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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
To successfully meet electronic Common Technical Document (eCTD) submission requirements, organizations must understand the underlying Common Technical Document (CTD) structure. In addition, participants will receive suggestions for implementing changes to support 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.
1/9/2023 – 2/21/2023: Early Bird $825.00 member | $970.00 nonmember 2/22/2023 – 3/22/2023: Regular $970.00 member | $1150.00 nonmember
At the conclusion of this workshop, participants should be able to:
The program is a boot camp for regulatory professionals who need basic knowledge of the CTD format.
This workshop is beneficial for professionals— particularly medical writers, regulatory operations professionals, and submissions-publishing specialists—working in the drugs, biologics, or combination products fields and involved in preparing electronic submissions. There are no prerequisites for participation.
Speakers:
Marianne MowrerRegulatory Operations consultant, Professional eSubmission Services, Inc
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 mor than 20 years’ experience preparing documents and regulatory submissions for the domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted more than 1,000 submissions to 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 creating documents from multiple authors and contributors, and generation of agency-compliant PDF files.
Nora KeelingQA/Regulatory Submissions Consultant, Professional eSubmission Services, Inc
Nora Keeling has more than eight years of regulatory operations and FDA submissions quality control experience, 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. Keeling is responsible for formatting quality control, ensuring documents meet regulatory specifications, as well as quality control-submission compilation.
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 raps@raps.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 raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.