Instructor
Pilar Ossorio
Credentials: JD, PhD in Microbiology and Immunology
Position title: Professor of Law and Bioethics
University of Wisconsin Law School
Ethics Scholar-in-Residence
Morgridge Institute for Research
Course Overview
crb804: Biotechnology Regulation and Ethics
Year 1, Fall Semester (2 credits)
Saturday mornings, 8:00am – 12:00pm (every other week)
Irving Shain Conference Room, MGE Innovation Center
University Research Park
Since biotechnology emerged as an industry, political and ethical legal issues have shaped its development.
This course will expose you to some of the most important areas of regulation, including FDA oversight of gene therapy and drug, device and biologics development; EPA/USDA regulation of agricultural applications of biotechnology; federal regulation of genetic testing services; and the politics and regulation of embryonic stem cell research.
You’ll learn how regulation is developed and how it interacts with business and finance to influence the formation and growth of biotechnology companies.
You’ll also explore the ethical issues that help shape public policies on biotechnology and its applications.
Session Topics from Fall 2023
Session 1: Introduction to the US Government and Legal System; Introduction to the FDA
Session 2: FDA Regulation of Biotechnology – Medical Devices
Session 3: FDA Regulation of Biotechnology – Drug Development and Marketing
Session 4: FDA Regulation of Biotechnology – Biologics, Generics, Biosimilars
Session 5: Regulation and Ethics of Research with Human Participants
Session 6: Precision Medicine – Regulation and Ethics
Session 7: Discuss Papers; Ethical and Governance Issues in Genome Editing