Introduction to Electronic Regulatory Submissions in the eCTD Format

Tuesday, February 21 - Wednesday, February 22, 2017

If you are new to preparing submissions documents for FDA, this is the introductory course that will begin your understanding of the steps you need to comply with the May 2017 electronic submission requirements.

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:

  • Different submission types
  • Which applications need to be submitted electronically
  • How to follow the eCTD structure
  • Agency-compliant PDF files and how to generate them
  • Which agency guidelines and technical specifications publishers need to follow
  • What is required to electronically submit your applications

We will also briefly discuss European, Canadian and US guidelines, and help you gain a basic understanding about each region.

Join us for this one-and-a-half-day training that will answer your eCTD questions and help you get on a direct path to compliance. 

Registration Dates

Registration Ends Monday, February 13, 2017