Master of Science in Biotechnology Program, UW-Madison

Find Us On: M.S. in Biotechnology program on Facebook M.S. in Biotechnology program on Twitter M.S. in Biotechnology program on LinkedIn M.S. in Biotechnology program on YouTube

Share
Loading

Course Descriptions

Biotechnology Regulation and Ethics

Instructor:

  • 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 2016

    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 H.R. 6 bill; Conduct Debate

    Question about the degree?
    Contact Bryan

    Bryan Husk
    Assistant Director
    Phone: (608) 265-0773
    bthusk@wisc.edu
    Contact Bryan Husk, Assistant Director, M.S. in Biotechnology Program, UW-Madison
    Class of 2018 Schedule

    Fall 2016 | Spring 2017
    Fall 2017 | Spring 2018

    Class of 2019 Schedule

    Fall 2017 | Spring 2018
    Fall 2018 | Spring 2019

    Class of 2020 Schedule

    Fall 2018 | Spring 2018
    Fall 2019 | Spring 2020