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  • Wednesday, Apr 22nd
    8:00am - 8:30am East Coast USA Time
    Let's Make a Difference
    Plenary
  • Wednesday, Apr 22nd
    8:30am - 9:00am East Coast USA Time
    Patient Experience Plenary #1
    Plenary
  • Wednesday, Apr 22nd
    9:00am - 9:45am East Coast USA Time
    Solutions Exchange: What Works (and doesn’t) When Working With AI
    Moderator: Gert Bos – Qserve Group
    Moderator: John Krug – Eli Lilly and Company
    Plenary
  • Wednesday, Apr 22nd
    10:05am - 10:40am East Coast USA Time
    Update from CDRH’s New Center Director, Michelle Tarver
    Speaker: Gina Bracket – FDA (Invited)
    Plenary
  • Wednesday, Apr 22nd
    10:40am - 11:15am East Coast USA Time
    FDA OII and Office of Medical Device & Radiological Health
    Moderator: Susan Matthias – FDA (Invited)
    Plenary
  • Wednesday, Apr 22nd
    11:15am - 12:15pm East Coast USA Time
    Medical Device User Fee Amendments ( MDUFA) Update
    Moderator: Bill Brodbeck – STERIS Corporation
    Plenary
  • Wednesday, Apr 22nd
    4:20pm - 5:20pm East Coast USA Time
    Managing Material Shortages in a Global Regulatory Landscape
    Speaker: Aaron Dunbar – Boston Scientific
    Plenary
  • Wednesday, Apr 22nd
    5:20pm - 5:25pm East Coast USA Time
    Close Out
    Plenary
  • Thursday, Apr 23rd
    8:00am - 8:10am East Coast USA Time
    Day 2 Open
    Plenary
  • Thursday, Apr 23rd
    8:10am - 8:45am East Coast USA Time
    QMSR Implementation Update
    Moderator: Susan Matthias – FDA (Invited)
    Plenary
  • Thursday, Apr 23rd
    8:45am - 10:10am East Coast USA Time
    Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers
    Moderator: Susan Matthias – FDA (Invited)
    Plenary
  • Thursday, Apr 23rd
    3:20pm - 4:35pm East Coast USA Time
    Global Regulatory Collaboration/Reliance Strategies, Alignment Challenges & “Relianomics” for Medical Devices
    Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
    Plenary
  • Thursday, Apr 23rd
    4:35pm - 5:05pm East Coast USA Time
    Patient Experience Plenary #2
    Plenary
  • Thursday, Apr 23rd
    5:05pm - 5:15pm East Coast USA Time
    Day 2 Close
    Plenary
  • Friday, Apr 24th
    8:00am - 8:05am East Coast USA Time
    Opening Day 3
    Plenary
  • Friday, Apr 24th
    8:05am - 9:05am East Coast USA Time
    How You Can Influence and Support Leadership and a Quality Culture in your Organization!
    Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
    Plenary
  • Friday, Apr 24th
    9:25am - 11:25am East Coast USA Time
    Investigator Insights
    Moderator: Monica Wilkins – Abbott
    Plenary