The Advanced Certificate in Regulatory Affairs is a four-course subset of the Masters Degree Program that provides foundational knowledge in the regulatory field. All four courses are transferable to the Masters Degree.
Note that you must have completed a baccalaureate degree before enrolling in a course that you wish to transfer into the Advanced Certificate or Masters Degree Program. However, students can take courses for professional development without having a baccalaureate degree or applying to the University.
Students who are in the process of applying may take up to two courses before being admitted to the University. You must be accepted to the University before you take your third course.
Four courses are required for the Advanced Certificate in Regulatory Affairs with a GPA of 3.0 or better:
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.
Prerequisite: Regulatory Affairs 602
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.
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.
Prerequisite: Regulatory Affairs 602
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.
To apply, see Admissions page. For more information, call 619-594-6030.