RAPS Workshop: Module 3 Preparation with the Reviewer in Mind

The goal of any submission to a global health authority such as the US Food and Drug Administration (FDA) or European Medicines Agency (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 virtual event, participants will learn how to provide structure and content to Module 3 of the Common Technical Document (CTD) that will facilitate review and avoid frustrating reviewers. An expert presenter will give recommendations for creating data tables that are easy for health authority reviewers to understand, figures that are clean and clearly labeled, and wording that is uncomplicated and easy to read.

Attendees will learn about common submission mistakes and how to avoid them, along with strategies for avoiding requests for information that can delay approval. In group breakouts, attendees will analyze and discuss redacted samples from actual submissions. And while this session will focus mainly on Module 3, the lessons you learn in this workshop can be extrapolated to other modules.

Registration Fees & Deadlines

Present – 12 January 2025: Member $440 | Nonmember $520
12 January to 12 February 2025: Member $520 | Nonmember $610

Learning Objectives

• Be able to identify where specific information belongs in Module 3, how to make text and tables flow logically, and data organization tips.
• Be able to word information to avoid misunderstandings and unintentional commitments.
• Understand common understand submission mistakes to avoid and how to make the submission more reviewer-friendly, resulting in improved outcomes.

Who Should Attend?

• Regulatory professionals and technical writers who want to improve their technical writing skills
• Anyone new to technical writing for industry 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

1. Initial Break-out Session – everyone; 15 minutes
2. Why this topic?
3. A review of Module 3 basics (structure and organization)
4. Module 3 by Clinical Phase requirements, Part 1
5. The Process Flow Diagram

15-minute break

1. Module 3 by Clinical Phase requirements, Part 2
2. Comparability reporting in S.2.6

Break-out #2 (2 groups): Phase-appropriate submission structure and content (Samples provided for analysis and discussion)} {Questions and Discussion} 10 min to review; 10 min to discuss

{Lunch – 30 min}

1. Summaries – they come in many flavors
2. Say this, Not That, Part 2 (how, where and when to say it)

15-minute break)

Break-out #3 (2 groups): Rewording poorly written text (samples provided for analysis and discussion) 10 min to review; 10 min to discuss

1.  Using Hyperlinks
2. Writing Clear Conclusions
3.  Communicating with FDA
1. How to ask (and how not to ask) questions of FDA
2.  Refusal to File
3.  Reviewer’s Guide

Break-out Session #4 - everyone; 20 minutes

1. Tricks to Preserve Your Sanity

{any additional questions}

Closing slides

Speakers

Arvilla Trag
CMC Compliance Services, Principal Consultant 

With over 30 years of experience in biotechnology CMC and GxP compliance, Arvilla Trag 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. Her 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. She earned her Regulatory Affairs Certification (RAC) in 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