The USD School of Law/SDSU College of Sciences Joint Certificate in Intellectual Property and Regulatory Affairs provides an interdisciplinary approach to broadening the knowledge base of life science professionals working to translate scientific discovery into commercial products.
• Learn the fundamentals of intellectual property law on campus at USD School of Law
• Develop foundational knowledge of regulatory affairs in SDSU’s fully online courses
• Earn your certificate in as little as one year
• Build professional skills that employers are seeking in science, law and business
Requirements
The certificate program requires completion of the following six courses. (Click on course number for more information.)
Introduction to laws governing drug, biological and medical device products. Discussion of Federal Food, Drug & Cosmetic Act, US Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments. Fee/Schedule[/expand]
Ethical issues confronting regulatory affairs professionals. Evaluate, defend, and discuss moral positions concerning impact on laboratory animals, human subjects, patients, and consumers. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice. Topics include the treatment of animals, trial design, informed consent, the operation of institutional review boards, international clinical trials, clinical trials and vulnerable populations, and whistle blowing. Fee/Schedule[/expand]
Covers the following: (1) the legal requirements and process to obtain a U.S. patent (i.e., patent prosecution); (2) methods of valuing, selling, and licensing patent rights; (3) patent litigation; and (4) public policy issues, particularly the role patents play in technological innovation and recent efforts to “reform” the patent laws. Fee: 3 units @ $1,590/unit. Schedule: Fall ’15, Mon/Wed from 5:30pm – 6:45pm.[/expand]
Surveys various intellectual property and regulatory issues important in the pharmaceutical industry, specifically those regarding FDA drug approval process, patent and technology licensing, various methods of receiving marketing exclusivity, and intellectual property issues and FDA regulations concerning drug product promotion and labeling, generic and biosimilar products, and product life cycle management. Course Fee: 3 units @ $1,590/unit. Schedule: Spring ’16, Thurs at 1:00pm (tentative).[/expand]
Any SDSU Regulatory Science course not required for the certificate may be taken as an elective, and/or any USD course on this list (pdf). Fee/Schedule[/expand]
To apply, see Admissions page. For more information, call 619-594-6030.