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  • Wednesday, Apr 23rd
    8:00 AM – 8:20 AM East Coast USA Time
    Let's Make a Difference!
    Location: Regency Ballroom – 3rd Floor
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Speaker: Steven Mandernach – Association of Food and Drug Officials (AFDO)
    Speaker: Bill McMoil – Regulatory Affairs Professionals Society, RAPS (Welcome)
    Plenary
  • Wednesday, Apr 23rd
    8:25 AM – 8:55 AM East Coast USA Time
    Patient Experience Plenary #1
    Location: Regency Ballroom – 3rd Floor
    Moderator: Aaron Dunbar – Boston Scientific
    Speaker: John Sperzel, III – T2 Biosystems, Inc.
    Plenary
  • Wednesday, Apr 23rd
    9:00 AM – 9:45 AM East Coast USA Time
    The Solutions Exchange – Culture of Quality
    Location: Regency Ballroom – 3rd Floor
    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
    10:05 AM – 10:50 AM East Coast USA Time
    FDA Medical Device Inspections
    Location: Regency Ballroom – 3rd Floor
    Moderator: Susan Matthias – FDA (Virtual)
    Moderator: Phil Pontikos – Retired, FDA
    Speaker: Anne Reid – FDA (Virtual)
    Speaker: Rhonda Mecl – FDA (Virtual)
    Plenary
  • Wednesday, Apr 23rd
    10:55 AM – 11:40 AM East Coast USA Time
    Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
    Location: Regency Ballroom – 3rd Floor
    Moderator: Aaron Dunbar – Boston Scientific
    Speaker: Kim Kaplan – ISACA
    Speaker: Erin Keith (she/her/hers) – FDA (Virtual)
    Speaker: Roseanne Leaupepe – Fisher & Paykel Healthcare
    Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
    Plenary
  • Wednesday, Apr 23rd
    3:30 PM – 4:15 PM East Coast USA Time
    FDA’s QMSR Implementation Status
    Location: Regency Ballroom – 3rd Floor
    Moderator: Phil Pontikos – Retired, FDA
    Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
    Speaker: Karen Masley-Joseph – FDA (Virtual)
    Plenary
  • Wednesday, Apr 23rd
    4:15 PM – 4:55 PM East Coast USA Time
    Fireside Chat with Industry Leaders
    Location: Regency Ballroom – 3rd Floor
    Moderator: Jessica Zeller – Edwards Lifesciences
    Speaker: Bill Brodbeck – STERIS Corporation
    Speaker: Aaron Dunbar – Boston Scientific
    Speaker: Shannon Hoste – Pathway for Patient Health
    Plenary
  • Wednesday, Apr 23rd
    5:00 PM – 5:05 PM East Coast USA Time
    Close-Out
    Location: Regency Ballroom – 3rd Floor
    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
    Location: Regency Ballroom – 3rd Floor
    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
    Location: Regency Ballroom – 3rd Floor
    Moderator: Fatemeh Razjouyan – Medtronic
    Speaker: Karen Noffs – Anvisa - Brazil
    Speaker: Tammy Steuerwald – Roche
    Plenary
  • Thursday, Apr 24th
    2:25 PM – 3:55 PM East Coast USA Time
    Risk Management - Systems Perspective
    Location: Regency Ballroom – 3rd Floor
    Moderator: Shannon Hoste – Pathway for Patient Health
    Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
    Moderator: Bill Brodbeck – STERIS Corporation
    Speaker: Brian Siroka (he/him/his) – MEDIcept
    Speaker: Evan Markley – Eli Lilly and Company
    Speaker: David Murray – Illumina
    Plenary
  • Thursday, Apr 24th
    4:00 PM – 4:30 PM East Coast USA Time
    Patient Experience #2 Exploring Patient Experience
    Location: Regency Ballroom – 3rd Floor
    Moderator: Shannon Hoste – Pathway for Patient Health
    Speaker: Lane Berlin – Grandview Heights Division of Fire
    Plenary
  • Thursday, Apr 24th
    4:30 PM – 4:40 PM East Coast USA Time
    Day 2 Close
    Location: Regency Ballroom – 3rd Floor
    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
    Location: Regency Ballroom – 3rd Floor
    Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
    Plenary
  • Friday, Apr 25th
    8:10 AM – 9:25 AM East Coast USA Time
    Global Shift in Clinical Expectations
    Location: Regency Ballroom – 3rd Floor
    Moderator: Aaron Dunbar – Boston Scientific
    Moderator: Gert Bos – Qserve Group
    Speaker: Mindy McCann – Qserve Group
    Speaker: Matt Albert – Boston Scientific
    Speaker: Andrew Webster – Zimmer Biomet
    Plenary
  • Friday, Apr 25th
    9:50 AM – 11:20 AM East Coast USA Time
    Investigator Insights
    Location: Regency Ballroom – 3rd Floor
    Moderator: Monica Wilkins – Abbott
    Speaker: Laureen Geniusz – FDA (Virtual)
    Speaker: Susan Matthias – FDA (Virtual)
    Speaker: CDR Tom Peter – FDA (Virtual)
    Speaker: Katelyn Staub-Zamperini – FDA (Virtual)
    Speaker: LCDR Mary Millner – FDA (Virtual)
    Plenary