Project Summary: 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 include: 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.