Required courses:

Four courses are required for the Certificate in Regulatory Affairs.

RA 601. The Pharmaceutical, Biotechnology, and Medical Device Industries (3 units)
Prerequisite: Chemistry 361A or 365
Introduction to the pharmaceutical, biotechnology and medical device industries. General overview of company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control and marketing.

RA 602. Introduction to Food and Drug Law (3 units)
Prerequisite: To be taken either concurrently with or following RA 601
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.

*STUDENT MUST PURCHASE TEXT*

RA 770. Current Good Manufacturing Practice - General Concepts (3 units)
Prerequisite: Regulatory Affairs 602
Study of current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer’s organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records.

RA 781 - PRACTICAL ETHICS FOR HEALTHCARE PROFESSIONALS (3)
Prerequisite: Regulatory Affairs 602
Ethical issues confronting healthcare professionals.  Moral positions concerning impact on laboratory animals, human subjects, patients and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.