Full Schedule

8:00 AM - 9:00 AM EDT

Workshop Breakfast

Room: Harborview

8:00 AM - 4:00 PM EDT

Registration Hours

Room: Atrium

9:00 AM - 4:00 PM EDT

Preconference Workshop: Locating and Analyzing Regulatory Precedent; Incorporating Research and Application Techniques in Strategic Regulatory Decision Making

Room: Columbia/Frederick

Workshop Leader: – Temple University

Workshop Presenter: – Pfizer

Workshop Presenter: – BeOne Medicines

Workshop Presenter: – Genmab US

Combined Track

10:30 AM - 11:00 AM EDT

Workshop Morning Refreshment Break

Room: Harborview

1:00 PM - 2:00 PM EDT

Workshop Lunch Break

Room: Harborview

2:30 PM - 3:00 PM EDT

Workshop Afternoon Refreshment Break

Room: Harborview

8:00 AM - 9:00 AM EDT

Attendee Breakfast

Room: Harborview

8:00 AM - 5:00 PM EDT

Registration Hours

Room: Atrium

9:00 AM - 10:30 AM EDT

Opening Plenary: Unlocking Strategic Advantage: Communicating the Value of Regulatory Intelligence to Decision-Makers

Room: Constellation CDEF

Moderator: – Vertex Pharmaceuticals

Panelist: – Philips

Panelist: – Abbott Laboratories

Panelist: – Kyowa Kirin

Panelist: – Moderna

Combined Track

10:30 AM - 11:00 AM EDT

Coffee & Refreshment Break

Room: Harborview

11:00 AM - 12:00 PM EDT

Building a Regulatory Intelligence Program

Room: Constellation CD

Presenter: – Baxter

Medical Devices (Includes IVDs)

11:00 AM - 12:00 PM EDT

Teaching Regulatory Colleagues "How to Fish" for Regulatory Intelligence

Room: Constellation EF

Presenter: – Eli Lilly and Company

Presenter: – AstraZeneca

Presenter: – Takeda

Pharmaceuticals & Biologics

12:15 PM - 1:15 PM EDT

Regulatory Intelligence in Motion: Embedding Strategic Value Across an Evolving Biopharma Enterprise

Room: Constellation EF

Presenter: – BeOne Medicines

Pharmaceuticals & Biologics

12:15 PM - 1:15 PM EDT

Using the Right KPI’s to Elevate Regulatory Intelligence

Room: Constellation CD

Presenter: – SCIEX

Presenter: – CooperVision

Presenter: – FTI Consulting

Medical Devices (Includes IVDs)

1:15 PM - 2:15 PM EDT

Lunch Break & Sponsored Presentations

Room: Harborview

1:45 PM - 2:10 PM EDT

Sponsor Presentation: How to Build an End-to-End AI-Powered Regulatory Intelligence System

Room: Constellation EF

Sponsor Presenter: – MedBoard

Sponsor Presenter: – CooperVision

1:45 PM - 2:10 PM EDT

Sponsor Presentation: Observe, Interpret, Activate: Scaling Human Expertise in Regulatory Intelligence

Room: Constellation CD

Sponsor Presenter: – Infodesk Inc.

Sponsor Presenter: – UCB

2:15 PM - 2:45 PM EDT

Solutions Circle (3): RI Readiness as a Strategic Advantage: Lessons in Execution Enablement

Room: Frederick

Facilitator: – JA JacksonAgency

Combined Track

2:15 PM - 2:45 PM EDT

Solutions Circle (4): Leveraging Regulatory Intelligence Tools on a Budget

Room: Baltimore

Facilitator: – Stryker

Combined Track

2:15 PM - 2:45 PM EDT

Solutions Circle (5): Map Your Regulatory Intelligence: A Hands-On Session to Understand Your Team’s Strengths and Needs

Room: Baltimore

Facilitator: – Pfizer

Pharmaceuticals & Biologics

2:15 PM - 2:45 PM EDT

Sponsored Solutions Circle (1): From Monitoring to Impact: Making Regulatory Intelligence Actionable

Room: Columbia

Sponsor Presenter: – MPR – Freyr Solutions

2:15 PM - 2:45 PM EDT

Sponsored Solutions Circle (2): From Compliance to Confidence: Leading Regulatory Strategy in the AI Era

Room: Annapolis

Sponsor Presenter: – RegASK

3:00 PM - 4:00 PM EDT

Lost in the Links: What 30 Health Authority Websites Tell Us About Regulatory Transparency

Room: Constellation CD

Presenter: – Pfizer

Pharmaceuticals & Biologics

3:00 PM - 4:00 PM EDT

Navigating Regulatory Strategies for Technology-Based Products: Cybersecurity, PCCPs, and more!

