Medical Devices - Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices

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

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:	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 other community-based activities relevant to the development the use of RWE by the FDA.
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.
	The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) is responsible for protecting and promoting the public health. The center assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products and provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products it oversees.
	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.