We propose a 5-year renewal of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), a consortia of the two leading sister campuses within the University System of Maryland, and the Food and Drug Administration (FDA). M-CERSI leverages the biomedical and health outcomes strengths in Baltimore with the engineering and technologies strengths in College Park.
Aims i nclude: Establish core program infrastructure and management plan to ensure success; Conduct regulatory science research; and Provide regulatory science training/educational programs. Proposed research projects align with FDA high priority topics, develop and evaluate methods to improve quality and safety, and/or develop methods and tools to improve and streamline clinical and post-market evaluation. Research is collaborative with FDA scientists and employs a vast array of research capabilities at UM. Research is amplified by a robust training/educational program, which includes lectures, workshops, scholars program, and the America's Got Regulatory Science Talent Competition. The sum of these activities describe a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of regulatory sciences and practices, and generates new knowledge in support of the FDA's fundamental mission ? to promote and protect the public health.

Public Health Relevance

Statement We propose continuation of M-CERSI that fosters FDA-oriented research, as well as training/educational programs. The Center's mission is to foster the development of regulatory science ? the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Activities leverage the close geographic proximity between University of Maryland and FDA's main campus.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01FD005946-03S1
Application #
9858464
Study Section
Special Emphasis Panel (ZFD1)
Program Officer
Blumkemelor, Donna
Project Start
2016-09-15
Project End
2023-08-31
Budget Start
2018-09-01
Budget End
2019-08-31
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Maryland Baltimore
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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