A schedule of events for Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness is provided below for the convenience of workshop participants.

This one-day workshop scheduled for Thursday, March 24, 2016, will be held at the University of Maryland School of Pharmacy in Baltimore, Md. It is open to the public. Download a printable version of the workshop agenda here.

TimeActivity
7:30-8:30 a.m. Registration and Breakfast
8:30-8:35 a.m. Welcome
Natalie D. Eddington, PhD, FCP, FAAPS
Dean and Professor
Executive Director of University Regional Partnerships
University of Maryland School of Pharmacy
8:35-8:40 a.m. Introductions
Fadia Tohme-Shaya, MPH, PhD
Professor and Vice Chair for Academic Affairs
Associate Director, Center on Drugs and Public Policy
Department of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
8:40-9:00 a.m. Keynote: FDA Perspective on a National Medical Device Evaluation System
Jeffrey Shuren, MD, JD
Director, Center for Devices and Radiological Health
Food and Drug Administration
9:00-10:00 a.m. Session 1: Harnessing the Digital Revolution for Medical Device Evaluation
Moderator: Gregory Pappas, MD, PhD, Associate Director, National Device Evaluation, CDRH, FDA

Building the National Evaluation System for Medical Devices (NESMD): Work of the Planning Board
Gregory Daniel, PhD, MPH
Deputy Director, Duke-Margolis Center for Health Policy
Duke University

Tools and Methods for Building the NESMD in a New Era – The Role of MDEpiNet
J. Matthew Brennan, MD, MPH
Co-Director, STS Analytical Center
Duke Clinical Research Institute
Duke University

Unique Device Identification: Building Block for the National Evaluation System
Terrie Reed, MS
Senior Advisor for UDI Adoption
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration

Questions
10:00-10:15 a.m. Break
10:15-12:00 p.m. Session 2: Foundations for the National Evaluation System: Where Are We Today?
Moderator: Francis B. Palumbo, PhD, JD, Professor and Executive Director, Center on Drugs and Public Policy, University of Maryland School of Pharmacy

Building Coordinated Registry Networks : A Core Strategy to Build the National System
Art Sedrakyan, MD, PhD
Professor of Healthcare Policy and Research
Professor of Healthcare Policy and Research in Surgery
Weill Cornell Medical College

Discussant: The Case for Orthopedics
Andrew N. Pollak, MD
Chair, Department of Orthopaedics
University of Maryland School of Medicine

Big Data Analytics: Statistical Tools for Utilizing the NESMD
Nelson Lu, PhD
Mathematical Statistician
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration

Discussant: Analyzing Device Risk Using Textual Databases
Monifa Vaughn-Cooke, PhD
Assistant Professor, Department of Mechanical Engineering
University of Maryland, College Park

Using Real-World Evidence for Regulatory Decisions and Practice
Danica Marinac-Dabic, MD, PhD, MMSc
Director, Division of Epidemiology
Center for Devices and Radiological Health
Food and Drug Administration

Discussant: The Case for Interventional Cardiology Devices
Anuj Gupta, MD, FACC, FSCAI
Director, Cath Lab
Department of Medicine
University of Maryland School of Medicine
12:00-1:00 p.m. Lunch
12:00-4:15 p.m. Scientific Information Tables

Epidemiology Regulatory Science Program/ MDEpiNet Public Private Partnership, CDRH, FDA
Benjamin Eloff, PhD; Marta Steliac, MS; and Danica Marinac-Dabic, MD, PhD, MMSc
Division of Epidemiology
CDRH, FDA

Unique Device Identifier (UDI)/MedSun, CDRH, FDA
Linda Sigg, MS, Associate Director for Informatics
Terrie Reed, MS, Senior Advisor for UDI Adoption
Jill Marion, MS, MBA, PMP, Director, Medical Product Safety Network (MedSun)
CDRH, FDA

National Library of Medicine (NLM)
Steven Emrick, Head, Terminology Quality and User Services
Patrick McLaughlin, Support Lead, RxNorm, DailyMed, and AccessGUDID
Josh Temple, Applications Developer, AccessGUDID
NLM, NIH

PCORnet
W. Schuyler Jones, MD
Duke University School of Medicine

University of Maryland School of Pharmacy
Colleen Day, Graduate Program Coordinator
Pharmaceutical Health Services Research
Kristina San Juan, Graduate Program Coordinator
Pharmaceutical Sciences
University of Maryland School of Pharmacy

