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Full Schedule

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Full Schedule

  • Friday, March 6, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Networking Breakfast
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: How Can a Strong Quality System Support a Manufacturer's Regulatory Strategy?
  • 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
    Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products
  • 2:00 PM - 3:00 PM East Coast USA Time
    New Session Topic: Post-Market Performance Follow-up & Post-Market Surveillance
  • 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: Biomedical Ethical Concerns of Artificial Intelligence-Driven Diagnosis in Precision Medicine