The following courses are all delivered online.
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 full 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; elective)
Prerequisite: Consent of Graduate Advisor
Various “hot topic” courses in Regulatory Affairs.
RA 696 – eSTAR Submissions (1 unit; elective)
This class will introduce and familiarize students with the U.S. FDA medical device regulatory premarket submissions using the electronic Submission Template and Resource (eSTAR). This course will focus on the most recent eSTAR versions for both in vitro diagnostic (IVD) and non-IVD submissions (both 510(k) Premarket Notification and De Novo applications). Most critically, it will help students understand FDA’s expectations on how to appropriately complete the file for review. The various requirements of the template will be explained, including biocompatibility, software, cybersecurity, electrical safety, electromagnetic compatibility, interoperability, sterility, packaging, shelf-life and performance testing (bench, animal and clinical). The course will also discuss best practices on how to respond to FDA requests for Additional Information and potential pathways for FDA engagement before and during the premarket review process.
RA 696 – In Vitro Diagnostic (IVD) Regulations (3 units; elective)
Overview of laws and FDA regulations for Total Product Lifecycle management of in vitro diagnostics (IVDs). Topics covered will include IVD clinical trial requirements, pre-market submissions (i.e., 510[k]s, De Novos, & PMAs), establishment registration, listing, labeling requirements, classification, strategic considerations, personalized medicine, companion diagnostics, laboratory developed tests (LDTs), and post-market requirements. This course will provide a comprehensive introduction to the regulatory affairs requirements related to the IVD industry.
RA 701 – Regulatory Intelligence/Strategy (2 units; elective)
Prerequisite: Consent of Graduate Advisor
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.
RA 702 – Pre-Approval Inspections (1 unit; elective)
Prerequisite: Consent of Graduate Advisor
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 703 – Introduction to Electronic Submissions (3 units; elective)
Prerequisite: Consent of Graduate Advisor
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 (PCs only) and Adobe Acrobat Professional.
RA 705 – Project Planning for the Biomedical Industries (3 units; elective)
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 761 – Drug/Device Product Development and Regulation in Europe and the US (1 unit; elective)
Prerequisite: Consent of Graduate Advisor
This course covers the basic concepts of drug/device development, and regulatory and quality requirements in Europe and the US. It provides exposure to emerging professions in the life science industry and builds skills interacting with these professionals in international environments.
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; elective)
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), new drug applications (NDA), biologics license applications (BLA), 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; elective)
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 Regulatory Science (3 units)
Prerequisite: Regulatory Affairs 602 and Regulatory Affairs 605
Requires enrollment in RA798 (1 unit)
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. The Capstone Paper required for the MS degree is completed in this course.
*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.