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Fri, Mar 22


University of Maryland School of Pharmac

Patient Engagement and NEST: Lessons Learned and Best Practices

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Time & Location

Mar 22, 2019, 7:00 AM

University of Maryland School of Pharmac, 20 N Pine St, Baltimore, MD 21201, USA

About the Event


Program Chairs:

Fadia T. Shaya, PhD, MPH and Frank B. Palumbo, PhD, JD

University of Maryland Baltimore Center on Drugs and Public Policy, School of Pharmacy, Pharmaceutical Health Services Department

Gregory Pappas, MD, PhD, and Lisa Miller, PhD

Center for Devices and Radiological Health (CDRH) Food and Drug Administration

Meeting Objectives:  This meeting will engage a variety of patient and patient groups related to the device ecosystem.  An objective of NEST is to fully engage patients in its development and function in all aspects.  The workshop will gather lessons learned and best practices for patient engagement in evidence generation (planning, collection of data and information, analysis, and dissemination).  The workshop should stimulate discussion on the best practices and lessons learned for NEST to more fully engage patients

Meeting Outcomes/deliverables:  The workshop should document, as presented by the speakers, existing best practices and lessons learned of how patients are engaged with real world evidence generation for medical device or device and drug combination evaluation.  The workshop speakers should identify evidence gaps for future investigation.  The workshop will also document the best practices and lessons learned for patient engagement in the production and use of real world evidence (RWE) that will facilitate future work in this area.    Lessons learned and best practices will be drawn together into a proceedings document from this workshop.

TimeEvent Description/Agenda Notes7:30-8:30Registration, Coffee and light breakfast8:30am-12:30pm

Morning sessions 

8:30-9:30Session 1 – Framing the Challenge

  1. Welcome – Dr. Natalie Eddington, Dean, UMB School of Pharmacy or delegate
  2. Remarks – Dr. William Maisel, M.D., M.P.H., Deputy Director for Science, CDRH
  3. Patients and patient groups perspective
  4. From clinical data to information: translational research  – Dr. Fadia Shaya, UMB School of Pharmacy, Center on Drugs and Public Policy

9:30-10:00Session 2 – Keynote10:00-10:30Coffee Break10:30-11:30Session 3 – Building the Infrastructure

  1. The policy framework: transparency – Dr. Frank Palumbo, UMB School of Pharmacy, Center on Drugs and Public Policy
  2. Electronic Clinical Data Capture from Electronic Health Records for Patient Safety Monitoring and Surveillance – Dr. Christopher Chute, Johns Hopkins
  3. Overview of NEST – Dr. Rachael Fleurence
  4. CRNs and patient engagement – Dr. Art Sedrakyan, Weill Cornell Medicine

11:30-12:30Session 4 – Best Practices

  1. Case Study #1   PCORI PPRN – Dr. Claudia Grossman, PCORI
  2. Case Study #2   Vascular Quality Initiative
  3. Case Study #3   PATIENTS program – Dr. C. Daniel Mullins, UMB School of Pharmacy

12:30-1:30LunchTable exhibits, invitations will be sent to patient groups offering them a table.1:30pm-3:00pm

Afternoon concurrent breakout sessions

Small groups will work in parallel, to bring together best practices and lessons learned for patient engagement to develop and use of RWE in NEST.

Breakout session 1: CardiologyModerator: Ms. Kathleen Hewitt, ACC (accepted) Breakout session 2: OrthopedicsModerator: TBABreakout session 3: Women’s healthModerator: Dr. Danica Marinac-Dabic, FDA/CDRH 3:00-4:30Closing session

  1. Reconvene in auditorium for report from each group.  Meeting scribes/rapporteurs will note overlapping points and report large posters.
  2. General summary, overlapping / specific points noted
    1. Next steps– Dr. F. Shaya (UMB) and Dr. G. Pappas (FDA/CDRH)
  3. Closing remarks – Dr. W. Maisel (FDA/CDRH)

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