Regulation and Compliance in the Pharmaceutical Industry (MGT684 or PME542)

This course explores the US and international regulatory environments that govern the pharmaceutical and biotechnology industries with particular focus on the US 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.

Potential topics include:

•  Regulatory agencies and their mandates
•  Legislative mandates
•  Regulatory aspects of the drug development process
•  Regulatory strategy
•  Ethics of medical research
•  The International Conference on Harmonization (ICH)
•  The approval process
•  Validation
•  Other regulations affecting the pharmaceutical and biotechnology industry
•  Ethical challenges and the consequences of non-compliance