M-CERSI EVENTS

Event Information

Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices Workshop
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
For More Information:
Ann Anonsen
301 405 0285
aanonsen@umd.edu
http://www.pharmacy.umaryland.edu/centers/cersievents/device-engagement/

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


 

September 12, 2018

8:30 am-4:30 pm with 7:30 Registration

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


Program Chairs:


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

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


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

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 on this website.

http://www.pharmacy.umaryland.edu/centers/cersievents/device-engagement/

  

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)disclaimer icon, in Coordinated Registry Networks (CRN) and 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

 

Registration:

To register for the public workshop and view the agenda, visit the following website: M-CERSI Events. 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:

Category

Cost

UMB and UMCP Faculty, Staff, and Students

$0

Federal Government Employees

$0

M-CERSI Consortia Members

$0

Other Attendees

$100

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.

 

This Event is For: Public

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