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Building a Common Risk Evaluation and Mitigation Strategies (REMS) Platform

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Tuesday, June 07, 2016
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8:30 am - 12:15 pm
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Mark McClellan, MD, PhD

The Duke-Margolis Center for Health Policy invites you to attend a public workshop entitled, "Building a Common REMS Platform," which will take place on June 7th, 2016, at Hotel Monaco located at 700 F Street NW, Washington, DC 20004.

The U.S. Food and Drug Administration (FDA) has been working over the last several years on a number of projects to standardize and integrate Risk Evaluation and Mitigation Strategies (REMS) into the health care system. On October 5th, 2015 the Agency announced its latest initiative- the "Common REMS Platform."

In support of next steps in this effort, and under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy is hosting a half-day public event, the purpose of which is to: 1) present FDA's vision for a common REMS platform and obtain feedback on those aspects of the platform that are ready for further development, 2) identify existing data standards and partnerships that may be leveraged in order facilitate the development and broader uptake of REMS common data standards, and 3) explore innovative new tools and systems that may be developed under the common REMS platform.

Please register for the event in-person or via webcast.