RAPS Workshop: To Pre-Sub, or Not to Pre-Sub, That Is the Question

This workshop is designed to help you understand what the FDA Pre-submission (Pre-Sub) program is and how and when to use it most effectively. Learn practical tips from industry experts who have been successfully navigating the Pre-Sub program since its inception, including strategies to truly listen to what FDA is saying (or not saying), and how to handle inevitable disagreements.

Key topics will include:

• Pre-sub history
• Making the pre-sub decisions (To Pre-Sub or Not to Pre-Sub, Written Feedback or Meeting, Video or In-Person Meeting)
• What makes a good pre-sub (Content, Questions, Presentation, Attendees)
• The art of pre-sub communications (Understanding FDA, Handling Disagreements, Avoiding Multiple Pre-Subs, Meeting Minutes)
• Best practices and lessons learned
• Questions and answers

Learning Objectives

• Understand the purpose and scope of pre-submissions
• Identify appropriate situations for initiating a pre-submission (pre-sub) vs. proceeding directly with submission
• Prepare complete and high-quality pre-submission requests including development of effective questions
• Develop and execute a strategic plan to effectively prepare for a pre-submission meeting
• Understand techniques to engage in productive interactions with FDA during the pre-submission process
• Interpret and integrate FDA feedback into the regulatory strategy and premarket submission

Who Should Attend?

Regulatory Affairs Professionals:

• Regulatory Affairs Specialist
• Regulatory Affairs Manager
• Regulatory Affairs Director
• Medical Device Executives needing to understand the strategy behind Pre-Subs
• Clinical Affairs Professionals of all levels

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.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Agenda

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 [email protected]. 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 [email protected] 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 [email protected].

Speaker

Mark DuVal JD, FRAPS

CEO, DuVal & Associates, P.A.

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Lisa Pritchard BSEEE, FRAPS

VP of Regulatory, Quality, Clinical & Engineering , DuVal & Associates, P.A.

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Kathy Herzog BSME

Sr. Regulatory, Quality, and Compliance Associate, DuVal & Associates, PA

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Patrick Axtell Ph.D.

Assistant Director, Tools & Templates Team, CDRH, RP/DRP4, , US Food and Drug Administration

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Susannah Gilbert Sc.M.

Assistant Director PMA, HDE, Q-Submission and Device Tracking Lifecycle Team, U.S. Food and Drug Administration United States Department of Health & Human Services