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

Mission: A collaborative partnership between UMB and UMCP focused on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

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Funded by 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.

In 2018, M-CERSI introduced Master of Science in Regulatory Science.

In August 2023, the FDA renewed funding under a new five-year cooperative agreement, making M-CERSI one of only five FDA-funded CERSIs in the country and the oldest. In November 2023, M-CERSI’s Co-Director, James E. Polli, PhD, was named an MPower Professor.


The Latest 

FDA Agreement Provides $50 Million for Regulatory Science

M-CERSI and FDA’s AI workshop highlighting future FDA comment period on AI in drug development