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The transition to eCTD v4 brings new technical and structural requirements that affect how submissions are prepared and published. It is not only about the new standard, but also how health authorities, e. g.  EMA and the US FDA, are approaching and realizing it in different ways. Regulatory teams working under tight pressure benefit from expert support when it comes to submitting in eCTD v4 to stay compliant and on time. 

In this webinar, our Regulatory Submission Publishing Services experts, Sylvie Colin and Ian Lake, point out some differences between eCTD v3 and eCTD v4, explaining why specialized publishing support is becoming essential. They will highlight the operational challenges eCTD v4 can create and show how dedicated eCTD v4 regulatory publishing services help ensure submissions stay compliant, on time, and stress-free for your team.


What you can expect:

- An overview of the key differences between eCTD 3.2.2 and v4
- Understand the operational pressures teams face during the transition
- See how dedicated eCTD v4 publishing services can reduce risk, ease workload, and support on-time submissions


Join this complimentary 30 minutes session and
 explore the possibilities to support your organization: 

Date: 05 March 2026
Time: 16:30 - 17:00 CET / 10:30 - 11:00 ET

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


Agenda:

- Brief introduction: eCTD 3.2.2 vs eCTD v4
- EMA eCTD v4 Publishing Service
- FDA eCTD v4 Publishing Service
- eCTD v4 Agency Submission Service

 

Whether you need expert guidance to overcome the challenges of your first eCTD v4 submissions in Europe or the US or a reliable long-term publishing partner to take over when your team's workload is too high, our Regulatory Submission Publishing Services have you covered. 

Attend this session to gain a better understanding of how eCTD v4 affects publishing workflows, and learn how partnering with experts can help your team manage complexity, stay compliant, and focus on the most important tasks. Secure your spot now!

 

Your Speakers:

Sylvie

Sylvie Colin
Senior Business Consultant and Publishing Services Lead  

Ian Lake

Ian Lake
Junior Business Consultant