Course Descriptions

The following courses are all delivered through distance learning, with the following exceptions: RA 797 – Research, RA 798 – Special Study.

Please refer to the Course Materials page for information about ordering textbooks.

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 – Pharmaceutical, Biotechnology and Medical Device Industries (3 units)
Introduction and foundational knowledge of pharmaceutical, biotechnology and medical device industries. Company organization, product development and commercialization-associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control, marketing and post-marketing surveillance.

RA 602 – Food and Drug Law (3 units)
Prerequisite: Regulatory Affairs 601
Laws and regulations enforced by FDA for biotechnology, pharmaceutical, medical device, and related industries. US legal system; the Food, Drug and Cosmetic Act and related laws; the Freedom of Information Act; laws and regulations affecting foods, cosmetics, drugs, biologics, veterinary products, devices and diagnostics, and tobacco products; FDA enforcement; product liability, import/export requirements, orphan products, combination products, and overview of international regulations.

RA 605 – Medical/Scientific Writing for Life Science Professionals (3 units)
Prerequisite: Regulatory Affairs 601
Writing conducted during development of a new drug or biologic. Emphasis on effective writing in regulatory documents, e.g., informed consents, reports of lab results, and analyses of scientific literature for critical appraisal of drugs.

RA 696 – Advanced Topics in Regulatory Affairs (1-4 units)
Prerequisite: Consent of Graduate Advisor
Various “hot topic” courses in Regulatory Affairs. Possible offerings include:

  • Introduction to Electronic Submissions (3)
    This course will provide an introduction to current and future elements of electronic submissions for drug, biologic, and device submissions to health authorities. Electronic Common Technical Document (eCTD) and eCopy format will be covered. The course includes software instruction and a practicum to give students the opportunity to create content, assign content to an XML backbone, hyperlink documents, and validate compliance. NOTE: This course requires purchase of docuBridge ONE software ($300), for PCs only, and Adobe Acrobat Professional.
  • Regulatory Intelligence/Strategy (2)
    Regulatory intelligence involves gathering, monitoring, analyzing, and communicating regulatory information. This intelligence shapes regulatory strategy for product development and submission routes. This course develops the skills of regulatory affairs professionals to prepare and use regulatory intelligence to develop regulatory strategy recommendations.
  • GXP Audits (1)
    GXP audits are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course familiarizes students with GXP audit activities and helps regulatory affairs professionals develop the skills to participate in the preparation, hosting, and follow-up to GXP audits.
  • Pre-Approval Inspections (1)
    Students learn the requirements for hosting successful US FDA Pre-Approval Inspections (PAI) for small and large molecules, how to effectively interpret and apply current Good Manufacturing Practices (cGMPs), and the differences between FDA and EU requirements for the manufacture and control of pharmaceuticals.

RA 705 – Project Planning for the Biomedical Industries (3 units)
Prerequisite: Graduate Standing
Introduction to project planning and management for the biomedical industries. Strategies for planning, scheduling, and effective management of regulatory affairs activities and related tasks associated with project development are covered. Course assignments will utilize Microsoft Project software.

RA 750 – Leadership for Change and Continuous Improvement (3 units)
Prerequisite: Graduate Standing
Control and facilitation of change at a variety of levels within all types of companies, particularly those within the biotechnology industry, with the goal of strategic improvement to increase competitive advantage. Utilization of quality and statistical tools, concepts and process improvement methods, and application to management and leadership challenges as well as production and manufacturing issues.

RA 770 – Current Good Manufacturing Practices – General Concepts (3 units)
Prerequisite: Regulatory Affairs 602
Interpretation and application of the current Good Manufacturing Practices (cGMPs) to drug substance and drug product manufacture. Differentiation between the “Full GMPs” required for commercial manufacturing and “Appropriate GMPs ” required for clinical supplies production. Differences between the US FDA requirements and the European Union’s requirements for the manufacture and control of pharmaceuticals. Aseptic processing and preparing for regulatory inspections also covered.

RA 772 – Post-Approval Activities, Including Advertising, Promotion and Labeling (3 units)
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 and generic drugs. Additional topics covered include annual reporting requirements, changes to approved marketing applications, post-marketing adverse reaction reporting, GMP inspections, product recalls, and risk management.

RA 773 – Medical Device Regulations (3 units)
Prerequisite: Regulatory Affairs 602
Comprehensive introduction to regulatory affairs requirements for the Medical Device industry through every stage of product development. FDA medical device regulations, terminology, timelines, and actual steps followed by RA professionals. Operational, strategic, and commercial aspects of the regulatory approval process for medical devices and in vitro diagnostics (IVD). Strategic, regulatory intelligence, risk management, and marketing considerations.

RA 774 – Investigational and Marketing Applications for Drugs and Biologics (3 units)
Prerequisite: Regulatory Affairs 602
Strategy, planning, content, and requirements for developing and preparing Food and Drug Administration regulatory submissions including investigational new drug applications (IND), investigational device exemptions (IDE), new drug applications (NDA), biologics license applications (BLA), device premarket applications (PMA), device premarket notifications (510(k)), etc. Special topics discussed include risk management and combination product submissions, and future submission trends.
*Note: It is not recommended that students take a second course at the same time this course is taken if they also have a full-time job. If you have questions, please consult with the instructor.

RA 775 – Clinical Trials: Issues in Design, Conduct and Evaluation (3 units)
Prerequisite: Regulatory Affairs 602
Elements and issues in design, conduct and evaluation of clinical trials by pharmaceutical, biotechnology and medical device companies for marketing approval of products being studied in humans. Begins with “macro” view of clinical trials within corporate, legal, and regulatory environments and proceeds to each key element required to develop and execute a successful clinical development program.

RA 778 – Quality Control and Quality Assurance: Pharmaceuticals, Biologics and Medical Devices (3 units)
Prerequisite: Regulatory Affairs 602
Quality and compliance function in pharmaceutical and biotechnology companies and current trends in industry. Quality control (QC) role vs. quality assurance (QA) role. Good Laboratory Practices (GLPs). Use of “Graded” approach to manufacture Active Pharmaceutical Ingredients (API’s), with focus on biologics and drugs and some discussion of medical device regulations. Developing product specifications, writing effective process deviations to be in compliance, and addressing out of specification results.

RA 779 – International Regulatory Affairs (3 units)
Prerequisite: Regulatory Affairs 602
International medical regulations pertaining to the development and commercialization of medical devices, biologics and pharmaceuticals. Emphasis on European Union and other key areas of the world.

RA 781 – Ethics for Life Science Professionals (3 units)
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.

RA 783 – Effective Communication for Life Science Professionals (3 units)
Prerequisite: Regulatory Affairs 602
Advanced written, oral, and interpersonal communication strategies for the business environment, with an emphasis on regulatory affairs. Audience analysis, cultural considerations, and barriers to communication discussed. Types of communications covered include informational documentation, persuasive arguments, executive summaries, research-based proposals, visuals for presentations and email communications.
*Note: It is not recommended that students take a second course at the same time this course is taken if they also have a full-time job. If you have questions, please consult with the instructor.

RA 797 – Research (1-3 units)
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 units)
Prerequisite: Consent of staff; to be arranged with department chair and instructor.
Individual study. Maximum credit six units applicable to a master’s degree.