CERSI

SOP’s Mattingly Awarded $2.2 Million Grant to Investigate Bulk Drug Substances for Compounding

December 4, 2018

Grant from the U.S. Food and Drug Administration will span three years and include evaluations for more than 200 nominated substances.

M-CERSI Cooperative Agreement Grant Renewed by Food and Drug Administration

October 3, 2018

Latest renewal allows for up to $5 million per year over five years, and will help M-CERSI further advance its mission to promote the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

Ensuring Prescription Drug Quality for All Patients

May 24, 2018

Dr. James Polli’s extraordinary accomplishments in the field of regulatory science make him a UMB Champion of Excellence.

Annual Competition Spotlights Student Innovation in Regulatory Science

February 12, 2018

Third-year student pharmacists take the gold for their proposal to develop a transparent tracking system for emerging CAR T-cell gene therapies.

CERSI Conference Shows Quality is Key in Patient-Centric Drug Development

June 27, 2017

Researchers discuss how to leverage a variety of dissolution and translational modeling strategies to ensure patients continue to have access to safe, effective medications.

Talent Competition Highlights Student Innovation in Regulatory Science

February 3, 2017

First-ever undergraduate competitor takes the gold for project to develop a universal labeling system for hazardous drugs.

CERSI Conference Explores Methods to Measure Protein Aggregation

January 12, 2017

Researchers from academia, government, and industry examine both established and emerging techniques to detect protein aggregation in biologic drug products.

CERSI Conference Highlights Need for National Medical Device Evaluation System

April 20, 2016

Researchers across academia, government, and industry explore how real world evidence can be harnessed to create a national evaluation system and improve the safety and effectiveness of medical devices.

SOP Talent Competition Brings Student Innovation to the Forefront

February 19, 2016

Fourth annual M-CERSI “America’s Got Regulatory Science Talent” competition awards third-year student pharmacists first prize for novel solution to improve FDA’s post-marketing surveillance program.

CERSI Symposium Highlights Use of Biomarkers in Drug Development

August 28, 2015

More than 500 researchers from academia, government, and industry gather to gain perspective on biomarker development and the application of biomarkers in preclinical and clinical research.

Talent Competition Highlights Student Innovation in Regulatory Science

February 11, 2015

Winners of student regulatory science talent competition propose mobile application to help improve patient medication knowledge.

CERSI Conference Spotlights New Applications for Top-Down Mass Spectrometry

June 30, 2014

Researchers from academia, government, and industry examine benefits and new methods associated with emerging technology.