The FDA is announcing the following public workshop entitled ‘‘Developing a Framework for Regulatory Use of Real-World Evidence.’’ Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making. Topics will include an update on FDA’s activities to address the use of RWE in regulatory decisions and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve data development activities, study designs, and analytical methods used to create robust RWE.
The public workshop will be held on September 13, 2017, from 9 AM to 4:30 PM Eastern Time at the Conference Center at 1777 F Street NW., Washington, DC 20006. There will also be a live webcast for those unable to attend the meeting in person.
For additional information, please refer to the following Web site: https://healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence
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