Introduction to Regulatory Submissions in the eCTD Format - June 2022

12.0
RAC Credits
Virtual Programs Virtual Programs
Thursday, 23 June 2022 (10:00 AM) - Friday, 24 June 2022 (5:00 PM) Eastern Time (US & Canada)

To successfully meet electronic Common Technical Document (eCTD) submission requirements, organizations need to understand the underlying Common Technical Document (CTD) structure upon which electronic submissions are built. In addition, participants will get suggestions for implementing operational changes to support successful electronic regulatory applications. During this workshop, you will learn:

  • Different submission types
  • Which applications need to be submitted electronically
  • How to understand and follow the CTD structure
  • How to use the M4 series of guidances and granularity to generate compliant submissions
  • Agency-compliant PDF files, and how to generate them
  • Which agency guidelines and technical specifications publishers need to follow
  • What tools are required to submit your applications electronically

* Please see the cancellation policy below.

Learning Objectives

After this program, participants will be able to:

  • Understand the acronyms and terms relevant to electronic submissions
  • Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD
  • Identify best practices with software used to generate electronic submission content
  • Produce MS Word and PDF documents that meet FDA guidelines
  • Obtain a basic understanding of what is required to transition to submitting in the eCTD format

Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance.


Pricing/Deadlines

17 Jan 2022 – 24 May 2022: $825 Members | $970 Nonmembers

25 May 2022 – 23 Jun 2022: $970 Members | $1,150 Nonmembers


Who Should Attend

The program is a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions.

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 professionals, and submissions publishing specialists. There are no prerequisites for participation.


Agenda

  • Define important terminology used in e-submissions
  •  Provide a detailed breakdown of the CTD structure
  • Understand the M4 series of guidance (ICH) and FDA technical specifications
  • Learn how to create FDA-compliant MS Word documents
  • Learn how to create FDA-compliant PDF documents from differing sources
  • Review the workflow process using planners to produce an eCTD
  • Learn how to convert from a paper application to an eCTD application
  • Learn the basics of managing an electronic submissions project
  • Review the entire lifecycle of an electronic submission from first steps to eCTD
  • Learn tips, tricks, and best practices
  • What does eCTD readiness mean?


NOTE: Program content may vary.


Speaker(s):

Marianne Mowrer

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

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.

 

Cancellation Policy

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.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

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  

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