Welcome

Phantom Design and Fabrication.
Phantom Characterization.
Hyperspectral Imaging of Phantoms.
Analysis of the Imaging Results Provides Assessment of the Imaging System.
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The University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI) is funded by an initial $1 million grant from the U.S. Food and Drug Administration (FDA). In a new FDA effort, the center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

The center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland in Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Through the M-CERSI, researchers, regulators and industry professionals can learn from one other in the effort to develop regulatory science practices that promote innovation in medical devices and pharmaceuticals, while also addressing critical safety concerns.

This website highlights regulatory science activities at the center and coalesces center research projects into an information-rich resource base. The site will be populated with articles and opinion statements by M-CERSI researchers.

News Headlines

September 1, 2014 Submission Deadline More»

Regulatory Science Competition Winners Present Concepts to FDA More»

UMB President Highlights MPower, M-CERSI More»

Bentley Receives ACS BIOT’s Marvin J. Johnson Award More»


Upcoming Events

Predicting Cancer-specific Vulnerability via Data-driven Detection of Synthetic Lethality
October 15, 2014, 10:00 a.m.-11:00 a.m. More»

Davis Stephen Pisetsky, M.D.
November 12, 2014, 12:30 p.m.-1:30 p.m. More»

Building a Translational Safety Strategy
November 18, 2014, 2:00 p.m.-3:00 p.m. More»

Clinical Trials Design: Bayesian Approaches and Simulations
January 13, 2015, 2:00 p.m.-3:00 p.m. More»


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