The following courses are all delivered through distance learning, with the following exceptions: RA 797 - Research, RA 798 - Special Study, RA 799 - Thesis or Project.

It is recommended that students take no more than two online courses at any one time. Students will not receive refunds for dropped courses.

RA 601 - THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES (3)
Prerequisite: Chemistry 361A or 365
Pharmaceutical, biotechnology and medical device industries. 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)
Prerequisite: To be taken either concurrently with or following RA 601
Laws governing drug, biological, and medial device products. Discussion of Federal Food, Drug & Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.

Students must purchase a REQUIRED TEXTBOOK.

ORDER THE REQUIRED TEXTBOOK

RA 605– MEDICAL/SCIENTIFIC WRITING FOR HEALTHCARE PROFESSIONALS (3)
Prerequisite: Regulatory Affairs 602
Foundational course introducing students to the kinds of writing done during the development of a new drug or biologic. Particular emphasis on the effective writing of project reviews, research reports, protocols, and CTDs.

RA 696 - ADVANCED TOPICS IN REGULATORY AFFAIRS (1-4)
Prerequisite: Consent of the Instructor
Current issues and topics in regulatory affairs evaluated and discussed. Recent developments and changes in selected areas of regulatory affairs presented by faculty and industry professionals. May be repeated with new content. Maximum credit six units applicable to the Master of Science degree in Regulatory Affairs.

RA 705 - PROJECT PLANNING FOR THE BIOMEDICAL INDUSTRY (3)
Prerequisite: Regulatory Affairs 602 or Consent of the Instructor
Introduction to project planning and coordination using pharmaceutical research & development as a pertinent example of the use of Microsoft Project software. This course may be taken by MS in RA students as an alternate to IDS 750.

RA 770 – CURRENT GOOD MANUFACTURING PRACTICE - GENERAL CONCEPTS (3)
Prerequisite: Regulatory Affairs 602
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 771 - CURRENT GOOD MANUFACTURING PRACTICE - ADVANCED TOPICS (3)
Prerequisite: Regulatory Affairs 770
Expanded analysis of current Good Manufacturing Practice regulations to assure quality of marketed drug and biological products. Discussions of FDA methods of enforcement by inspections of manufacturing establishments.

RA 772 - POST-APPROVAL ACTIVITIES, INCLUDING FDA ADVERTISING, PROMOTION AND LABELING (3)
Prerequisite: Regulatory Affairs 602
FDA and FTC rules and regulations governing advertising, promotion, and labeling for prescription drugs, biologics, medical devices, and over-the-counter drugs.

RA 773 - MEDICAL DEVICE REGULATIONS (3)
Prerequisite: Regulatory Affairs 602
Overview of laws and FDA regulations for medical devices, in vitro diagnostics, radiological devices, FDA jurisdiction, registration, listing, labeling requirements, classification, Investigational Device Exemptions (IDE), premarket approval (PMA), and premarket notification [510(k)].

RA 774 - INVESTIGATIONAL AND MARKETING APPLICATIONS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES (3)
Prerequisite: Regulatory Affairs 602
Examination of the development and informational content for: investigational new drug applications (IND), investigational device exemptions (IDE), new drug applications (NDA), product license application (PLA), and biologics license applications (BLA) for FDA review.

RA 775 - CLINICAL TRIALS: ISSUES IN DESIGN, CONDUCT and EVALUATION (3)
Prerequisite: Regulatory Affairs 602
Review of issues and requirements in the design, conduct and evaluation of clinical trials for new drugs, biologics, and medical devices. Includes introductions to biostatistics.

RA 776 - VALIDATION OF PHARMACEUTICALS, BIOLOGICS AND MEDICAL DEVICES (3)
Prerequisite: Regulatory Affairs 602
Broad coverage of all aspects of validation in the pharmaceutical, biologic, and medical device industries.

RA 778 - QUALITY CONTROL AND QUALITY ASSURANCE: PHARMACEUTICALS, BIOLOGICS, AND MEDICAL DEVICES (3)
Prerequisites: Regulatory Affairs 602
Review of requirements, procedures, controls and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices.

RA 779 - INTERNATIONAL MEDICAL REGULATIONS (3)

Prerequisite: Regulatory Affairs 602
Exploration of international medical regulations in their current status in many of the key areas of the world today. It also will contribute to an understanding of the changes brought about by multi-national projects due to cultural differences.

*Students must purchase required texts  For information about the texts please call 619-594-6030*

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.

RA 783 - EFFECTIVE COMMUNICATION FOR HEALTHCARE PROFESSIONALS (3)
Prerequisite: Regulatory Affairs 602
Advanced written, oral, and interpersonal communication strategies for the business environment. Audience analysis discussed, as well as cultural considerations and barriers to communication. Students will create various types of communications, including informational documentation, persuasive arguments, executive summaries, research-based articles or proposals, email communications, and effective visuals for presentations.

RA 797 - RESEARCH (1-3)
Prerequisite: Advancement to candidacy
Research in the area of regulatory sciences. Maximum credit six units to a master's degree.

RA 798 - SPECIAL STUDY (1-3)
Prerequisite: Consent of staff; to be arranged with department chair and instructor.
Individual study. Maximum credit six units applicable to a master's degree.

RA 799 - THESIS or PROJECT (3)
Prerequisite: An officially appointed thesis committee and advancement to candidacy.
Preparation of thesis or project for the Master's degree.