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Thu, May 25


Sheraton Silver Spring Hotel

Phase II/III Working Group Meeting

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

Registration is Closed
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Time & Location

May 25, 2017, 7:00 PM

Sheraton Silver Spring Hotel, 8777 Georgia Ave, Silver Spring, MD 20910, USA

About the Event

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


Meeting Recording (Audio Only)

08:00-08:30 Welcome and Updates

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

              Moderator:  James Tcheng, Duke University

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

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

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

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

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

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