The primary educational mission of UCSF-Stanford CERSI is to prepare a new generation of regulatory scientists by providing a range of opportunities and experiences to broaden their knowledge about tools, methods, and standards to support regulatory science and medical product development. We work toward this mission by providing foundational knowledge in regulatory sciences, supporting experiential training in mission-driven research, and through educational outreach.
Below you will find some of the programs and lecture series that we offer.
This online course is offered each fall quarter. Participants will gain a comprehensive and rigorous overview of regulatory and scientific considerations for the medical product development, including drug discovery, drug development, and regulation. The course is taught primarily by industry subject matter experts and consist of lectures and interactive discussion of case studies. A Statement of Completion is offered to participants who successfully complete all coursework.
Registration for the Fall 2023 CERSI Immersion is closed.
A two-year, experiential postdoctoral training program in regulatory sciences with an emphasis on pharmacometrics and clinical pharmacology.
A three-year, experiential postdoctoral training program in regulatory sciences.
This joint FDA and UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) speaker series consists of one-hour virtual lectures on cybersecurity topics with application to medical device security and biomedical engineering. The key goal is to introduce key concepts of cybersecurity science and engineering via distinguished academic speakers to the biomedical engineering and manufacturing communities. Topics covered include human factors for cybersecurity, trustworthy medical device software, security engineering for machine learning, cybersecurity of computer vision, threat modeling, software bills of materials, software safety, cybersecurity regulations, and the science of cybersecurity. This speaker series is an educational opportunity, not intended to discuss FDA policy.
To encourage a diverse workforce in regulatory science and promote research on issues of health equity, the UCSF-Stanford CERSI Scholars Program in Regulatory Science recognizes trainees at UCSF and Stanford University who are underrepresented minorities and encourages them to seek opportunities to participate in and advance the field of regulatory science with a $1,500 award.
Due to limited resources, this program is not currently accepting applications.
FDA-CERSI Lecture Series
The FDA's CERSI Lecture Series are an annual series of talks presented by investigators from each of the four CERSI academic institutions. They highlight a variety of regulatory science research topics ranging from new technologies in precision medicine, to leveraging existing data to better inform regulatory decision making, to streamlining real world data capture and analysis in the era of COVID-19.
UCSF-Stanford CERSI is committed to developing an open-access library of video lectures and seminars in regulatory science:
- UCSF-Stanford CERSI Education YouTube Channel: Regulatory Science eLearning
- UCSF-Stanford CERSI Seminars YouTube Channel: Innovation and Excellence in Regulatory Science\
UCSF Programs and Courses
The center builds on the already UCSF- and Stanford-prominent programs in translational and regulatory science —providing a foundation of integrated knowledge in science-based medical product development and regulation ranging from pre-clinical through post-marketing issues in regulatory science:
- UCSF/Berkeley Master of Translational Medicine Program (MTM)
- Stanford Master of Science in Translational Research and Applied Medicine (M-TRAM)
- UCSF American Course on Drug Development and Regulatory Sciences (ACDRS)
- UCSF Pharmacokinetics for Pharmaceutical Scientists (PK Course)
The University of California, San Francisco (UCSF) in partnership with the United States Pharmacopeia (USP) Quality Institute offers a fellowship in quality of medical products, with specific focus on the quality of excipients.
This program is not currently accepting applications.
UCSF-Stanford CERSI offers short online courses focused on regulation of medical products and current issues in regulatory sciences for medical products.
- Introduction to pharmacogenomics
- Mobile Health: Industry Overview and the Evolving Regulatory Framework
Due to limited resources, these courses are currently suspended.
UCSF-Stanford CERSI, in partnership with UCSF PSPG program, hosts bi-weekly seminars in pharmaceutical sciences, pharmacogenomics and regulatory science by visiting lecturers, faculty members, and advanced graduate students.
Due to limited resources, UCSF-Stanford CERSI does not currently participate in the PSPG Seminar Series.
The goal of the internships is to provide hands-on experience with practical problems faced by regulatory agencies in developing and approving therapeutic products. FDA internships (in planning) will allow trainees to see how safety reports are used for quantitative predictions of risk and to understand and participate in the drafting of FDA guidance related to drug safety and other issues. Internships will provide an expanded view of the FDA that is inaccessible to academics.
Due to limited resources, this program is currently suspended.