The Food and Drug Administration (FDA) announced the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.”
The purpose of this workshop was to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop was to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness.
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Introduction Slides
StartLengthEndSessionTopic/TitleSpeaker7:00 AM1:008:00 AMRegistrationSecurity screening and pre-registration sign-in 8:00 AM0:058:05 AMWelcomeWelcomeRachel Goehe, PhD8:05 AM0:108:15 AMOpeningOpening RemarksAlberto Gutierrez, PhD8:15 AM0:158:30 AMOverviewWorkshop OverviewLea Carrington, MBA, MS, MT(ASCP) AM SessionSession 1 – Clinician and Patient PerspectivesModerator: Rachel Goehe, PhD8:30 AM0:309:00 AMSession 1Overview of Warfarin TherapyRong Rong, MD, PhD9:00 AM0:309:30 AMSession 1Point-of-Care INR Testing: A Clinician’s PerspectiveMichael Streiff, MD, FACP9:30 AM0:3010:00 AMSession 1POC INR Results and Monitoring of Warfarin Therapy in an Outpatient Based Anticoagulation ClinicPaul T. Kocis, PharmD, RPh, CACP10:00 AM0:1010:10 AMSession 1Patient PerspectiveRandy Fenninger, JD10:10 AM0:1510:25 AMSession 1Patient PerspectiveSue Miller10:25 AM0:1010:35 AMSession 1QA 10:35 AM0:1510:45 AMBREAKBREAK AM SessionSession 2 – Quality AssessmentModerator: Niquiche Sangster-Guity, PhD10:45 AM0:2511:10 AMSession 2POC and Lab INRsMarcia Zucker, PhD11:10 AM0:2511:35 AMSession 2POC PT/INR: Technical Limitations and Laboratory Accreditation IssuesRussell Higgins, MD, FCAP11:35 AM0:2512:00 PMSession 2CLIA and POC PT/INR DevicesSarah Bennett, MT(ASCP)12:00 PM0:1012:10 PMSession 2QA 12:10 PM1:001:10 PMLUNCHLUNCH PM SessionSession 3 – CDRH PerspectivesModerator: Cheng Zhang, PhD, MBA1:10 PM0:351:45 PMSession 3FDA Regulatory Oversight of POC PT/INR DevicesRachel Goehe, PhD Kennita Riddick, MS1:45 PM0:202:05 PMSession 3POC PT/INR Devices for Monitoring Warfarin Therapy: An Overview of Statistical ConsiderationsMeijuan Li, PhD2:05 PM0:452:50 PMSession 3PANEL DISCUSSIONLea Carrington, MBA, MS, MT(ASCP)
Randy Fenninger, JD
Russell Higgins, MD, FCAP
Paul Kocis, PharmD, RPh, CACP
Frank LaDuca, PhD, FAHA
Doug Patterson, MBA
Rong Rong, MD, PhD
Michael Streiff MD, FACP2:50 PM0:103:00 PMSession 3QA 3:00 PM0:103:10 PMBREAKBREAKBREAK Session 4 – Manufacturer PerspectivesModerator: Takeesha Taylor-Bell, H(ASCP)3:10 PM0:153:25 PMSession 4Manufacturer – AccrivaFrank LaDuca, PhD, FAHA3:25 PM0:153:40 PMSession 4Manufacturer – AlereRick San George, PhD3:40 PM0:153:55 PMSession 4Manufacturer – CoaguSenseDoug Patterson, MBA3:55 PM0:154:10 PMSession 4Manufacturer – RocheThomas Bluethner, MS4:10 PM0:104:20 PMSession 4QA 4:20 PM0:304:50 PMPublic CommentPublic Comment 4:50 PM0:105:00 PMWrap UpMeeting Wrap-Up and AdjournLea Carrington, MBA, MS, MT(ASCP)
[email protected].
For questions regarding workshop content please contact:
Rachel Goehe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5533, Silver Spring, MD 20993, 240-402-6565, email: [email protected].