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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 …
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:
How to comply with the May 2020 electronic submissions requirements
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.
At the conclusion of this program, participants will be able to:
1 January – 14 September 2021: Early Bird $800.00 Members | $900 Nonmembers
15 September – 7 October 2021: Regular $900.00 Members | $1,000 Nonmembers
This intermediate-level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 2020 FDA electronic submission deadline.
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.
Marianne Mowrer is a Regulatory Operations consultant working with her own group, Professional eSubmission Services, Inc., as well as Mentara, Inc., and other consulting groups. She has 20+ years’ experience preparing documentation and regulatory submissions for domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted over 1,000 submissions to multiple Regulatory Agencies, all without a single refuse-to-file. Her group enjoys an exceptional record of meeting critical deadlines, and for streamlining and managing the complex process of document creation from multiple authors and contributors, and generation of Agency-compliant PDF files for submission.
Nora Keeling has over eight years of experience in regulatory operations and FDA submissions Quality Control (QC), including hands-on experience with numerous CTD and eCTD submissions. She works as an independent consultant with her own team, Professional eSubmission Services Inc., as well as part of the Mentara, Inc. consortium. She has participated in the successful project management, document processing, compilation and submission of numerous eCTD sequences. Nora is responsible for formatting QC, ensuring documents meet regulatory specifications, as well as submission compilation QC.
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 to firstname.lastname@example.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.