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  • Wednesday, Mar 6th
    11:00 AM – 12:00 PM East Coast USA Time
    Current Insights into the FDA Premarket Landscape
    Location: Concourse C/D
    Presenter: Melissa Hall, MSc (she/her/hers) – Statera Regulatory Consulting, LLC
    Presenter: Caroline Rhim, PhD – Evera Regulatory Advisors
    Medical Device/IVD
  • Wednesday, Mar 6th
    12:15 PM – 1:15 PM East Coast USA Time
    Use of Standards in Medical Device Global Regulatory Strategy
    Location: Concourse C/D
    Presenter: Susumu Nozawa, RAC, FRAPS – Siemens Healthineers
    Medical Device/IVD
  • Wednesday, Mar 6th
    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
    Location: Concourse C/D
    Presenter: Marc Horner, PhD – Ansys
    Medical Device/IVD
  • Wednesday, Mar 6th
    4:00 PM – 5:00 PM East Coast USA Time
    In Vitro Diagnostic Medical Devices
    Location: Concourse C/D
    Medical Device/IVD
  • Thursday, Mar 7th
    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
  • Thursday, Mar 7th
    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
  • Thursday, Mar 7th
    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