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.
This study, published by Dr. Clifford Rossi, examines the risks and economics associated with investing in continuous (CM) versus conventional batch manufacturing for production of oral solid dosage pharmaceutical (OSD) products in the U.S. and abroad.
October 13-14 M-CERSI Workshop
"Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age" took place on Oct. 13-14, 2021. The workshop included several short talks and provided interactive sessions to address unique aspects of leveraging adult data and provide an overview of innovative trial design.
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
Accepting Applications for NCATS/FDA Fellowship
The FDA is seeking applications for the Translational Science Interagency Postdoctoral Fellowship.