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Wednesday, March 4, 2026
8:00 AM - 9:00 AM
EDT
Attendee Networking Breakfast
8:00 AM - 9:00 AM
EDT
Attendee Breakfast
Room: Harborview
8:00 AM - 4:00 PM
EDT
Registration Hours
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
8:30 AM - 9:00 AM
EDT
Solutions Circle (2): The Strategic Selection of GenAI Tools for Regulatory Intelligence
Room: Annapolis
Facilitator:
Julia Jiang, RAC
– 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
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:
Bec Swatchick
– Philips
Medical Devices (Includes IVDs)
8:30 AM - 9:00 AM
EDT
Solutions Circle (4): Taming the Regulatory Beast: Mastering Intelligence & Surveillance
8:30 AM - 9:00 AM
EDT
Solutions Circle (4): Taming the Regulatory Beast: Mastering Intelligence & Surveillance
Room: Columbia
Facilitator:
Amanda Lee Broughton, RAC-Drugs
– 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?
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:
Amin Osmani, MSc.
– Cedience
9:15 AM - 10:15 AM
EDT
Building Stakeholder Engagement into the Intelligence Program
9:15 AM - 10:15 AM
EDT
Building Stakeholder Engagement into the Intelligence Program
Room: Constellation CD
Presenter:
Buki Forteau, MLS
– Kimberly-Clark
Medical Devices (Includes IVDs)
9:15 AM - 10:15 AM
EDT
Towards an E2E Regulatory Intelligence Process
9:15 AM - 10:15 AM
EDT
Towards an E2E Regulatory Intelligence Process
Room: Constellation EF
Presenter:
Barbara Bovy, PhD
– UCB
Pharmaceuticals & Biologics
10:15 AM - 10:45 AM
EDT
Coffee & Refreshment Break
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
10:45 AM - 11:45 AM
EDT
Quality Intelligence Function: How Quality is Finding a Seat at the Intelligence Table
Room: Constellation CDEF
Moderator:
Alison Sathe
– Redica Systems
Panelist:
Elayne Kimmett, MBA, CQA, RAC
– Vertex Pharmaceuticals
Panelist:
Joseph M. Thomas, PhD
– Moderna
Panelist:
Barbara Bovy, PhD
– UCB
Panelist:
Heather Buehl
– Regeneron
Combined Track
12:00 PM - 1:00 PM
EDT
Generative AI: Friend or Foe to Regulatory Intelligence
12:00 PM - 1:00 PM
EDT
Generative AI: Friend or Foe to Regulatory Intelligence
Room: Constellation CDEF
Presenter:
Jeff MacDonald, PharmD
– BeOne Medicines
Presenter:
Aleksandr Merenkov, PharmD, MS, MBA
– Genmab US
Presenter:
Jeff Ballyns, PhD
– BD
Combined Track
1:00 PM - 2:00 PM
EDT
Lunch Break & Sponsored Presentations
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
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:
Jodi Lynn Granger
– RegDesk
2:00 PM - 3:00 PM
EDT
Regulatory Intelligence – Hybrid is the Future
2:00 PM - 3:00 PM
EDT
Regulatory Intelligence – Hybrid is the Future
Room: Constellation CDEF
Presenter:
Ivan Perez Chamorro
– MedBoard
Presenter:
Kylie B. Marflak
– CooperVision
Combined Track
3:00 PM - 3:30 PM
EDT
Afternoon Refreshment Break
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
3:30 PM - 4:30 PM
EDT
Closing Plenary: The Rise of Agentic AI: Rewriting the Rules of Regulatory Assessment
Room: Constellation CDEF
Moderator:
Kelli M. Madden, RAC-Drugs
– RegASK
Panelist:
Amin Osmani, MSc.
– Cedience
Panelist:
Ivan Perez Chamorro
– MedBoard
Panelist:
Joga Gobburu, PhD MBA
– University of Maryland
Combined Track