Regulatory Submissions in eCTD Format: A Hands-On Approach

Thursday, February 23 - Friday, February 24, 2017

If you are currently preparing documents for FDA submissions and familiar with the process, 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
  • What agency-compliant PDF files are
  • Which agency guidelines publishers need to follow
  • How metadata and study tagging files work
  • How to compile documents into the XML backbone of an eCTD
  • What is required to electronically submit your applications

We will also provide more detailed information on the European, Canadian, and US guidelines, and help you understand how to prepare for each region.

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.

Registration Dates

Registration Ends Wednesday, February 15, 2017