The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.
Below we’ve compiled all our eCTD 4.0 webinars from 2024. Sign-up today to get access to these great and informative resources.
eCTD 4.0: New Standard, New Technology, New Opportunities
Our experts, Maryanne Loscalzo, Associate Director of Reg Ops, and Trevor Standish, Director of Product Management, provide an overview of eCTD v4.0.
During this webinar, they cover the similarities and differences between the FDA’s eCTD v4.0 and previous versions, as well as the FDA’s current plans for rolling out this new standard. A brief demo of GlobalSubmit Publish will help show exactly how eCTD v4.0 will appear when preparing a submission using this new standard.
eCTD 4.0: Exploring the Submission Structure
eCTD v4.0 establishes the use of keywords in the metadata as well as introduces the new harmonized submissionunit.xml. Together with modifications to the eCTD granularity, these changes present the familiar eCTD modules in a whole new way.
Watch as we explore the evolution of the submission structure and discover the importance of savvy software in navigating this new standard.
Answers to the top eCTD v4.0 questions in 2024
The rollout of eCTD v4.0 is accelerating. Timing for this industry-wide transition is no longer in the distant future but rather now. One health authority is already live, one is going live this year (2024), and multiple are planning to implement within the next year.
Certara has hosted webinars on eCTD v4.0, held GlobalSubmit user workshops, and collaborated with health authorities on their technical pilots in order to keep you abreast of the latest updates. With questions on eCTD v4.0 pouring in, we have compiled the most burning questions for 2024. Join us as we reveal these top questions and provide answers.