As medical treatments and technologies advance at an unparalleled pace — particularly in the field of regenerative medicine —  there is a need to develop new scientifically-based standards and metrics to assess the safety, efficacy, and quality of diagnostic and therapeutic products. Development of techniques and measurements to assess these characteristics of clinical products is known as “regulatory science.”

In 2016, Yale University and Mayo Clinic collaboratively established a Center for Excellence in Regulatory Science and Innovation (CERSI) program. CERSI programs — collaborations between the Food and Drug Administration (FDA) and academic institutions — aim to advance regulatory science through research, education and scientific exchanges. One of the goals of CERSI is to provide education in regulatory science research and affairs. As such, the Mayo Clinic Graduate School of Biomedical Sciences will offer a new course this summer: Introduction to Regulatory Science. During this in-person course, participants will learn about critical areas of regulatory science, as defined by the FDA’s “Advancing Regulatory Science” report, including:

• The role of bioethics in regulation
• Toxicology and product safety
• Innovations in the science and conduct of clinical trials
• Product manufacturing and quality
• Emerging technologies
• The use of informatics to improve health outcomes
• Regulatory processes, including the role of advisory committees and meetings

CERSI is coordinated through the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Mayo Clinic Knowledge and Evaluation Research Unit. Read more about the Yale and Mayo Clinic collaboration to further regulatory science on the Advancing the Science blog.

Tags: Mayo Clinic, News, policy, regulatory science, Science of Health Care Delivery, stem cells, Yale