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Wed, Sep 14


FDA White Oak Bldg 32

RAPID Working Group Meeting

Registration is Closed
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Time & Location

Sep 14, 2016, 7:00 AM

FDA White Oak Bldg 32, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

About the Event


Event Recordings

Part 1 (2 hr 25 min)

Part 2 (1 hr 17 min)

Part 3 (2 hr 59 min)

Hot Topics:

  • 1st Public Release of the Phase I RAPID Core Data Set for PAD Device Evaluation
  • Aligning RAPID with National Evaluation System for Health Technology (NEST), Sentinel, HSPC, and other ongoing initiatives
  • International alignment leveraging RAPID core data elements
  • RAPID implementation and clinical trial opportunities for Peripheral Devices

7:30-8:00 AMRegistration and Refreshments8:00–8:30 AMWelcome & Introductions Danica Marinac-Dabic, FDA Update on National Evaluation System for Health Technologies (NEST) William Maisel, FDA 

MDepiNet, PASSION, & RAPID in the Context of NEST Mitchell Krucoff, DCRI

8:30-9:10 AM Overview of RAPID Jack Cronenwett, Society for Vascular Surgery (SVS) 

RAPID Phase I Work Product Overviews:

§  Use cases, Flow Diagrams James Tcheng, DCRI

§  GUDID Working Group Summary Terrie Reed, FDA

§  Core Minimum Data Set Schuyler Jones, DCRI

9:10-10:15 AMRAPID towards NEST: Lessons Learned, Common Themes and Potential

Opportunities Terrie Reed, FDA

§  Use of General Patient Descriptors from Sentinel in RAPID Richard Platt, Harvard Pilgrim 

§  Addressing issues impacting Adoption of UDI Joseph Drozda, Mercy Health System 

§  Integrating RAPID Common Data Elements and modeling with the goals of HSPC Stan Huff, Intermountain Healthcare 

Discussion: Lead Discussant Greg Pappas, FDA

10:15-10:30 AMBreak10:30-11:45 AMRAPID Phase II:  Implementation core data elements    

§  Implementing RAPID Core Data Elements–NCDR PVI registry view Thomas Tsai, American College of Cardiology (ACC)/National Cardiovascular Data Registry (NCDR)

§  Implementing RAPID Core Data Elements–VQI PVI registry view Carrie Bosela, SVS VQI

§  MedStreaming EHR Ahmed Saad, MedStreaming

§  PAD Characterization within a health system Schuyler Jones, DCRI 

§  Multidisciplinary PVI Structured Reporting Standards James Tcheng, DCRI

Discussion, Lead Discussants: Donna Buckley, FDA Pablo Morales, FDA

11:45-Noon      Break and Pick-up lunch boxes12:00-1:00 PMPerspectives on Interactions & Implementation (Working LunchLeader: Mitchell Krucoff, DCRI


§  Centers for Medicare and Medicaid Services Daniel Canos, Centers for Medicare and Medicaid Services (CMS)

§  BUILD Joseph Drozda, Mercy Health System

§  Health Systems Platform Consortium Stan Huff, Intermountain Healthcare

§  The Pew Charitable Trust  Anqi Lu, The Pew Charitable Trust 

§  FDA Misti Malone, FDA

§  Sentinel Richard Platt, Harvard Pilgrim

§  Industry Melanie Raska, Boston Scientific  

Discussion, Lead Discussants  Greg Pappas, FDA Julia Skapik, ONC

1:00-2:45 PMMulti-Stakeholder Collaborative Approach to RAPID Phase III: Thinking Forward! 

Summary of RAPID Proposals Robert Thatcher, 4C Medical Technologies

Lessons learned from SAFE-PCI Britt Barham, DCRI

Lessons learned from VQI Dissection Study Jack Cronenwett, SVS 


Industry Partners Brian Fortier, Aorta Medical Aaron Lottes, Cook Medical Dedra Markovich, Cook Medical Melanie Raska, Boston Scientific Justin Recknor, WL Gore Josh Smale, Bard Peripheral Vascular 

Federal Partners Misti Malone, FDA Danica Marinac-Dabic, FDA Jyme Schafer, CMS Karen Ulisney, FDA

 Discussion2:45-3:00 PMBreak3:00–3:45 PMInternational Opportunities and Methodological Considerations

IMDRF opportunities: Update on Registry Essential Principles (Slides coming soon) Danica Marinac-Dabic, FDA

‘How will we do this?’ or ‘Now What?’ – Methodological Considerations moving forward Sharon-Lise Normand, Harvard Medical School

Discussion, Lead Discussant Art Sedrakyan, Weill Cornell Medical College

3:45-4:00 PMNEST & Next steps Pablo Morales, FDA Jack Cronenwett, SVS Robert Thatcher, 4C Medical Technologies Danica Marinac-Dabic, FDA

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