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.
UCSF-Stanford CERSI offers short intensive courses focused on regulation of medical products and current issues in regulatory sciences.
Regulatory Overview of Drug Development
- Introduction to FDA Drug Regulation
- Early Drug Development and Clinical Pharmacology
- Regulatory Considerations for Drug Development in Phases 2 and 3
- Adding Value to Drug Development – Biomarkers, Precision Medicine, and CDx Development Programs
- Postmarketing Regulatory Considerations for Drugs
Regulatory Overview of Medical Device Development
- Introduction to U.S. Device Regulation
- Regulatory Strategies for Medical Device Market Clearance – the 510(k) pathway
- The Medical Device Development Process and Quality System Regulations
- Regulatory Framework for Mobile Medical Technologies
Regulatory Science Principles and Applications
- Introduction to pharmacogenomics (online, self-paced)
- Therapeutic Target Validation and Large Molecule Discovery
PSPG/CERSI Seminar Series
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.
UCSF-Stanford CERSI YouTube Channel
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-Stanford CERSI Postdoctoral Fellowship Program
UCSF-Stanford CERSI offers an experiential postdoctoral training in regulatory sciences. Information and application details
UCSF-Stanford CERSI Scholars Program
UCSF-Stanford CERSI recognizes trainees at UCSF and Stanford University who are pursuing training in regulatory sciences with a $5,000 award. Information and application details
UCSF-Stanford CERSI Internship Program
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.
UCSF programs and courses
The center builds on the already UCSF-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)
- UCSF American Course on Drug Development and Regulatory Sciences (ACDRS)
- UCSF Pharmacokinetics for Pharmaceutical Scientists (PK Course)