Intermediate Course for Regulatory Submissions in eCTD Format–October 2017

Thursday, October 19 - Friday, October 20, 2017

Registration closes at 11:59 pm Eastern, 10/16. If you need to register after this point, please email bbridges@raps.org.

Effective 5 May 2017 your company was required to migrate all NDAs, ANDAs and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To ensure you have successfully met these new requirements, you 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 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 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.