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CHEM_ENG 382: Biotechnology Regulatory Science

Quarter Offered

Spring : MW 6:00 ; Felse

Description

Course topics cover the intersection of science, engineering, and biotech regulatory compliance. Includes: federal regulations for drug product development, regulatory compliance processes and organizational structure, interface between biotechnology processes and regulatory sciences, global harmonization of regulations, and regulatory documentation.

Textbook
None

Overview
Drug product development is a process with an inherent low probability of success that takes about 13 years and 2.6 billion dollars from lead discovery to product launch. Regulatory science is a discipline that helps drug companies and regulatory agencies to make science-based risk/benefit decisions on a new molecular entity (NME) that eventually leads to a decision on its approval. The rapidly growing science-based approach will to increase probability of success and decease drug development costs.

The regulatory sciences in biotechnology course will provide a unique educational experience at the intersection of science, engineering, and regulatory compliance. Topics such as federal regulations for drug product development, regulatory compliance processes and organizational structure, interface between biotechnology processes and regulatory sciences, global harmonization of regulations, and regulatory documentation will be covered in this course. One part of this course will be delivered as lectures, case-studies, and workshops and the other will be delivered as a hands-on, practicum team project in biotech regulatory science. The class will feature several guest lectures from professionals in the biotech and pharma industry.