Join EXTEDO and Asphalion for a focused webinar presented by TOPRA. Together, we will help you get ahead on the move to eCTD v4 and build the knowledge foundation to address the next generation of structured regulatory submissions.

This session explores the essential concepts, regional expectations, and practical differences from v3.2.2 to eCTD v4, and closes with a short live demo showing how an eCTD v4 package looks in a viewer.

Date: 28 October
Time: 14:00–15:00 GMT / 15:00–16:00 CET

Note: The webinar is free of charge for all TOPRA members, as well as for non-members.


Topics Include:

  • Core terminology and mechanics behind eCTD v4 and why they matter for publishers
  • Regional specifics and implementation differences across EU, US, CA, CH, and AU — where alignment helps and where you must adapt.
  • A practical comparison of v3.2.2 vs v4.0: improved data structure, lifecycle management, and metadata that streamline submissions.
  • Short live demo: see an eCTD v4 package in a viewer to link concepts to the real user experience.

Learning Outcomes

  • Understanding of eCTD v4 terminology and concepts
  • Overview of regional requirements for eCTD v4
  • Insight into key changes from v3.2.2 to eCTD v4 and how they affect your publishing workflows

Reserve your spot to learn about the language, the regional context, and a practical perspective on eCTD v4 – register now!

Your Speakers:

Maren

Maren Müller
Product Manager
Daniel Langa, ASPHALION

Daniel Langa García
Regulatory Affairs Associate Director | European Medicines Agency SME

 




Register Now