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Full Schedule

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Full Schedule

  • Wednesday, March 6, 2024
  • 7:00 AM – 5:00 PM East Coast USA Time
    Registration
  • 8:00 AM – 9:00 AM East Coast USA Time
    Breakfast - Sponsored by RegASK
  • 9:00 AM – 10:30 AM East Coast USA Time
    Opening Plenary Session: Regulatory Affairs as a Strategic Partner
  • 10:30 AM – 11:00 AM East Coast USA Time
    Coffee Break - Sponsored by PRIA
  • 11:00 AM – 12:00 PM East Coast USA Time
    Current Insights into the FDA Premarket Landscape
  • 11:00 AM – 12:00 PM East Coast USA Time
    The Importance of Precedent in Developing a Regulatory Strategy
  • 12:15 PM – 1:15 PM East Coast USA Time
    The Importance of and Preparing the Target Product Profile (TPP)
  • 12:15 PM – 1:15 PM East Coast USA Time
    Use of Standards in Medical Device Global Regulatory Strategy (Working Title)
  • 1:15 PM – 2:45 PM East Coast USA Time
    Networking Lunch - Sponsored by SGS
  • 2:45 PM – 3:45 PM East Coast USA Time
    Global Patient Safety Teams Should Develop the Study's Target Product Profile Safety Section
  • 2:45 PM – 3:45 PM East Coast USA Time
    In Silico Trials for Device Development and Regulatory Review: Outlining the Need for Global Acceptance
  • 4:00 PM – 5:00 PM East Coast USA Time
    Global Orphan Drug Regulatory Frameworks
  • 4:00 PM – 5:00 PM East Coast USA Time
    In Vitro Diagnostic Medical Devices (Working Title)
  • 5:00 PM – 6:00 PM East Coast USA Time
    Reception with Sponsors