Date: May 14, 2025
Time: 10 am ET/ 2 pm GMT
Solutions: Regulatory
Services: Regulatory Operations
Products: GlobalSubmit™
Summary
Major health authorities around the world are implementing or preparing to implement the next major version of eCTD for regulatory submissions. As the most consequential update to eCTD in the last two decades, it is essential for pharmaceutical and biotech companies to stay well-informed and poised to make this transition.
In this webinar, we will provide a comprehensive overview of when and how each region is adopting eCTD 4.0, including the latest updates from major regulatory bodies such as US FDA, EMA, Health Canada, and Japan’s PMDA. Additionally, we’ll share tips and strategies for making the shift to eCTD 4.0 seamless.
Join our live webinar as we explore the global rollout of eCTD 4.0 and how to successfully navigate this transition.
Key Learning Objectives:
- Understand the timing for eCTD 4.0 rollout globally
- How to plan for the transition to eCTD 4.0 submissions
- Implementation differences of major health authorities
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Associate Director, Regulatory Operations
Over 20 years of experience in eCTD submissions and FDA interactions.
Sr. Regulatory Services Manager
Rachel Bombara has more than 13 years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.
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