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  • Wednesday, Apr 23rd
    8:00 AM – 8:20 AM East Coast USA Time
    Let's Make a Difference!
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Wednesday, Apr 23rd
    8:25 AM – 8:55 AM East Coast USA Time
    Patient Experience Plenary #1
    Moderator: Aaron Dunbar – Boston Scientific
    Speaker: John Sperezel – T2 Biosystems
    Plenary
  • Wednesday, Apr 23rd
    9:00 AM – 9:30 AM East Coast USA Time
    The Solutions Exchange – Culture of Quality
    Moderator: John Krug – Eli Lilly and Company
    Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
    Moderator: Jessica Zeller – Edwards Lifesciences
    Plenary
  • Wednesday, Apr 23rd
    9:50 AM – 10:25 AM East Coast USA Time
    Center Director Corner: CDRH Strategic Priorities and Initiatives for 2025 and Beyond
    Plenary
  • Wednesday, Apr 23rd
    10:30 AM – 11:05 AM East Coast USA Time
    FDA Medical Device Inspections
    Moderator: Phil Pontikos – FDA
    Speaker: Anne Reid – FDA (Virtual)
    Speaker: Rhonda Mecl – FDA (Virtual)
    Plenary
  • Wednesday, Apr 23rd
    11:10 AM – 11:40 AM East Coast USA Time
    FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
    Moderator: Gina Brackett – FDA (Invited)
    Moderator: Susan Matthias – FDA (Virtual)
    Speaker: Rhonda Mecl – FDA (Virtual)
    Speaker: Commander Cesar Perez – FDA (Invited)
    Speaker: Anne Reid – FDA (Virtual)
    Plenary
  • Wednesday, Apr 23rd
    11:45 AM – 12:15 PM East Coast USA Time
    Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
    Moderator: Aaron Dunbar – Boston Scientific
    Speaker: Kim Kaplan
    Speaker: Erin Keith – FDA (Invited)
    Speaker: Brian Schultz – Fisher & Paykel Healthcare
    Speaker: Keisha Thomas – FDA (Invited)
    Plenary
  • Wednesday, Apr 23rd
    4:20 PM – 5:05 PM East Coast USA Time
    TBD
    Plenary
  • Wednesday, Apr 23rd
    5:10 PM – 5:15 PM East Coast USA Time
    Close-Out
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Thursday, Apr 24th
    8:00 AM – 8:10 AM East Coast USA Time
    Opening Day 2
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Thursday, Apr 24th
    8:15 AM – 9:30 AM East Coast USA Time
    Breaking Barriers: The Power of Regulatory Reliance
    Moderator: Fatemeh Razjouyan – Medtronic
    Speaker: Melissa Torres – FDA (Invited)
    Speaker: Karen Noffs – Anvisa
    Speaker: Tammy Steuerwald – Roche
    Plenary
  • Thursday, Apr 24th
    2:25 PM – 4:25 PM East Coast USA Time
    FDA Mock Inspection
    Moderator: Phil Pontikos – FDA
    Speaker: Laureen Geniusz – FDA
    Speaker: Benjamin Dastoli – FDA
    Speaker: Bill Brodbeck – STERIS Corporation
    Plenary
  • Thursday, Apr 24th
    4:30 PM – 5:00 PM East Coast USA Time
    Patient Experience #2 Exploring Patient Experience
    Moderator: Shannon Hoste – Pathway for Patient Health
    Speaker: Lane Berlin – Grandview Heights Division of Fire
    Plenary
  • Thursday, Apr 24th
    5:00 PM – 5:10 PM East Coast USA Time
    Day 2 Close
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Friday, Apr 25th
    8:00 AM – 8:05 AM East Coast USA Time
    Opening Day 3
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Friday, Apr 25th
    8:10 AM – 9:10 AM East Coast USA Time
    Global Shift in Clinical Expectations
    Moderator: Aaron Dunbar – Boston Scientific
    Moderator: Gert Bos – Qserve Group
    Speaker: Kevin Escapule – Zimmer Biomet
    Speaker: Mindy McCann – Qserve Group
    Speaker: Matt Albert – Boston Scientific
    Plenary
  • Friday, Apr 25th
    9:35 AM – 11:35 AM East Coast USA Time
    Investigator Insights
    Moderator: Monica Wilkins – Abbott
    Speaker: Benjamin Dastoli – FDA
    Speaker: Laureen Geniusz – FDA
    Speaker: Phil Pontikos – FDA
    Plenary