Master of Science in Biotechnology Program, UW-Madison

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Course Descriptions

Biotechnology Regulation and Ethics


  • Pilar Ossorio, Ph.D., J.D.
  • 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.

    Here are some of the topics taught in this course:

    Session Topics from Fall 2019

    Session 1: Introduction to the US Legal System; Introduction to the U.S. FDA

    Session 2: FDA Regulation of Biotechnology I – Drugs

    Session 3: FDA Regulation of Biotechnology II — Biologics and Devices

    Session 4: Drug Marketing and the First Amendment;
    Ethics and Regulation of Research With Human Participants

    Session 5: Regulation of Industrial Chemical Production Using Biotechnology: EPA, FDA, and USDA

    Session 6: Regulation and ethics of genomic and other omic testing; Ethics of Gene Editing in Humans

    Session 7: Discussion of Student Papers on US Senate Bill S. 204, "Right to Try Act of 2017"

    Question about the degree?
    Contact Bryan

    Bryan Husk
    Assistant Director
    Phone: (608) 265-0773
    Contact Bryan Husk, Assistant Director, M.S. in Biotechnology Program, UW-Madison
    Class of 2021 Schedule

    Fall 2019 | Spring 2020
    Fall 2020 | Spring 2021

    Class of 2022 Schedule

    Fall 2020 | Spring 2021
    Fall 2021 | Spring 2022

    Class of 2023 Schedule

    Fall 2021 | Spring 2022
    Fall 2022 | Spring 2023

    Class of 2024 Schedule

    Fall 2022 | Spring 2023
    Fall 2023 | Spring 2024