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Overview

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

From 31st December 2020, new marketing authorization applications for medicinal products to the Economic Area of Eurasia (EAEU) need to follow the electronic EAEU submission format. In addition, follow-up submissions must be compliant before 31st December 2025.

Therefore, pharmaceutical companies should start converting their existing approved EAEU applications into this new electronic format. Moreover, applications that do not yet have an existing approved EAEU application should now start their application directly in this new electronic format.

For these actions to occur it is essential to have a clear understanding of what the new electronic EAEU submission format entails. This session provides a general overview as well as highlight the key guidelines which underpin this new formatting structure. It will address the differences and similarities between the electronic EAEU format in comparison to the ICH eCTD format. Furthermore, it will look into the different validation options available as well as specifically address some of the key factors that must be taken into account to ensure a technically valid EAEU submission.

Throughout the session, I will also refer to my real-time experiences as Project Manager for various submission publishing projects highlighting some of the best practices that are recommended during a submission publishing project detailing how to go from electronic PDF documents to a valid eCTD submission.

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Describe the general structure of an electronic EAEU submission
  • Write the differences and similarities between the EAEU electronic submission format and the ICH eCTD format
  • Outline aspects that are needed in order to publish technically compliant electronic EAEU submission

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