Centers of Excellence in Regulatory Science and Innovation (CERSIs)

Centers of Excellence in Regulatory Science and Innovation (CERSIs) is sponsored by FDA Office of Regulatory Science and Innovation. Supports collaborative research projects between FDA and academic institutions to advance regulatory science and innovation.

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Extramural Regulatory Science – CERSIs ORES manages FDA-wide programs that provide funding to support extramural regulatory science and innovation to address scientific and public health priorities.

The Centers of Excellence in Regulatory Science and Innovation (CERSI) program was established to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory and Emerging Science (ORES), , through collaborative interactions with FDA scientific experts and funding offices.

--> The Centers of Excellence in Regulatory Science and Innovation (CERSI) program was established to foster robust and innovative approaches to advance regulatory science. both individually and synergistically through collaborative interactions between academia, industry, and FDA.

The CERSIs promote innovation in regulatory science predominantly through supporting cutting-edge scientific research that address high-priority regulatory science needs identified within FDA's Regulatory Science Framework . They may also provide regulatory science information sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions.

The current CERSI institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004 . The institutions in the CERSI program received current awards starting September 1, 2023 with a maximum of $50M over 5 years.

CERSI CERSI Establishment Date --> University of Maryland 2012 --> Johns Hopkins University 2014 --> University of California at San Francisco (UCSF) - Stanford University 2014 --> Yale University-Mayo Clinic 2016 --> Research Triangle CERSI 2023 ORSI is pleased to announce several renewal awards and one new award for the CERSI Program.

The institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004 . Renewal awards were made to University of Maryland , Johns Hopkins University , Yale University in joint effort with Mayo Clinic , and University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford) .

A new award was made to the University of North Carolina, Chapel Hill, in a partnership with Duke University. The new Research Triangle CERSI also plans to partner with North Carolina State University and North Carolina Central University, a historically black college and university (HBCU) on research projects and regulatory science information sharing opportunities.

The institutions in the CERSI program received awards starting September 1, 2023 for up to $50M for 5 years. --> For questions regarding CERSI contact FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Letters of intent are due by October 31, 2022 , and applications are due by December 22, 2022 .

--> cersi-team@fda. hhs. gov Research, Scientific Exchanges, and Training A strong in-house contingent of scientific and technical experts proficient in cutting-edge science together with a network of collaborations is key to FDA's capacity to evaluate increasingly complex products and promote innovation that addresses unmet public health needs.

CERSI Steering Committee, Research Priority Areas and Metrics The FDA Steering Committee for the CERSIs provides advice and guidance to FDA's Office of Regulatory Science and Innovation that established the CERSI program and to the CERSI academic institutions to ensure that relevant issues and activities are effectively communicated to FDA leadership and staff.

Through the CERSIs, FDA offers its scientific staff a range of opportunities, including research collaborations and access to regulatory science-related training, workshops, and seminars. These opportunities support FDA staff engagement with the academic and medical communities in areas of mutual interest in regulatory science. FDA has developed Outcomes of Interest for Regulatory Science Research Projects.

Please join us for the CERSI Program Showcase on October 5, 2023. Click the link for more information and to register for virtual attendance . --> CERSI Collaborative Research Projects FDA has developed Outcomes of Interest for Regulatory Science Research Projects .

which will be used to assess the contributions/impact of the CERSI program.

Yale University-Mayo Clinic Office of Regulatory and Emerging Science (ORES) CERSI Regulatory Science Information Sharing Opportunities 2023 CERSI Program Showcase Workshops and Training Courses America's Got Regulatory Science Talent Competition UCSF-Stanford CERSI Postdoctoral Fellowship in Regulatory Science Yale University-Mayo Clinic --> Contact the Office of Regulatory and Emerging Science: ORES@fda. hhs. gov