Center of Excellence in Regulatory Science and Innovation (M-CERSI)
At the Heart of Biotech
The University of Maryland Center of Excellence in Regulatory Science and Innovation is located within an hour’s drive from many of the nation’s top bioscience research forces—including the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the University of Maryland School of Medicine.
September 1-2 M-CERSI Workshop
"Advancing the Development of Pediatric Therapeutics (ADEPT 7)" is open to the public and slated for September 1-2, 2021. Attendees will discuss methodological considerations and cases studies pertaining to new FDA guidelines. The session will allow for an open dialogue between regulators, academic researchers, and drug developers.
Developing New TBI Biomarkers
The research team spearheading the M-CERSI-funded project “Development of Diagnostic Biomarkers for Determination of Traumatic Brain Injury” is working to enable the characterization of two specific lipid molecules as diagnostic biomarkers of traumatic brain injury.
Fetal Pharmacology Workshop
The "Fetal Pharmacology and Therapeutics" FDA/M-CERSI workshop will take place on October 21-22, 2021. Attendees will discuss recent advancements in fetal pharmacology and therapeutics, and how they pertain to pediatric drug development.
Download presentations, audio, and video from past M-CERSI workshops, such as the Predictive Immunogenicity for Better Clinical Outcomes workshop, or the Pediatric Inflammatory Bowel Disease (IBD) workshop.
annual M-CERSI talent competitions celebrated since 2013
Each year, M-CERSI hosts the "America's Got Regulatory Science Talent" competition, through which students are invited to meet with FDA staff to discuss their project proposals.
total participants in M-CERSI monthly lectures
M-CERSI hosts monthly lectures on topics ranging from "Patient Understanding of Medical Products" to “The Immune Properties of Natural and Synthetic DNA.”
participants in M-CERSI Exchange Award Conferences
Science Exchange conferences tackle topics ranging from Drug Development in Pediatric Heart Failure to Building the National Evaluation System for Medical Devices.
News & Events
Ninth Annual M-CERSI Regulatory Science Competition Goes Virtual
Nine teams presented their innovations to a panel of three FDA judges via WebEx on Friday, January 15, 2021.