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Full Schedule

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Full Schedule

  • Friday, November 14, 2025
  • 8:00 AM - 8:10 AM East Coast USA Time
    Day 2 Opening
  • 8:10 AM - 9:25 AM East Coast USA Time
    Navigating Human Factors for Combination Products, Including Generic: URRA, Threshold Analysis and Post Market
  • 9:25 AM - 9:50 AM East Coast USA Time
    BREAK
  • 9:50 AM - 10:50 AM East Coast USA Time
    Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management
  • 10:55 AM - 12:10 PM East Coast USA Time
    Drug-Delivery Device Clinical Bridging: Leverage Platform Approach and Prior Knowledge
  • 12:10 PM - 1:10 PM East Coast USA Time
    LUNCH
  • 1:15 PM - 2:30 PM East Coast USA Time
    Navigating Clinical Strategies for Combination Products with Investigational Devices
  • 2:35 PM - 3:35 PM East Coast USA Time
    FDA Fireside Chat
  • 3:35 PM - 3:45 PM East Coast USA Time
    Summit Close-Out