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.
| Time | Activity |
|---|---|
| 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)
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. |
| 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 |