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:
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.