DIA 48th Annual Meeting
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Patient Advocacy in Medical Product Development: The Evolving Relationship Between FDA and Its Patient Stakeholders
Track : Track 08: Regulatory Affairs and Submissions
Program Code: 312
Date: Wednesday, June 27, 2012
Time: 8:00 AM to 9:30 AM  EST
CHAIR :
 James Valentine, FDA, United States
PRESENTER (S):
Patrick Frey, FDA, United States
 Marc Boutin, National Health Council, United States
Marcia Horn, International Cancer Advocacy Network, United States
Description
This session will explore the role of patient advocates in FDA decision-making. FDA will describe its patient advocacy programs and the value they have added. A patient representative will discuss their interactions and experience with the agency.

Learning Objectives:
Describe the mechanisms FDA utilizes to engage patient advocates
State the value of incorporating the patient perspective into medical product development decision-making
Identify best practices that could be used to establish a patient advocacy program at their organization.