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Intermediate Course for Regulatory Submissions in eCTD Format - July 2018



LORENZ has again been selected as RAPS's vendor of choice to support their eCTD workshops. Workshop attendees will be accessing LORENZ's cloud environment to use LORENZ docuBridge in real time as they learn about eCTD concepts taught by Marianne Mowrer and Elsmari Eggers.

US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, Maryland, USA, 20852-1717

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.

Effective 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. The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the processes needed 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 to 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.

26 Jul 2018
27 Jul 2018
Rockville, United States