Freyr ONE USA 2026

As AI becomes embedded across the life sciences value chain, regulatory teams have an opportunity to move from operational support functions to strategic enablers of innovation. This keynote explores how regulatory, R&D, and digital functions can work together to accelerate development, improve decision-making, and deliver better business outcomes.

What does the next-generation regulatory enterprise look like? This session presents a vision for connecting domain expertise, digital capabilities, & enterprise data into a unified operating model. Through real-world use cases, platform demos, & customer perspectives, we see how AI, intelligence, & connected workflows can help organizations improve productivity, compliance & business agility.

Regulatory organizations generate enormous amounts of data, but turning it into actionable intelligence remains a significant challenge. This session shows how modern intelligence platforms, analytics, & AI agents can transform fragmented information into meaningful business insights. We see how organizations can move from reporting historical activity to driving proactive decisions and strategic actions.

Regulatory leaders from across industries discuss the challenges shaping today's operating environments and the lessons they are carrying into the future. Topics include workforce evolution, operating models, technology adoption, organizational readiness, and leadership priorities. The session provides insights into what is working today, what organizations continue to struggle with, and how leading companies are preparing for the future.

This session examines how leading organizations are rethinking the role of RIM to support greater agility, intelligence, and cross-functional collaboration. The discussion covers emerging business needs, adoption challenges, and the capabilities required to unlock greater value from regulatory information investments.

Post-Approval Change Management remains one of the most complex and resource-intensive regulatory processes. This session demonstrates how agentic AI can automate planning, impact assessments, workflow orchestration, and execution across the PACS lifecycle. Attendees experience an end-to-end demonstration that illustrates how intelligent agents can augment regulatory teams, reduce manual effort, and accelerate decision-making.

The future of regulatory organizations will not simply be defined by technology, but by how people, processes, data, and AI work together. Industry leaders discuss how operating models must evolve to support greater speed, scalability, intelligence, and business alignment. Topics include organizational design, talent transformation, governance, data strategy, and the role of AI in shaping the regulatory function of the future.