A tentative schedule of events for Medical Devices - Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices is provided below for the convenience of conference attendees.
This one-day workshop will be held on Wednesday, Sept. 12, 2018, at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.
- Download a printer-friendly version of the agenda here.
- Download a printer-friendly version of the speakers' biosketches here.
| Time | Activity |
|---|---|
| 7:30-8:30 a.m. | Registration, Coffee, and Light Breakfast |
| 8:30 a.m. - 12:30 p.m. | Morning Sessions |
| 8:30-9:40 a.m. | Session 1: Framing the Challenge Pharmacy Hall, Room N103 Welcoming Remarks Natalie D. Eddington, PhD, FCP, FAAPS Dean and Professor University of Maryland School of Pharmacy Opening Remarks Jeffrey E. Shuren, MD, JD Director Center for Devices and Radiological Health Food and Drug Administration Patients and Patient Groups Perspective Terrie Cowley President and Co-Founder The TMJ Association, Ltd. |
| 9:40-10:15 a.m. | Session 2: Keynote Pharmacy Hall, Room N103 Key Opportunities and Introduction of Keynote Speaker Fadia T. Shaya, PhD, MPH Professor, Department of Pharmaceutical Health Services Research Associate Director, Center on Drugs and Public Policy University of Maryland School of Pharmacy Keynote Presentation Anne C. Beal, MD, MPH Associate Director, Center on Drugs and Public Policy Global Head of Patient Solutions Sanofi |
| 10:15-10:30 a.m. | Coffee Break Pharmacy Hall, Balch Gallery |
| 10:30-11:30 a.m. | Session 3: Building the Infrastructure Pharmacy Hall, Room N103 Clinical and Translational Research Infrastructure, ICTR at UMB Stephen N. Davis, MBBS, FRCP, FACE, MACP Dr. Theodore E. Woodward Chair in Medicine Director, General Clinical Research Center Director, Clinical and Translational Sciences Institute University of Maryland School of Medicine Transparency in the Infrastructure Francis B. Palumbo, PhD, JD Professor, Department of Pharmaceutical Health Services Research Executive Director, Center on Drugs and Public Policy University of Maryland School of Pharmacy Clinical and Translational Research for Medical Devices: Bioinformatics in the Context of ICTR and Patient Engagement Fadia T. Shaya, PhD, MPH Professor and Vice Chair, Department of Pharmaceutical Health Services Research Associate Director, Center on Drugs and Public Policy Institute for Clinical and Translational Research Bioinformatics University of Maryland School of Pharmacy Overview of NEST Rachel R. Rath, MPH Deputy Director, NEST Coordinating Center Medical Device Innovation Consortium |
| 11:30 a.m. – 12:30 p.m. | Session 4: Case Studies Pharmacy Hall, Room N103 Case Study #1: Women's Health Technologies Coordinated Network (CRN) and Beyond -- Engaging and Empowering our Patient Partners Courtney E. Baird, MS Research Data Analyst Division of Comparative Effectiveness and Outcomes Research MDEpiNet, Weill Cornell Medicine Case Study #2: The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) -- What Do We See Next? Philip Goodney, MD, MS Surgeon and Health Services Research Center for the Evaluation of Surgical Care, Dartmouth Case Study #3: The RADCOMP Consortium Experience: Patient Engagement in a Large Pragmatic Randomized Clinical Trial Joey Mattingly, PharmD, MBA Assistant Professor, Department of Pharmacy Practice and Science Director of Operations, PATIENTS Program University of Maryland School of Pharmacy C. Daniel Mullins, PhD Professor and Chair, Department of Pharmaceutical Health Services Research Director, PATIENTS Program University of Maryland School of Pharmacy |
| 12:30-1:30 p.m. | Lunch Pharmacy Hall, Balch Gallery |
| 1:30-2:45 p.m. | Small Group Concurrent Breakout Sessions Small groups will work in parallel to bring together best practices and lessons learned for patient engagement to develop and use real-world evidence.
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| 2:45-3:15 p.m. | Afternoon Refreshments and Snack Break Pharmacy Hall, Balch Gallery |
| 3:15-4:15 p.m. | Closing Session Pharmacy Hall, Room N103 Panel Discussion Moderators from breakout sessions will note overlapping points and engage in a panel discussion. Fadia T. Shaya, PhD, MPH Professor and Vice Chair, Department of Pharmaceutical Health Services Research Associate Director, Center on Drugs and Public Policy Institute for Clinical and Translational Research Bioinformatics University of Maryland School of Pharmacy Danica Marinac-Dabic, MD, PhD, FISPE, MMSc Director, Division of Epidemiology, Office of Surveillance and Biometrics Center for Devices and Radiological Health Food and Drug Administration Closing Remarks Lisa Miller Noel, PhD Senior Fellow, Office of Center Director Center for Devices and Radiological Health Food and Drug Administration |