(formerly BIOT W4200)
The program aims to provide current life sciences students with an understanding of what drives the regulatory strategies that surround the development decision making process, and how the regulatory professional may best contribute to the goals of product development and approval. To effect this, we will examine operational, strategic, and commercial aspects of the regulatory approval process for new drug, biologic, and biotechnology products both in the United States and worldwide. The topics are designed to provide a chronological review of the requirements needed to obtain marketing approval. Regulatory strategic, operational, and marketing considerations will be addressed throughout the course. We will examine and analyze the regulatory process as a product candidates are advanced from Research and Development, through pre-clinical and clinical testing, to marketing approval, product launch and the post-marketing phase. The goal of this course is to introduce and familiarize students with the terminology, timelines, and actual steps followed by Regulatory Affairs professionals employed in the pharmaceutical or biotechnology industry. Worked examples will be explored to illustrate complex topics and illustrate interpretation of regulations.