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.

TimeActivity
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

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

Overview of NEST
Rachael Fleurence, PhD
Executive Director
National Evaluation System for Health Technology Coordinating Center

Patients and Patient Groups Perspective
Terrie Cowley
President and Co-Founder
The TMJ Association, Ltd.
9:40-10:15 a.m. Session 2: Keynote

Key Opportunities and Introduction of Keynote Speaker
Fadia T. Shaya, MPH, PhD
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
Global Head of Patient Solutions
Sanofi
10:15-10:30 a.m. Coffee Break
10:30-11:30 a.m. Session 3: Building the Infrastructure

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 Infrastructure, ICTR at UMB
Stephen N. Davis, MBBS
Chairman, Department of Medicine
Vice President, Clinical Translational Science
University of Maryland School of Medicine

Clinical and Translational Research for Medical Devices: Bioinformatics in the Context of ICTR and Patient Engagement
Fadia T. Shaya, MPH, PhD
Professor, Department of Pharmaceutical Health Services Research
Associate Director, Center on Drugs and Public Policy
University of Maryland School of Pharmacy

Coordinated Research Networks (CRNs) and Patient-Centered Research
TBD
11:30 a.m. – 12:30 p.m. Session 4: Case Studies

Case Study #1: TBD

Case Study #2: Vascular Quality Initiative
Philip Goodney, MD, MS
Associate Professor and Vice Chair of Research, Department of Surgery
Director, Center for the Evaluation of Surgical Care
Co-Director, VA Outcomes Group
The Dartmouth Institute

Case Study #3: The RADCOMP Consortium Experience: Patient Engagement in a Large Pragmatic Randomized Clinical Trial
C. Daniel Mullins, PhD
Professor and Chair, Department of Pharmaceutical Health Services Research
Director, PATIENTS Program
University of Maryland School of Pharmacy

Joey Mattingly, PharmD, MBA
Assistant Professor
Department of Pharmacy Practice and Science
University of Maryland School of Pharmacy
12:30-1:30 p.m. Lunch
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 in NEST
  • Breakout Session 1
    Moderator: Kathleen Hewitt, MSN, RN, CPHQ, Associate Vice President for the National Cardiovascular Data Registry
  • Breakout Session 2
    Moderator: Nneka Onwudiwe, PharmD, PhD, MBA, PRO/PE Regulatory Review Officer, FDA
  • Breakout Session 3
    Moderator: Danica Marinac-Dabic, MD, PhD, Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA
3:00-4:30 p.m. Closing Session

Panel Discussion
Moderators from breakout sessions will not overlapping points and engage in a panel discussion.

Closing Remarks
Jeffrey E. Shuren, MD, JD
Director
Center for Devices and Radiological Health
Food and Drug Administration