This two-day deep dive into eCTD compilation strategy, expert speakers will answer your submission questions and help you get on a direct path to compliance.
To successfully comply with eCTD requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.
Whether you use eCTD publishing software, plan/manage/author the content that goes into an eCTD submission, or have the responsibility to review/approve an eCTD sequence created by someone else prior to submission to a regulatory authority — learn from over 30 years of real-world knowledge and experience.
During this workshop, you will learn:
- How to apply electronic submissions requirements, and
- Which agency guidelines and technical specifications submissions must be adhered to
- How to recognize which ICH and regional requirements apply to your specific needs
- What publishing strategies can be used to compile documents into the XML backbone of an eCTD, to more successfully lifecycle that application
- Different strategic approaches for the organization and structure of your eCTD application
- How to QC and validate an eCTD sequence
- How metadata and study tagging files work and don’t work
- Tips, tricks and best practices gathered from industry professionals with over 30 years of hands-on experience across 100+ clients—we have truly seen the best, and worst, the industry has to offer
- How to identify regulatory activities and correctly apply submission type and submission subtype for Module 1 (version 3.3)
- What eCTD readiness really can mean—without spending tens-of-thousands of dollars
It’s one thing to learn to use eCTD publishing software. It’s another to make the rules of publishing work in your favor to fit your project.
If you are planning an electronic submission and already have a working knowledge of the CTD structure, this course will help you level up your knowledge.
Registration Fees & Deadlines
Present – 09 February 2026: Early Bird Member $865 | Nonmember $1,020
10 February 2026 – 09 March 2026: Regular Member $1,020 | Nonmember $1,200
Learning Objectives
At the conclusion of this workshop, participants should be able to:
- Identify best practices with software used to generate electronic submission content
- How to apply different submission strategies to fit your product
- Understand, and use, the acronyms and terms surrounding eCTD and electronic submissions
- Apply ICH and regional requirements for the content of an eCTD submission
- Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
- Obtain an understanding of what is really required to submit in the eCTD format
Who Should Attend?
This intermediate level course is for people who have a working knowledge of the CTD structure and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to brush up on the most current guidelines and specifications, or if you are someone who needs to better understand the organization and inner workings of an eCTD submission for authoring, planning, publishing, or reviewing/approving. You will learn strategies that have been successfully submitted to Regulatory Authorities.
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, technical writers, regulatory operations, regulatory affairs, and submission planners and publishers.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
Day 1
| Time |
Topic
|
|
9:00 - 9:10 AM
|
Introduction
|
|
9:10 – 9:30 AM
|
Pre-Submission History and Context
|
|
9:30 – 10:00 AM
|
Making Pre-Sub Decisions
|
|
10:00 – 10:30 AM
|
What Makes a Good Pre-Sub
|
|
10:30 – 11:00 AM
|
The Art of Pre-Sub Communications
|
|
11:00 – 11:15 AM
|
15 Minutes Break |
|
11:15 – 11:45 AM
|
FDA Perspective
|
|
11:45 AM – 12:00 PM
|
Case Study Presentation
|
|
12:00 – 12:30 PM
|
Pre-Submission Decisions Mock Scenarios – all |
|
12:30 – 12:45 PM
|
Best Practices – all |
|
12:45 – 1:00 PM
|
Final Q&A / Workshop Close |
Day 2
| Time |
Topic
|
|
9:00
|
Module 5: Clinical Study Reports (CSRs), Legacy vs. Granulated
|
|
9:20
|
Compilation: Module 5: Clinical Study Reports, datasets and case report forms (CRFs)
|
|
10:00
|
Compilation:
Module 2: Summaries; remaining clinical sections
|
|
10:40
|
Coffee Break
|
|
10:50
|
Electronic Submission Gateway (ESG)
|
|
11:15
|
US Module 1: Administrative Information
|
|
12:00
|
Lunch
|
|
12:45
|
eCTD Validation
|
|
1:30
|
Coffee Break
|
|
1:40
|
Compilation:
Module 1: Administrative Information
|
|
2:00
|
Publish and Validate the submission
|
|
2:10
|
Coffee Break
|
|
2:20
|
Validation Report Review
|
|
3:00
|
Lifecycling of Applications (Compilation)
|
|
3:25
|
eCTD Readiness – what it really means
|
|
3:40
|
Wrap-up and final questions
|
|
4:00
|
End of Day 2
|
Speakers
Marianne Mowrer
Regulatory Operations consultant, Professional eSubmission Services, Inc
Marianne Mowrer has been a regulatory operations professional since 2001. She has more than 20 years of 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 streamlining and managing the complex process of creating documents from multiple authors and contributors, and generation of agency-compliant PDF files.
Nora Keeling
QA/Regulatory Submissions Consultant, Professional eSubmission Services, Inc
Nora Keeling has more than 10 years of regulatory operations and FDA submissions quality control experience, including hands-on experience with numerous eCTD submissions. She works as a senior manager of global regulatory operations for Novavax as well as an independent consultant. She has participated in successful project management, document processing, compilation, and submission of eCTD sequences. Nora is responsible for quality control of document formatting and submission compilation as well as ensuring documents meet regulatory specifications.
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
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.