(WINTER 2010)

A required course in the Regulatory Affairs Management Specialized Studies Certificate and an elective course in the certificate program in Medical product Development.
Increase your knowledge of business and legal issues in the biomedical industry. Participants will learn to discern the rationale behind policies and procedures in a highly regulated industry. A top down approach is taken to introduce broad business and legal concepts and relating them specifically to design, development, and commercialization of medical device and pharmaceutical products. Topics include: corporate structure, corporate formation; and early stage financing, contracts, licensing, intellectual property, due diligence and sale. Prerequiste: BME X408 Medical product Lifecycle Management, or equivalent experience. See enrollment confirmation for login information.

Eric Alspaugh, JD, is a registered patent attorney specializing in advancing early stage companies to develop their intellectual property. Alspaugh has advised numerous pharmaceutical and medical device companies in all facets of clinical, quality, and regulatory requirements for US and international marketing approvals.