RAPS Workshop: Module 3 Preparation with the Reviewer in Mind

Registration Fees & Deadlines

Learning Objectives

• Learn to identify where specific information belongs in Module 3, how to make text and tables flow logically, and data organization tips.

• Understand ways to word information that avoid misunderstandings and unintentional commitments

• 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. A review of Module 3 basics (structure and organization)

15-minute break

1. Module 3 by Clinical Phase requirements

Task 1 (group break-outs): Phase-appropriate submission structure and content (Samples provided for analysis and discussion)} {Questions and Discussion}

1. What to Write – Say This, Not That
1. Basic Rules About Submission Text
2. Data Presentation Standards

{Lunch – 1 hour}

1. What to Write – Say This, Not That, continued  
1. Choosing Your Words –how you say it matters 
2. Choosing Your Section – where you say it matters 
3. Writing Clear Conclusions 
4. Using Links

15-minute break

{Task 2 (group break-outs: Rewording poorly written text (samples provided for analysis and discussion)}

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