The goal of any submission to a global health authority such as FDA or EMA is to provide information in a clear and organized format that will facilitate review and enable regulators to better understand the content of your submission and approve your product.
At this interactive workshop participants will learn how to provide structure and content to Module 3 that will facilitate review and avoid frustrating reviewers.
Recommendations will be given for creating data tables that are easy to understand and draw conclusions from, figures that are clean and clearly labelled, and wording that is uncomplicated and easy to read. Common submission mistakes and how to avoid them will be discussed. Avoiding requests for information that can delay approval will be discussed. In group breakouts redacted samples from actual submissions will be provided for analysis and discussion.
While this workshop will focus mainly on Module 3 and large molecules all the principles learned can be extrapolated to other modules and other technologies.
Registration Fees & Deadlines
Present – 25 February 2026: Member $440| Nonmember $520
26 February 2026 to 26 March 2026: Member $520 | Nonmember $610
Learning Objectives
Upon completion, participants will be able to:
- Organize text and tables across modules so content flows logically and is easy for reviewers to navigate.
- Apply effective wording strategies to avoid misunderstandings and unintended commitments.
- Identify common submission mistakes and implement best practices to make submissions more reviewer-friendly, improving overall outcomes.
- Determine where specific information belongs within Module 3 for accurate and compliant placement.
Who Should Attend?
- Regulatory professionals and technical writers who want to improve their technical writing skills
- Anyone new to technical writing for industry (any CTD module or other technical document) or to preparing a Module 3 for submission
- Personnel responsible for internal review of submissions
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
Morning Session
- Initial Breakout Session (All Participants) – 15 minutes
Why this topic?
- Review of Module 3 Basics
Structure and organization overview
- Module 3 by Clinical Phase Requirements – Part 1
- The Process Flow Diagram
- Break – 15 minutes
Mid-Morning
- Module 3 by Clinical Phase Requirements – Part 2
- Comparability Reporting in S.2.6
- Breakout #2 (Two Groups) – 20 minutes
Phase-appropriate submission structure and content
(Samples provided for analysis and discussion)
- 10 minutes review
- 10 minutes discussion
Lunch – 30 minutes
Afternoon Session
- Summaries – They Come in Many Flavors
- Say This, Not That – Part 2
How, where, and when to say it
- Break – 15 minutes
- Breakout #3 (Two Groups) – 20 minutes
Rewording poorly written text
(Samples provided for analysis and discussion)
- 10 minutes review
- 10 minutes discussion
Late Afternoon
- Using Hyperlinks
- Writing Clear Conclusions
- Communicating with FDA
- How to ask (and how not to ask) questions
- Refusal to File
- Reviewer’s Guide
- Breakout Session #4 (All Participants) – 20 minutes
- Tricks to Preserve Your Sanity
- Additional Questions
- Closing Slides
Speakers
Arvilla Trag
CMC Compliance Services, Principal Consultant
Ms. Trag is a CMC Compliance and Regulatory professional with over 30 years of experience in biotechnology CMC and GxP compliance. She is experienced in all phases and types of CMC-related regulatory submissions, strategy, and meetings, from IND/IMPD to BLA. She has expertise in CTD Modules 3 and 2.3, comparability strategies and reports, meeting and pre-meeting packages, CMC amendments, CMC regulatory strategy, responding to FDA questions/observations, and due diligence. Product-type experience includes monoclonal antibodies, vaccines, LVP biologics, recombinant proteins, ADCs and some cell therapy. Meeting experience with FDA includes face-to-face and teleconferences for dozens of INDs, BLA submissions, Breakthrough Designation, and CMC amendments. She also provides training on CTD requirements and writing technical documents. Ms. Trag has been Regulatory Affairs Certified since 1994.
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.