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Full Schedule

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Full Schedule

  • Wednesday, March 4, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Workshop Breakfast
  • 8:00 AM - 4:00 PM East Coast USA Time
    Registration Hours
  • 9:00 AM - 4:00 PM East Coast USA Time
    Preconference Workshop: Predetermined Change Control Plans (PCCPs) for Medical Devices
  • 10:15 AM - 10:45 AM East Coast USA Time
    Workshop Morning Refreshment Break
  • 1:00 PM - 2:00 PM East Coast USA Time
    Workshop Lunch Break
  • 3:00 PM - 3:30 PM East Coast USA Time
    Workshop Afternoon Refreshment Break
  • Thursday, March 5, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Attendee Breakfast
  • 8:00 AM - 5:00 PM East Coast USA Time
    Registration Hours
  • 9:00 AM - 10:00 AM East Coast USA Time
    Opening Plenary: From Data to Decisions: The Expanding Role of Real‑World Evidence in Regulatory Submissions
  • 10:00 AM - 10:30 AM East Coast USA Time
    Coffee & Refreshment Break
  • 10:30 AM - 11:30 AM East Coast USA Time
    Biomedical Ethical Concerns of Artificial Intelligence-Driven Diagnosis in Precision Medicine
  • 10:30 AM - 11:30 AM East Coast USA Time
    When the Model Becomes the Molecule: Regulating AI in Drug Development
  • 10:45 AM - 12:45 PM East Coast USA Time
    From Change to Clearance: Leveraging Predetermined Change Control Plans to Accelerate Regulatory Approvals and Innovation
  • 11:45 AM - 12:45 PM East Coast USA Time
    Regulatory Considerations and Strategies for the Use of Artificial Intelligence in US Advertising and Promotion
  • 12:45 PM - 1:45 PM East Coast USA Time
    Lunch and Sponsored Presentations
  • 1:15 PM - 1:40 PM East Coast USA Time
    Sponsored Presentation: Making Your SOTA and Device Literature Search Count: The Expectation Values of the Notified Bodies on Literature Searches.
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: AI to Securely Cut IND Assembly Time to Quality
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: From Chaos to Compliance: Scaling MLR Systems for Global Readiness
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: How Can a Strong Quality System Support Manufacturers’ Regulatory Strategy?
  • 2:30 PM - 3:30 PM East Coast USA Time
    From Risk to Readiness: Lessons Learned in Medical Device Cybersecurity Documentation for FDA Submissions”
  • 2:30 PM - 3:30 PM East Coast USA Time
    Gen AI Era: Evolving Landscape of Regulatory Affairs for Cell and Gene Therapy
  • 3:30 PM - 4:00 PM East Coast USA Time
    Afternoon Refreshment Break
  • 4:00 PM - 5:00 PM East Coast USA Time
    From Nonconformities to Insight: Leveraging Biocompatibility Assessment Trends for Regulatory Intelligence and Strategic Compliance
  • 4:00 PM - 5:00 PM East Coast USA Time
    Reimagining Global Regulatory Strategy for Agility and Impact
  • 5:00 PM - 6:00 PM East Coast USA Time
    Opening Night Networking Reception
  • 6:30 PM - 8:30 PM East Coast USA Time
    Ticketed Networking Event: Leinie's Lodge and Beer Garden
  • Friday, March 6, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Networking Breakfast
  • 8:00 AM - 12:00 PM East Coast USA Time
    Registration Hours
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: Global Regulatory Strategy for Orphan Early Stage Drug Development
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: Managing the Lifecycle for Artificial Intelligence in Medicine
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
  • 9:15 AM - 10:15 AM East Coast USA Time
    From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
  • 9:15 AM - 10:15 AM East Coast USA Time
    QMS for Adaptive AI/ML Devices: What You Can’t Miss
  • 10:15 AM - 10:45 AM East Coast USA Time
    Coffee & Refreshment Break
  • 10:45 AM - 11:45 AM East Coast USA Time
    Devices that Help: Demystifying the Regulatory Expectations Around Showing “Benefit”
  • 10:45 AM - 11:45 AM East Coast USA Time
    No Site, No Problem? Regulating Evidence in a Decentralized Trial World
  • 12:00 PM - 1:00 PM East Coast USA Time
    Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
  • 12:00 PM - 1:00 PM East Coast USA Time
    Global Registration Planning Consideration: Integrated Strategy to Solve the Complex Registration Sample Challenge
  • 1:00 PM - 2:00 PM East Coast USA Time
    Lunch and Sponsored Presentations
  • 2:00 PM - 3:00 PM East Coast USA Time
    Chasing an Easier Method for Specific PMPF: Can Surveys Play a Role?
  • 2:00 PM - 3:00 PM East Coast USA Time
    Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products
  • 3:00 PM - 3:30 PM East Coast USA Time
    Afternoon Refreshment Break
  • 3:30 PM - 4:30 PM East Coast USA Time
    Closing Plenary: The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI