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.
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.
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