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:
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.