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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This workshop is currently sold out. If you would like to receive an email notification when this workshop is offered next, please complete the form at raps.realmagnet.land/ectd-october-2020-lead-gen.
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 need to comply with the impending electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . 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 underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:
Join us for this two-day, training that will answer your eCTD 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. There are no prerequisites for participation.
NOTE: Program content may vary.