Closing Plenary: The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI

Description: In 2016, Geoffrey Hinton warned us to stop training radiologists. Tech leaders predicted that in two years, we’d be in self-driving cars. Nearly a decade later, radiologists are still driving and so are regulatory professionals.

But the landscape is shifting. Regulatory bodies are digitizing submission tools. Platforms like e-Star and FDA’s Elsa signal a future where AI tools are the norm. Are regulatory
professionals prepared?

This panel brings together experienced regulatory leaders, former FDA regulators, and consultants with deep expertise in AI/ML, global submissions, and digital health to discuss the evolution of regulatory careers, the skill sets professionals need today, and what it means to be “AI literate” in an increasingly tech-driven regulatory space. We will explore the shift from “accidental” regulatory careers to strategic, technology-enabled professional pathways, and how formalized education must evolve to include digital tools, AI awareness, and strategic technology integration.

Discussion Topics & Questions for Panelists
1. How has the regulatory profession changed in the last decade?
2. What new competencies–technical, strategic, and digital–are critical for today’s regulatory professionals?
3. What does “AI literacy” look like in practice for regulatory strategy, submissions, and review?
4. How should academic programs and corporate training evolve to include AI
concepts?
5. What criteria should regulatory professionals use to assess AI-enabled platforms and tools in a regulatory context?

Key Themes
1. From chance to choice: the formalization and intentionality of regulatory careers
2. Regulatory strategy in the era of digital transformation
3. Critical thinking, attention to detail–and now, prompt engineering
4. Building and upskilling the regulatory workforce for an AI-driven future