Research

Strategy

The M-CERSI creates new mechanisms for scientific exchange, education and training, as well as regulatory science research. The center brings together diverse thoughts and ideas around emerging technologies and methodologies for regulatory science. The sum of these interwoven activities is a vibrant, cutting edge center that stimulates innovative thought, disseminates understanding of regulatory science and practices, and generates new knowledge in support of the FDA’s fundamental mission -- to promote and protect the public health -- under current priorities and initiatives.

Visiting Scientists

A critical component of center success is establishing, promoting, and facilitating two-way connections between UM and FDA staff. The M-CERSI will invite visiting scientists from the FDA and from industry to engage with the new Center and to engage in scientific exchange. Also, M-CERSI will provide continuing education (CE) training for FDA personnel.

Creating New Opportunities for Collaborative Regulatory Scientific Research

  • Center-Wide Regulatory Science Activities – The M-CERSI will execute in parallel three regulatory science projects reflecting the collective strengths of UM campuses in College Park and in Baltimore. The Scientific Exchange, Research and Training Activities for each project are managed by project leaders.
  • M-CERSI sponsors a small regulatory science research component that is unattached to its projects. Several small Innovation Awards will help build its program in the future.
  • Specific Regulatory Science Activities - M-CERSI focuses on three project areas, each corresponding to an FDA-specified focus. Each major project area includes training and exchange, as well as a research component. Each major project will support at least two graduate students / fellows, who will benefit from FDA advice and guidance.  The Executive Committee, comprised of UM and FDA leadership, will solicit proposals from UM faculty and develop a specific plan for each project area. In this way, priorities can be identified and appropriate investments can be made. Additionally, this will provide a mechanism for project renewal and/or new project development as the Center grows and matures.