Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
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 …
... then this course is for you.
Effective May 5, 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, and options available, 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 the Rest of the World (ROW) and give you a basic understanding how the regions differ.
Join us for this intense two-day, compilation demonstration and training that will answer your submission questions and help you get on a direct path to compliance and efficiency.
Objectives
At the conclusion of this program, participants will be able to:
Who Should Attend?
This intermediate-level course is for those with a working knowledge of the CTD format who are already preparing documents for FDA submissions. The program is a boot camp for regulatory professionals who need to comply with the May 5, 2020 FDA electronic submission deadline.
This workshop is beneficial for professionals working in the drug, biologic or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, technical writers, regulatory operations, regulatory affairs, and submission planners.
Agenda
NOTE: Program content may vary.
Speakers:
Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc. Marianne Mowrer, regulatory submissions specialist, Mentara Inc.
Registration from 26 February to 25 March 2020
RAPS Members: $1,000 Nonmembers: $1,100
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.
If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.
Other Information
Cancellation
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.
Program Contact
Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291