Mark your calendars for Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices Workshop.

This one-day workshop will be hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), the Center on Drugs and Public Policy (CDPP) at the University of Maryland School of Pharmacy, and the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA).

Important Event Details
Date: Wednesday, Sept. 12, 2018
Time: 7:30 a.m. - 4:30 p.m.
Location: University of Maryland School of Pharmacy
20 N. Pine Street
Baltimore, MD 21201
Program Chairs: Fadia T. Shaya, PhD, MPH, and Francis B. Palumbo, PhD, JD
Center on Drugs and Public Policy
Department of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy

Gregory Pappas, MD, PhD, and Lisa Miller, PhD
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration
Meeting Objective: This meeting will engage a variety of patients 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 (e.g., 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/Deliverable: The workshop will 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 will 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.

About the Organizers:

A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.
Official Logo for the Center for Drugs and Public Policy at the University of Maryland School of Pharmacy Through its innovative research and educational programming, the Center on Drugs and Public Policy (CDPP) at the University of Maryland School of Pharmacy examines the dynamic connections between theory and practice in the health care arena, assessing the impact on regulation, policy, industry practices, and health care treatment standards.

For More Information:

More information about this event, including how to register, an agenda, and parking and accommodations, is available on this website.