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The countdown to China’s eCTD v1.1 implementation in 2026 has begun, and the changes are more than just technical - they will impact how regulatory submissions are planned, validated, and executed. If your organization is submitting in China – or is planning to do so - understanding these shifts early is critical to ensuring compliance and avoiding costly delays.

Our experts, Maren Müller and Michael Faust, know how to navigate complex compliance landscapes. Their years of hands-on experience allow them to pinpoint the most crucial elements for your regulatory strategy when submitting in China. These elements are essential for ensuring that your regulatory processes are not only resilient but also future-proof.

Date: Thursday, 26 February
Time: 16:00 – 17:00 CET / 10:00 – 11:00 EST
Participation is free of charge. 

Don't know if you can join live? Register now to receive the recording!


Join this session to find out more about:

    • Timelines & What’s Changing Now – We’ll outline the roadmap and explore what to consider for your regulatory strategy in China.
    • Regulatory Requirements & New Submission Scopes – Discover the changes in the submission scopes and how the update affects your applications.
    • Validation Criteria: What’s New, What’s Critical – Learn about updated validation rules, common pitfalls to avoid, and how to adapt your workflows.
    • Technical Upgrades “Behind the Scenes” – Have a look into what is happening on the technical side and get a deeper understanding of the underlying processes.
    • Key Takeaways and Live Q&A – Get a concise action list to prepare your organization now, and have your questions answered live by our experts.
    • Sneak Peek into EXTEDO's Submission Management Hub – See how the Submission Management Hub supports compliance, streamlines submissions, and reduces preparation time.

This is more than just an update briefing - it’s your opportunity to understand the real-world impact of China’s eCTD v1.1and to prepare your team for a smooth transition.

Your Speakers: 

Maren (1) Maren Müller
Senior Product Manager
Michael Faust (1) Michael Faust
RCC Business Consultant