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RAPID Phase II/III Working Group Meeting

May 25

Registry Assessment of Peripheral Interventional Devices (RAPID)
Phase II/III Working Group Meeting 

Be Part of the Launch Team!

RAPID May 25 Agenda Final

Meeting Recording (Audio Only)

08:00-08:30 Welcome and Updates

  • Welcome Mitchell Krucoff, Duke University / MDEpiNet

08:30-9:45 Leveraging National Data Models & Terminologies for Medical Device Evaluation

              Moderator:  James Tcheng, Duke University

  • Lead Discussants

Michael Nguyen, US FDA / Center for Drug Evaluation and Research (CDER) / Sentinel Program Lead / CDR, US Public Health Service

Gregory Pappas, US FDA / CDRH, Associate Director for National Devices Surveillance

  • Group Discussion: Opportunities for RAPID

9:45-10:00 BREAK

10:00-11:00   Inaugural RAPID Phase II/III Research Project

              Moderator:  Robert Thatcher, 4C Medical Technologies

  • Status of RAPID CDE Implementation by Registries, EMRs, Industry

Lead Discussants:

Jens Jorgensen, Maine Medical Center, Vascular Quality Initiative (VQI)

Ralph Brindis, University of California, San Francisco / National Cardiovascular Data Registry (NCDR)

Ahmed Saad, MedStreaming LLC

Ronnie Bunshaft, Epic Systems Corporation

Patrick Wang, Medtronic

  • Group Discussion

11:00-12:15 Methods for Data Capture, Integration, Exchange, & Management

Moderator: Brian McCourt, Duke Clinical Research Institute

  • Current Experience: Successes and Challenges

Lead Discussants:

       UDI Data Collection

Barry Daniels, GMDN

Kin-Wah Fung, National Library of Medicine

Registry Data Collection

Daniel Bertges, University of Vermont, VQI

Ralph Brindis, NCDR

EMR Discrete Data Element Collection:

Ronnie Bunshaft, Epic Systems Corporation

Ahmed Saad, MedStreaming LLC

Industry Implementation of UDI:

Aaron Lottes, Cook Medical

  • Group Discussion

12:30-1:30    Working Lunch:  Funding RAPID Phase II/III 

Moderator: Mitchell Krucoff, Duke Clinical Research Institute

  • Group Discussion

13:30-14:30 Methods for Data Aggregation, Analysis and Sharing with Industry and FDA

Moderator: Danica Marinac-Dabic, US FDA / CDRH, Director of the Division of Epidemiology

  • Group Discussion

14:30 – 15:45 Multi-Stakeholder Benefits from RAPID

Moderator:  Pablo Morales, US FDA / CDRH, Medical Officer

  • Perspectives

Misti Malone, US FDA / CDRH, Chief Peripheral Interventional Devices Branch

Daniel Canos, Centers for Medicare & Medicaid Services (CMS)

Mera Choi, Office for the National Coordinators for Health Information Technology (ONC)

Josh Smale, Bard Peripheral Vascular

Joni Creal, Bard Peripheral Vascular

  • Group Discussion

15:45 – 16:30 Planning Next Steps

Moderators:  Mera Choi, Jack Cronenwett, Pablo Morales, Robert Thatcher

  • Working Groups, Timeline & Next Meeting

16:30 Adjourn

RAPID Meeting Logistics

Phase I of RAPID, the 100 minimum core data elements for device evaluation of devices in PAD, was delivered ahead of schedule. On May 25, 2017, the Phase II implementation of these data elements into electronic registries and health records will be complemented by the acceleration of Phase III: the first clinical device trials using this structured approach to real world evidence quality and efficiency.
Join FDA, ONC, VQI, NCDR, SIR, VIVA, EPIC and the VA along with other informatics experts in laying out the road map solutions of working steps and timelines for implementation of the minimum core data elements to support device evaluation emerging from real world evidence that “dual purposes” rather than “doubles” site-based work flow.
Join the broad base of device manufacturers, regulators and clinicians in developing the first clinical trials emerging to support regulatory decisions in the PAD space using these principles of quality and efficiency aligned with the overall directions and priorities of the National Evaluation System for health Technologies (NEST).
Join the pre-competitive, collaborative RAPID working group within the MDEpiNet Public Private Partnership in Silver Spring Maryland on 25-May!
Limited onsite registration will be available first come/first served.

