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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual event. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Do you have a
working knowledge of the CTD structure and need to learn how to correctly apply
it to electronic submissions? Or do you need to know what is required to comply
with the FDA’s May 2020 guidances? If you already have a working
knowledge of the CTD structure and …
this course is for you.
Effective May 2020 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations 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 intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.
This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing.
NOTE: Program content may vary.
Substitutions may be accepted with written approval from RAPS and must be
submitted to email@example.com. Due
to uncertainty surrounding the COVID-19 situation, RAPS will allow
substitutions up to the first day of the event.