• Skip to main content

Regulatory Science

  • Home
  • Programs
    • Master of Science in Regulatory Affairs
      • Program Description
      • Degree Requirements
    • Advanced Certificate in Regulatory Affairs
    • Testimonials
  • Courses
    • Course Schedule
    • Course Descriptions
    • Course Fees
    • Course Materials
    • Register for a Course
    • Drop a Course
  • Admissions
    • Admissions Process
      • MS in Regulatory Affairs
      • Advanced Certificate in RA
    • Selection Criteria
    • International Students
  • People
    • Administrators & Staff
    • Faculty/Advisory Board
    • Students and Alumns
  • FAQ
  • Resources
    • SDSU
      • WebPortal
      • Blackboard
      • Graduate Bulletin
      • Requirements for Graduate Admission
      • University Policy
      • Bookstore
      • Library
      • International Student Center
      • Financial Aid
    • Industry
      • FDA
      • RAPS
      • SDRAN
      • BIOCOM
You are here: Home / Joint Certificate in Intellectual Property and Regulatory Affairs

Joint Certificate in Intellectual Property and Regulatory Affairs

Dowdy Bodie Card Final SP15_Page_1_CropDoubleSize

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.)

[expand title=”SDSU RA602: Food and Drug Law (Required)”]
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]
[expand title=”SDSU RA781: Ethics for Life Science Professionals (Required)”]
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]
[expand title=”USD LWIP 570: Patent Law (Required)”]
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]
[expand title=”USD LWIP 535: Survey of Pharmaceutical Law & Policy (Required)”]
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]
[expand title=”Plus 2 Electives”]
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.

Copyright © 2021 · Center for Regulatory Science at San Diego State University