Summary
With the next version of eCTD (Electronic Common Technical Document) now accepted or soon to be accepted by major health authorities for regulatory submissions, organizations must adapt their submission planning, processes, and documentation to be cohesive with this format. A key part of this will be understanding the differences between the new eCTD format (v4.0) and the eCTD version that has been widely used for many years (v3.2.2).
This webinar will offer an in-depth comparison of the eCTD 3.2.2 and eCTD 4.0 submission structure. Our experts will discuss the most significant changes and the distinctions that most directly impact submission preparation. Plus, they’ll provide practical guidance on navigating related challenges.
Whether you’re already planning submissions in eCTD 4.0 or getting ready for future possibilities, this webinar will provide the insights you need to stay on the forefront of regulatory submissions.
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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.
Product Owner
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