Medical Devices

Public Workshop - Medical Devices - Patient Engagement in Real-World Evidence (RWE): Lessons Learned and Best Practices Workshop Announcement, September 12, 2018

The FDA's Center for Devices and Radiological Health (CDRH) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and Center on Drugs and Public Policy (CDPP) is announcing a 1-day workshop, “Medical Devices - Patient Engagement in Real-World Evidence (RWE): Lessons Learned and Best Practices.”

The purpose of this workshop is to gather lessons learned and best practices for patient engagement in evidence generation (planning, collection of data and information, analysis, and dissemination). The workshop will provide a discussion forum for patients and patient groups on how they are engaged with real-world evidence generation for medical device or device and drug combination evaluation. Lessons learned will be drawn from work going on in the National Patient Centered Clinical Research Network (PCORnet)disclaimer icon, in Coordinated Registry Networks (CRN) and other community-based activities relevant to the development the use of RWE by the FDA.

The public workshop will be held on:

Date: September 12, 2018
Time: 8:30 a.m. - 4:30 p.m., Registration Begins at 7:30 a.m.


The public workshop will be held at University of Maryland, School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201.


To register for the public workshop and view the agenda, visit the following website: M-CERSI Eventsdisclaimer icon. Registrants will receive confirmation when they have been accepted. There is on-site registration.

There is a registration fee to attend this public workshop in person. Seats are limited and registration will be on a first-come, first-served basis. The cost to attend in person is as follows:



UMB and UMCP Faculty, Staff, and Students


Federal Government Employees


M-CERSI Consortia Members


Other Attendees


More Information: Contact Lisa Miller, (240) 402-6378,

Page Last Updated: 09/12/2018
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