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Full Schedule

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Full Schedule

11 results found

  • Thursday, March 7, 2024
  • 7:00 AM – 12:00 PM East Coast USA Time
    Registration
    Location: Foyer C/D
  • 8:00 AM – 9:00 AM East Coast USA Time
    Breakfast with Sponsors
    Location: Foyer B/C
  • 9:00 AM – 10:00 AM East Coast USA Time
    Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
    Location: Concourse B
    Presenter: Rob Berlin, JD/MPH – GSK
    Presenter: Rasika Kalamegham, PhD – Genentech
    Presenter: Jeff Siegel, MD (he/him/his) – FDA
    Pharma/Biologics
  • 9:00 AM – 10:00 AM East Coast USA Time
    How Do I Get/Keep My IVD Device on the European Market?
    Location: Concourse C/D
    Presenter: Stefan Burde, PhD (he/him/his) – TÜV SÜD
    Medical Device/IVD
  • 10:00 AM – 10:30 AM East Coast USA Time
    Coffee Break with Sponsors
    Location: Foyer B/C
  • 10:30 AM – 11:30 AM East Coast USA Time
    Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
    Location: Concourse C/D
    Presenter: Karen Zhou, JD, MS, RAC – Northeastern University
    Presenter: Ginny K. Gattinger, MS, RAC – SoftwareCPR
    Medical Device/IVD
  • 10:30 AM – 11:30 AM East Coast USA Time
    Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
    Location: Concourse B
    Presenter: Rob Berlin, JD/MPH – GSK
    Presenter: Eva Temkin
    Pharma/Biologics
  • 11:45 AM – 12:45 PM East Coast USA Time
    Building Sustainable Ways of Maintaining a Solid Regulatory Strategy
    Location: Concourse C/D
    Presenter: Amra Racic, NA – Veeva Systems
    Medical Device/IVD
  • 11:45 AM – 12:45 PM East Coast USA Time
    Thinking Beyond Regulatory Approval: The What, Why, When, and How of Pharma Lifecycle Management
    Location: Concourse B
    Pharma/Biologics
  • 12:45 PM – 2:15 PM East Coast USA Time
    Lunch with Sponsors
    Location: Foyer B/C
  • 2:15 PM – 3:30 PM East Coast USA Time
    Closing Plenary Session: How Cybersecurity and AI Have Changed the Regulatory Strategy Environment
    Location: Concourse B
    Presenter: Michelle Jump, RAC – MedSec LLC
    Presenter: Amra Racic, NA – Veeva Systems
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