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

Drug Efficacy & Obesity

The FDA and M-CERSI hosted a workshop on Wednesday, Nov. 9, 2022 – Bridging Drug Efficacy and Safety to the Obese: Considerations and Scientific Approaches. Workshop presentation files and video links are now available.

Learn More

Pharmaceutical Manufacturing

This study, published by Dr. Clifford Rossi, presents an economic analysis of the effects of a manufacturing quality rating on the pharmaceutical industry.

View the Report

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.

On May 16th and 17th, the M-CERSI and FDA hosted a "Pharmacokinetic Evaluation in Pregnancy" workshop

Learn More

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.

View Event Archives

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.

Learn More

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.”

Learn More

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.

Learn More