Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)

Health sciences at UMB and bioengineering at UMCP already have a rich collaborative relationship in both research programs and graduate student programs. Major areas of partnership between the School of Pharmacy at UMB and the Fischell Department of Bioengineering at UMCP include jointly taught graduate courses, joint faculty, and research collaborations.

This relationship is strengthened by the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), a collaborative partnership between the two universities focused on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. Initially funded by a three-year, $3 million grant from the U.S. Food and Drug Administration (FDA), M-CERSI joins researchers from both campuses 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.

Ten workshops have been held on topics ranging from protein aggregation measurement in biotherapeutics to translational pathways for optical drugs and devices for cancer imaging.  One of the most successful workshops was “Predictive Immunogenicity:  Improved Medicines and Better Clinical Outcomes”.

In the past two years, M-CERSI celebrated the growth of the University of Maryland Master of Science in Regulatory Science with 29 new students enrolled in Fall 2018.

 

Maryland Center of Excellence in Regulatory Science and Innovation

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  • Categories: Research