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

About M-CERSI

M-CERSI is an FDA-sponsored center at the Baltimore and College Park campuses of the University of Maryland, under the coordination of FDA Office of Regulatory Science and Innovation (ORSI). View our introductory presentation to learn more.

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Role of In Vitro Dissolution

From March 11-12, 2025, attend the FDA and M-CERSI workshop titled "Role of In Vitro Dissolution Studies for Predictive Insight into In Vivo Performance" This workshop brings together scientists from regulatory agencies and industry to discuss the role of dissolution testing in identifying and controlling critical bioavailability attributes (CBAs) of solid oral dosage forms.

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Pediatric Formulation

From June 25-26, 2025, attend the "Pediatric Formulation Development" workshop hosted by the FDA and M-CERSI. This workshop brings together the pediatric community members including pharmaceutical scientists and clinical counterparts from diverse functions. The workshop is intended to shed light on the barriers to and opportunities for patient-focused pediatric formulations.

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Past Events

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.

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annual M-CERSI talent competitions celebrated since 2013

America's Got Regulatory Science Talent

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.

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2,664+

total participants in M-CERSI monthly lectures

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.”

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10,297+

participants in M-CERSI Exchange Award Conferences

M-CERSI Science 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.

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