Regulatory Submissions in eCTD Format: A Hands-On Approach

If you are currently preparing CTD submissions for the FDA submissions and are familar with the CTD structure, but need to learn how to comply with the May 2017 electronic submission requirements, this course is for you.

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:

• Which types of applications need to be submitted electronically
• How to comply with the May 2017 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 lifecyclethat application
• How to QC and validate an eCTD
• How metadata and study tagging files work
• Tips, tricks and best practices gathered from industry professionals
• Converting from a paper application to an eCTD
• What CTD readiness really means

We will also provide an overview of the difference submissions to US and Rest of the World (ROW), and help you understand how to prepare for each region.

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