Learn the fundamentals of the drug and biologics regulatory approval process as it applies to US, Canadian and European markets. This course includes an overview of the regulations that must be met in order to initiate human clinical trials, the regulatory pathways for approval to market pharmaceuticals and biologics, an understanding of the clinical trials process, and the role of the regulatory professional in today’s pharmaceutical industry. At the end of the course, students will be asked to develop a global regulatory strategy for a biologic or drug pharmaceutical product.
This course can be applied towards:
Noncredit courses do not produce academic credit nor appear on a Colorado State University academic transcript.