We propose the 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 FDA. M-CERSI leverages the engineering, device, and technologies strengths in College Park with the biomedical and health outcomes strengths in Baltimore.
Five Specific Aims are: 1. Establish Core Program Support and Management Plan to Ensure Success; 2. Grow regulatory science training/educational programs; 3. Build Collaborative Interactions to Foster Regulatory Science Communications Including Scientific Exchanges, Workshops and Seminars; 4. Create New Opportunities for Collaborative Regulatory Science Research; and 5. Create Opportunities to Leverage FDA Funds in Support of CERSI Activities. Pilot research projects are proposed that align UM research strengths with six FDA Regulatory Science Initiatives: o Modernize toxicology to enhance product safety o Support new approaches to improve product manufacturing and quality o Ensure FDA readiness to evaluate innovative emerging technologies o Harness diverse data through information sciences to improve health outcomes o Strengthen social and behavioral science to help consumers and professionals make informed decisions about FDA regulated products o Strengthening the global product safety net In addition to their alignment with FDA-wide priority areas, the pilot projects and other M-CERSI activities align well with priority areas specifically noted by CDER, CBER, CDRH, the OMH, OHI, and OWH. 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

We propose continuation of M-CERSI that fosters scientific exchange, education and training, as well as FDA- oriented research, all focused on regulatory science. The Center is organized into six Specific Aims: Establish Core Program Support and Management Plan to Ensure Success; Grow regulatory science training/educational programs; Build Collaborative Interactions to Foster Regulatory Science Communications Including Scientific Exchanges, Workshops and Seminars; Create New Opportunities for Collaborative Regulatory Science Research; Create Opportunities to Leverage FDA Funds in Support of CERSI Activities. Each aim builds a base for interactions between the University of Maryland and the FDA with the objective being to promote the science that underpins FDA regulatory practice.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD005946-02
Application #
9352280
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2016-09-15
Project End
2018-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
2
Fiscal Year
2017
Total Cost
Indirect Cost
Name
University of Maryland College Park
Department
Biomedical Engineering
Type
Biomed Engr/Col Engr/Engr Sta
DUNS #
790934285
City
College Park
State
MD
Country
United States
Zip Code
20742
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