Webinar: Spot the Differences: Practical Nuances in EMA vs. US FDA eCTD v4

eCTD v4 is here – and it’s changing the way regulatory submissions are done around the world. If you are a regulatory professional, you already know how important it is to understand these changes and what they mean for your day-to-day work.

The core framework may be harmonized, but the reality is: EMA and US FDA each have their own way of implementing eCTD v4. And those differences aren’t just small details,  they can influence how you prepare, structure, and deliver your submissions.

Join us in this complimentary session and get practical, real-world insights that will make navigating eCTD v4 a lot easier - no matter which side of the Atlantic you’re on.

Date: 21 April 2026
Time: 16:00 CEST / 10:00 EDT
Duration: ca. 60 Minutes

Not sure if you can join live? Register to receive the recording!

In this live webinar, our expert Michael Faust will confidently walk you through:

• The big shift introduced with eCTD v4
• How EMA and US FDA requirements differ in practice
• A head-to-head comparison so you can spot the differences quickly
• What’s coming next and how to prepare for the future

Whether you’re getting ready for your first eCTD v4 submission or fine-tuning existing processes, this session will help you see clearly where the similarities end, where the differences begin, and how to work confidently with both agencies!

Your Speaker: 

Michael Faust RCC Business Consultant