ETHICS IN THE PHARMACEUTICAL INDUSTRY

The development of a new drug is a long and expensive process, involving thousands of discrete processes and decisions. Most of these processes reflect some level of ethical diligence and may even be governed by local law. There are a range of formal mechanisms in place in the complex drug development industry (e.g., regulatory requirements, Institutional Review Boards, internal bioethics committees, legislative requirements) to ensure that ethical issues are considered and that best ethical practices are applied throughout the process. And yet, ethical challenges and considerations persist and evolve.   This online 3-credit course will examine some of the major components and drivers of the drug development process from an array of perspectives and analyze the ethical issues surrounding these constituent steps, stages, and components. The course is an elective in the Master of Science Bioethics program and is open, space permitting, to cross-registrants from other fields and/or Columbia University programs. The course is designed for anyone with an interest in the ethics of pharmaceutical product development and the research required to enable it. Registrants should have a foundational understanding of clinical research and development.