the key sections of the new version of the Implementation Guide, the technical understanding of the implementation of the new standard, including the grouped submissions, document re-use and controlled vocabularies. At the moment, the focus will be on the Centralised Procedures only. 

Moreover, during the workshop, the scope and timeline of the pilot, as well as the timeline for the updates of the Implementation Guide, will be discussed. 

This session also offers an invaluable opportunity for participants to ask questions and provide feedback on pertinent matters.

Documents

Agenda - Electronic Common Technical Document (eCTD) vendor workshop

Registration

• Registration is open
  After registration you will receive a confirmation e-mail with the link and password to access the workshop. Please make sure to save those to be able to participate to the workshop.