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Full Schedule

  • Wednesday, November 12, 2025
  • 8:45 AM - 11:30 AM East Coast USA Time
    Workshop: Hot Topics for Combination Products
  • 10:00 AM - 10:15 AM East Coast USA Time
    BREAK
  • 11:30 AM - 12:30 PM East Coast USA Time
    LUNCH
  • 12:30 PM - 3:00 PM East Coast USA Time
    Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions
  • 3:00 PM - 3:15 PM East Coast USA Time
    BREAK
  • 3:15 PM - 5:15 PM East Coast USA Time
    EDDO
  • Thursday, November 13, 2025
  • 8:00 AM - 8:20 AM East Coast USA Time
    Let's Make a Difference
  • 8:20 AM - 9:05 AM East Coast USA Time
    The Solutions Exchange
  • 9:10 AM - 9:55 AM East Coast USA Time
    From the Desk of the Office of Combination Products - Strategic Priorities
  • 9:55 AM - 10:20 AM East Coast USA Time
    BREAK
  • 10:20 AM - 11:20 AM East Coast USA Time
    Global Harmonization in the Diverging Combination Products Space
  • 11:25 AM - 12:25 AM East Coast USA Time
    Clinical Investigations for Combined Use Systems
  • 12:25 PM - 1:40 PM East Coast USA Time
    LUNCH
  • 1:40 PM - 2:25 PM East Coast USA Time
    Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle
  • 2:30 PM - 3:30 PM East Coast USA Time
    Under Control: Combination Products Control Strategies and Best Practices
  • 3:30 PM - 3:55 PM East Coast USA Time
    BREAK
  • 3:55 PM - 4:55 PM East Coast USA Time
    Challenges of Supplier & Partner Relationships
  • 4:55 PM - 5:05 PM East Coast USA Time
    Close Out
  • 5:30 PM - 7:00 PM East Coast USA Time
    Networking Reception
  • 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