RAPS Workshop: From Data Overload to Strategic Advantage: AI Solutions for Regulatory Excellence

Transform your regulatory workflows from time-consuming manual searches to strategic, data-driven decision-making. This interactive three-hour workshop demonstrates how AI-powered tools are revolutionizing medical device regulatory processes, turning decades of fragmented data into actionable insights.

At this virtual event, expert speakers will lead you through:

Real case studies showing $300K cost savings, accelerated FDA approvals, and streamlined predicate searches
Live demonstrations of AI tools for regulatory database analysis, adverse event trending, and precedent research
Hands-on practice with scenarios relevant to your daily challenges
Implementation roadmap to integrate AI solutions into your existing workflows

You will leave this workshop with a list of tools you can start to implement right away.

Learning Objectives

At the conclusion of this workshop, participants should be able to:

Identify specific AI applications that address their current regulatory challenges
Evaluate the ROI potential of AI-powered regulatory tools
Develop an implementation strategy for their organization

Who Should Attend?

Medical Device professionals who are interested in:

Regulatory Intelligence/Strategy/Policy
Regulatory writing/documentation
Post Market Surveillance/Risk Management

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

Who is the intended audience?

Medical Device professionals who are interested in:

Regulatory Intelligence/Strategy/Policy
Regulatory writing/documentation
Post Market Surveillance/Risk Management

Agenda

Time	Topic
10:00 AM – 10:05 AM	Introduction (5 min) Welcome and introductions Workshop goals, expected outcomes, and how to participate (Q&A, Zoom functions, etc.)
10:05 – 10:50 AM	Session 1: Practical use cases and examples from first-hand experience of working with hundreds of users in regulatory strategy, regulatory consulting, and intelligence Lauren Naficy
10:50 – 11:05 AM	Session 1 Questions and Answers
11:05 – 11:10 AM	Break
11:10 AM – 11:55 PM	Session 2 A practitioner’s journey as an experienced regulatory professional, how to evaluate, learn, and implement AI tools in day-to-day work Strategic guidance in a startup context: speed with confidence Pre-Sub preparation: comparison of similar products, requirements, standards, informed Qsub, and meaningful discussion Risk management: analysis of similar products to guide the probability of occurrence for hazardous situations in novel products Post-market surveillance: adverse event trending, recalls, and signal detection Teaching perspective at USCS Silicon Valley Extension Leena Kadakia
11:55 – 12:10 PM	Session 2 Questions and Answers
12:10 – 12:15 PM	Break
12:15 – 12:45 PM	Session 3 The "Big Three" Snapshot: Compare ChatGPT, Gemini, and Copilot, and learn how to choose the right tool for the right regulatory tasks. 10-Minute Adoption Audit: A quick framework to validate if a tool adds value or unnecessary risk. Avoid the trap of “Using AI for the Sake of Using AI”. Augment, Don’t Replace: Enhance expert judgment in RA/QA, avoid brain rot. Michelle Wu
12:45 – 1:00 PM	Final Q&A, wrap-up, and next steps (15 min)

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.