Room: Constellation EF

Presenter: – MedSec LLC

Presenter: – Exponent, Inc.

Medical Devices (Includes IVDs)

4:00 PM - 4:30 PM EDT

Afternoon Refreshment Break

Room: Harborview

4:30 PM - 5:30 PM EDT

Fantastic Regulatory Research and How to Conduct It

Room: Constellation CD

Presenter: – Agency IQ

Presenter: – Stryker

Medical Devices (Includes IVDs)

4:30 PM - 5:30 PM EDT

Knowing What You Already Know: Knowledge Management in Regulatory Intelligence

Room: Constellation EF

Presenter: – Takeda

Presenter: – Vertex Pharmaceuticals

Moderator: – Temple University

Pharmaceuticals & Biologics

5:30 PM - 6:30 PM EDT

Opening Night Networking Reception

Room: Atrium/Harborview

7:00 PM - 9:00 PM EDT

Ticketed Networking Event: Leinie's Lodge and Beer Garden

Room: Leinie's Lodge and Beer Garden

8:00 AM - 9:00 AM EDT

Attendee Breakfast

Room: Harborview

8:00 AM - 4:00 PM EDT

Registration Hours

Room: Atrium

8:30 AM - 9:00 AM EDT

Solutions Circle (2): The Strategic Selection of GenAI Tools for Regulatory Intelligence

Room: Annapolis

Facilitator: – Astrazeneca

Pharmaceuticals & Biologics

8:30 AM - 9:00 AM EDT

Solutions Circle (3): The Swiss Cheese Method: Monitoring, Interpreting, and Communicating the Right Information to the Right Stakeholders

Room: Frederick

Facilitator: – Philips

Medical Devices (Includes IVDs)

8:30 AM - 9:00 AM EDT

Solutions Circle (4): Taming the Regulatory Beast: Mastering Intelligence & Surveillance

Room: Columbia

Facilitator: – Self-Employed

Pharmaceuticals & Biologics

8:30 AM - 9:00 AM EDT

Sponsored Solutions Circle (1): What Will Regulatory Intelligence Look Like in 5–10 Years — and What Should we do About it Now?

Room: Baltimore

Sponsor Presenter: – Cedience

9:15 AM - 10:15 AM EDT

Building Stakeholder Engagement into the Intelligence Program

Room: Constellation CD

Presenter: – Kimberly-Clark

Medical Devices (Includes IVDs)

9:15 AM - 10:15 AM EDT

Towards an E2E Regulatory Intelligence Process

Room: Constellation EF

Presenter: – UCB

Pharmaceuticals & Biologics

10:15 AM - 10:45 AM EDT

Coffee & Refreshment Break

Room: Harborview

10:45 AM - 11:45 AM EDT

Quality Intelligence Function: How Quality is Finding a Seat at the Intelligence Table

Room: Constellation CDEF

Moderator: – Redica Systems

Panelist: – Vertex Pharmaceuticals

Panelist: – Moderna

Panelist: – UCB

Panelist: – Regeneron

Combined Track

12:00 PM - 1:00 PM EDT

Generative AI: Friend or Foe to Regulatory Intelligence

Room: Constellation CDEF

Presenter: – BeOne Medicines

Presenter: – Genmab US

Presenter: – BD

Combined Track

1:00 PM - 2:00 PM EDT

Lunch Break & Sponsored Presentations

Room: Harborview

1:30 PM - 1:55 PM EDT

Sponsor Presentation: Beyond the Alert: Operationalizing Regulatory Intelligence into Actionable Compliance and Competitive Advantage

Room: Constellation CDEF

Sponsor Presenter: – RegDesk

2:00 PM - 3:00 PM EDT

Regulatory Intelligence – Hybrid is the Future

Room: Constellation CDEF

Presenter: – MedBoard

Presenter: – CooperVision

Combined Track

3:00 PM - 3:30 PM EDT

Afternoon Refreshment Break

Room: Harborview

3:30 PM - 4:30 PM EDT

Closing Plenary: The Rise of Agentic AI: Rewriting the Rules of Regulatory Assessment

Room: Constellation CDEF

Moderator: – RegASK

Panelist: – Cedience

Panelist: – MedBoard

Panelist: – University of Maryland

Combined Track