Medical Devices - Patient Engagement in Real World Evidence (RWE)

Wednesday, September 12, 2018
8:00 a.m.-3:45 p.m.
University of Maryland, Baltimore School of Pharmacy, 20 N. Pine Street Baltimore MD
Ann Anonsen
301 405 0285
aanonsen@umd.edu

Mark your calendars for Medical Devices - Patient Engagement in Real Word Evidence (RWE): Lessons Learned & Best Practices. This is a one-day collaborative workshop by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), University of Maryland Center on Drugs and Public Policy (CDPP), and the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH).

 

September 12, 2018

7:30 am - 4:30 pm
Registration opens at 7:30 am

Venue: University of Maryland, School of Pharmacy, Room N103, 20 N. Pine Street, Baltimore, MD 21201


Program Chairs:


Fadia T. Shaya, Ph.D., M.P.H. and Frank B. Palumbo, Ph.D., J.D.

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


Gregory Pappas, M.D., Ph.D., and Lisa Miller, Ph.D.

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

For More Information:

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

Meeting Objectives: 

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), in Coordinated Registry Networks (CRN) and in other community-based activities relevant to the development the use of RWE by the FDA.

 

Meeting Outcomes/Deliverables: 

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.

Registration:

To register, please visit the main event website and follow the instructions provided. The cost to register for this event is determined by participant type. 

If you have any additional questions about how to pay the registration fee, please email fshaya@rx.umaryland.edu.

For more information, contact Lisa Miller, (240) 402-6378, Lisa.Miller@fda.hhs.gov.

 

About the Organizer:

A collaborative partnership between the University of Maryland and 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.

 

Audience: Public 

 

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