Regulation and Compliance in the Pharmaceutical Industry
This course explores the U.S. and international regulatory environments that govern the pharmaceutical and biotechnology industries with particular focus on the U.S. Food and Drug Administration, the European Agency for the Evaluation of Medical Products, and the Japanese Ministry of Health, Labor, and Welfare. The essential components of Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices regulations will be covered. Students will develop an understanding of the formulation and execution of regulatory strategy and key ethical issues in medical research. Where appropriate, case studies will be used to illustrate the challenges and issues associated with compliance, as well as the consequences of non-compliance. Ethical issues and the potential consequences of ethical lapses will also be explored. Current events will be used to illustrate key ethical principles and serve as a basis for discussion.