NIH Health Care Systems Research Collaboratory Program
Wendy Weber, ND, PhD, MPH
Division of Extramural Research
National Institutes of Health
1:00-3:00 p.m. Session 3: Nodes in the Network: Making the Learning Health Care System Real
Moderator: Fadia Tohme-Shaya, PhD, MPH, Professor and Vice Chair for Academic Affairs, Associate Director, Center on Drugs and Public Policy, University of Maryland School of Pharmacy

Presentations:

Sentinel
Nandini Selvam, PhD, MPH
Senior Director, Government and Academic Research
HealthCore

PCORnet
W. Schuyler Jones, MD
Assistant Professor of Medicine
Duke University School of Medicine

MDEpiNet
Danica Marinac-Dabic, MD, PhD, MMSc
Director, Division of Epidemiology
Center for Devices and Radiological Health
Food and Drug Administration

NIH Health Care Systems Research Collaboratory Program
Wendy Weber, ND, PhD, MPH
Chief, Clinical Research in Complementary and Integrative Health Branch
Division of Extramural Research
National Institutes of Health

National Library of Medicine (NLM)
Steven Emrick, Head, Terminology Quality and User Services

NESMD
Gregory Pappas, MD, PhD
Associate Director, National Device Evaluation
CDRH, FDA

Patient Stakeholder

Panel Discussion with Dr. Fadia Tohme-Shaya and Session 3 Presenters: How Can Nodes in the Network Bring Together Their Real-World Evidence to Promote the Learning Health Care System and Improve Medical Device Safety and Effectiveness?
3:00-3:15 p.m. Break
3:15-4:15 p.m. Session 4: Parallel Discussions (Choose Either Session A OR Session B)

Session A (Second Floor, Room S201)
Panel: MDEpiNet Public Private Partnership for Building a National Evaluation System Using Real-World Evidence

Moderator: Benjamin Eloff, PhD, Division of Epidemiology, CDRH, FDA

MDEpiNet is a Public Private Partnership (PPP) that brings together leadership, expertise, and resources to build a national medical device evaluation system by improving and integrating real-world data infrastructure, developing appropriate methodologies, and conducting relevant studies.

The MDEpiNet PPP is composed of over 100 national and international organizations including FDA and world-leading academic institutions, national and international patient registries, healthcare organizations, medical device industry partners and patient and consumer groups. MDEpiNet was initially stood up in 2010 and supported by a series of FDA grants.

In 2014, MDEpiNet evolved into a true PPP with a Methodology Center at Harvard University, a Science and Infrastructure Center at Weill Cornell Medical College, and a Coordinating Center at Duke University. In this session participants will learn about the components of the MDEpiNet PPP, as well as potential opportunities for getting involved.

Session B (Main Auditorium)
Roundtable: Unique Device Identification

Roundtable Facilitators:

  • Linda Sigg, Associate Director for Informatics, CDRH, FDA
  • Terrie Reed, MS, Senior Advisor for UDI Adoption, CDRH, FDA
  • Jill Marion, MS, MBA, PMP, Director, Medical Product Safety Network (MedSun),CDRH, FDA
  • Mike Schiller, Senior Director of Supply Chain, Association of the Healthcare Resource and Materials Management (AHRMM)

Adoption of a structured device identification system like UDI is expected to produce significant benefits to patient care, device safety, and healthcare efficiencies. Since realizing the value of UDI will require changes to healthcare technology infrastructure and process, successful adoption necessitates a commitment to share knowledge and develop best practices across all stakeholder groups affected by the inclusion of UDI in health information.

This session will be used to provide more details about this game changing identification system and allow participants to share information about their own UDI planning and adoption efforts. Participants will be invited to share their perspectives on a new Learning UDI Community (LUC) that is being created to support stakeholders from academia, healthcare, government, medical device industry, and patient advocacy groups who are committed to UDI adoption.

4:15-4:30 p.m. Closing Remarks

Wrap-up: Impact and Collaborations
Fadia Tohme-Shaya, PhD, MPH
Professor and Vice Chair for Academic Affairs
Associate Director, Center on Drugs and Public Policy
University of Maryland School of Pharmacy

Next Steps
Gregory Pappas, MD, PhD
Associate Director, National Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
4:30 p.m. Adjourn