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:
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.