Public Workshop: A Framework for Regulatory Use of Real-World Evidence

September 13, 2017 -
9:00 am to 4:00 pm

1777 F Street NW
Washington, DC 20006

Description

PLEASE NOTE:  In-person registration for this event is now CLOSED due to venue capacity. You may still register for the webcast by clicking on the Register Now button.

Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and evidence (RWE) in drug development and regulatory decision-making. Topics will include an update on FDA’s implementation of the 21st Century Cures Act’s provisions related to RWE and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve the data development activities, study designs, and analytical methods used to create robust RWE.