Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description: eCTD 4.0 is the major milestone in the evolving world of eSubmissions. But while publishers might understand the technical changes, the reality of working on an eCTD 4.0 sequence is proving challenging for many publishers.
From context of use to group titles to keywords, it has been assumed that eCTD 4.0 is just eCTD 3.2 with some new lifecycle operations. We will discuss how even the most experienced publishers are struggling to understand this new format, drawing on our experience working with clients to pilot in all three regions where eCTD 4.0 is in use – the US, Japan and EMA. With mandatory dates in 2026 your organization must prepare now – or risk running out of time.
Piloting is a powerful way to prepare for eCTD 4.0 implementation, without the risks of waiting until it's mandatory. Participating in a pilot can be dauting; this session will also highlight how organizations can plan, prepare, and execute effective piloting strategies to ensure all systems are go, when eCTD 4.0 becomes mandatory.
We’ll present real world case studies and discuss: • The experiences of real publishers creating eCTD 4.0 submissions • What to look out for when publishing eCTD 4.0 • How to best prepare your organisation • The key benefits and risks of a pilot for your organization • How to use pilots to prepare for eCTD 4.0 while minimizing time pressure on staff • How to assess pilot outcomes and identify action items • How to establish productive technical partnerships to support your organization from technical pilot to live submission
Learning Objectives:
Upon completion, participants will understand the experiences of publishers using the latest iteration of eCTD.
Upon completion, the participants can describe the practical differences of working on a eCTD 4.0 sequence.
Upon completion, participants will know how to prepare internally to ensure you are ready for eCTD 4.0 and understand the benefits of participation in pilots.
