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Intermediate Course for Regulatory Submissions in eCTD Format - June 2019



Loyola University Chicago
Philip H. Corboy Law Center
25 East Pearson Street
Chicago, IL 60611

Workshop attendees will be accessing LORENZ' cloud environment to use LORENZ docuBridge in real time as they learn about eCTD concepts taught by Marianne Mowrer, Nora Keeling, Patrick Champoux, Parul Patel and Raj Kumar Thangavel.

Are you currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements? Here's what to do.

ffective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

- How to comply with the May 2018 electronic submissions requirements
- Which agency guidelines and technical specifications publishers need to follow
- How to apply ICH and regional requirements to your eCTD
- How to compile documents into the XML backbone of an eCTD, and lifecycle that application
- How to QC and validate an eCTD
- How metadata and study tagging files work
- Tips, tricks and best practices gathered from industry professionals
- How convert from a paper application to an eCTD
- How the new Module 1 (version 3.3) can be used for regulatory submissions
- What CTD readiness really means

We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW) and give you a basic understanding how the regions differ.

Join us for this two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.

For more information, please follow this link.

13 Jun 2019
14 Jun 2019
Chicago, Illinois, United States