Confirmed Speakers

Daniel Bertges, MD
University of Vermont Health System
Society for Vascular Surgery, Vascular Quality Initiative
Aaron Lottes, PhD
Cook Medical
Ralph Brindis, MD, MPH
University of California, San Francisco
National Cardiovascular Data Registry (NCDR)
William Maisel, MD MPH
US Food and Drug Administration
Jeffrey Brown, PhD
Harvard Pilgrim Healthcare Institute
Harvard Medical School
Misti Malone, PhD
US Food and Drug Administration
Ronnie Bunshaft
Epic Systems Corporation
Danica Marinac-Dabic, MD, PhD
US Food and Drug Administration
Daniel Canos, PhD, MPH
Centers for Medicare and Medicaid Services (CMS)
Brad Martinsen, PhD
Cardiovascular Systems, Inc.
Mera Choi, JD
Office of the National Coordinator for
Health Information Technology (ONC)
Brian McCourt
Duke Clinical Research Institute
Joni Creal, MS
Bard Peripheral Vascular
Behnaz Minaei, MSC
US Food and Drug Administration
Jack Cronenwett, MD
Dartmouth-Hitchcock Medical Center
Society for Vascular Surgery, Vascular Quality Initiative
Pablo Morales, MD
US Food and Drug Administration
Barry Daniels, MB
Global Medical Device Nomenclature (GMDN)
Michael Nguyen, MD
US Food and Drug Administration
Rachael Fleurence, PhD
Medical Device Innovation Consortium (MDIC),
National Medical Device Evaluation System (NEST)
Gregory Pappas, MD, PhD
US Food and Drug Administration
Kin-Wah Fung, MD
National Library of Medicine, National Institutes of Health
Ahmed Saad
MedStreaming
Stanley Huff, MD
Intermountain Healthcare
Healthcare Services Platform Consortium (HSPC)
Josh Smale
Bard Peripheral Vascular
Jens Jorgensen, MD
Maine Medical Center
Society for Vascular Surgery, Vascular Quality Initiative
James Tcheng, MD
Duke University
Mitchell Krucoff, MD
Duke Clinical Research Institute
Robert Thatcher
4C Medical Technologies

Registered Organizations

Federal Partners, Policy & Standards Organizations

Agency for Healthcare Research & Quality (AHRQ)
Centers for Medicare and Medicaid Services (CMS)
Office of the National Coordinator for Health Information Technology (ONC)
National Library of Medicine, National Institutes for Health
US Food and Drug Administration, Center for Drug Evaluation and Research (US FDA, CDER)
US Food and Drug Administration, Center for Devices & Radiologic Health (US FDA, CDRH)
Duke-Margolis Center for Health Policy
GMDN Agency
Healthcare Services Platform Consortium (HSPC)

Healthcare, Research & Professional Societies

Dartmouth-Hitchcock Medical Center
Duke University
Harvard Pilgrim Health Care Institute
Intermountain Healthcare
University of Vermont Medical Center
Global Clinical Programs
OEIS National Registry
National Cardiovascular Data Registry (NCDR)
Medical Device Innovation Consortium (MDIC)
National Evaluation System for health Technology (NEST)
Boston Biomedical Associates
Duke Clinical Research Institute (DCRI)
INC Research
American College of Cardiology (ACC)
Society for Interventional Radiology (SIR)
Society for Vascular Surgery, Vascular Quality Initiative (SVS, VQI)

 

Medical Device & HIT Industry

4C Medical Technologies
Abbott
Aorta Medical Inc
BARD Peripheral Vascular Inc.
Boston Scientific
Cardiovascular System, Inc.
Cook Medical
Medtronic
Spectranetics
MedStreaming LLC
QualiTest Group
Epic Systems Corporation

 

 

Details

Date:
May 25
Event Category:

Venue

Sheraton Silver Spring
8777 Georgia Ave.
Silver Spring, 20910 United States
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