Prerequisites: BIOT W4200 (OK without prerequisite). This course will provide a practical definition of the current role of the Regulatory Professional in pharmaceutical development, approval and post-approval actions. This will be illustrated by exploration, and interactive discussion of regulatory history, its evolution, current standards, and associated processes. The course will seek to clarify the role of Regulatory in development and lifecycle opportunities, demonstrating the value Regulatory adds by participation on research, development and commercial teams. The course will utilize weekly case studies and guest lecturers to provide color to current topical events related to the areas.