Course Schedule

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.

Norma Schafer, MS, MT(ASCP), RAC is currently working as a Regulatory Affairs and Quality Assurance Executive Advisor at Renibus Therapeutics, Inc., with experience in prescription pharmaceuticals and medical devices and over-the-counter drug and device products.

Current Good Manufacturing Practices – General Concepts
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

Ajit Simh, M.S., is President of Shiba Associates, auditing and advising companies within the US, Europe, Japan, China and India on operating in compliance with US FDA and ICH requirements. In addition to being on the faculty of the Regulatory Science program at SDSU, he has been an instructor at the University of California, San Diego in the biomedical-manufacturing program since 1994 and is a member of the university advisory committee.

Clinical Trials: Issues in Design, Conduct and Evaluation
Review of issues and requirements in the design, conduct and evaluation of clinical trials for new drugs, biologics, and medical devices. Includes introduction to biostatistics. Prerequisite: Regulatory Affairs 602

Barney King, M.D., M.B.A., is Principal of Macnas Consulting International, Inc., a firm providing consulting services to pharmaceutical, biotechnology, medical device, and venture capital companies in the areas of corporate strategy, leadership development, change management and strategic product development.

Food and Drug Law
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: Prerequisite: Regulatory Affairs 601

Scott Harris, MS, RAC is currently Chief Operating Officer at Cleave Therapeutics Inc. He holds academic appointments at SDSU and CSUSM, where he teaches undergraduate and graduate courses in healthcare product regulation.

Investigational and Marketing Applications for Drugs and Biologics
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. Prerequisite: Regulatory Affairs 602
*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.

Norma Schafer, MS, MT(ASCP), RAC is currently working as a Regulatory Affairs and Quality Assurance Executive Advisor at Renibus Therapeutics, Inc., with experience in prescription pharmaceuticals and medical devices and over-the-counter drug and device products.

Ethics for Life Science Professionals
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. Prerequisite: Regulatory Affairs 602

Dr. Moellendorf is a Professor of International Political Theory and Professor of Philosophy at Goethe University, Frankfurt, Germany. He is Emeritus Professor of Philosophy at San Diego State University and former Director of the SDSU Institute for Ethics and Public Affairs. He is also a private consultant on regulatory affairs.

Lean Six Sigma for Quality Sciences Prepares students to solve business problems using Lean and Six Sigma methodologies and encourages exploration of ways to promote greater creativity and change even after “change” becomes the norm.

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Regulatory Intelligence/Strategy 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.

Kim Walker, M.S., RAC (US & EU), is Consultant & Owner of Kim Walker Consulting. Ms. Walker assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

Drug/Device Product Development and Regulation in Europe and the US
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.

Gautam Maitra, M.Sc., Fil.Lic., is currently responsible for Global Regulatory Strategy and External Affairs at AC Immune. He is an instructor in Regulatory Affairs at the Swiss Federal Institute of Technology, as well as adjunct faculty for the Regulatory Science Program at SDSU.

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.

Norma Schafer, MS, MT(ASCP), RAC is currently working as a Regulatory Affairs and Quality Assurance Executive Advisor at Renibus Therapeutics, Inc., with experience in prescription pharmaceuticals and medical devices and over-the-counter drug and device products.

Leadership for Change and Continuous Improvement
Covers all aspects of controlling and facilitating change at all levels within all types of companies. Takes the traditional quality tools, concepts and process improvement methods and applies them to the biotechnology industry. Students learn how to create strong relationships with upper management and peers, learning how to communicate expected financial returns resulting from a quality initiative and how to sell benefits of those initiatives in a consultative manner. Prerequisite: Graduate Standing

Dr. Bodie recently retired from her position as the Associate Director/Graduate Advisor for the Regulatory Affairs Programs. Lorah earned her doctoral degree from the San Diego State University – University of San Diego Joint Doctoral Program in Education with an emphasis in online teaching and learning in higher education environments.

Effective Communication for Regulatory Science
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. Prerequisite: Regulatory Affairs 602 and 605; Requires concurrent enrollment in RA798-Special Study (1-unit)
*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 Graduate Adviser.

Dr. Gretchen Vik, Ph.D., is Professor Emeritus, SDSU Department of Management and Information Systems. Professor Vik’s publications range from major Irwin texts to articles on basic business communication testing programs, training package development, collaborative writing projects, internship programs and other experiential learning, and computer screen design.

Special Study
Required as concurrent enrollment for RA783

Dr. Gretchen Vik, Ph.D., is Professor Emeritus, SDSU Department of Management and Information Systems. Professor Vik’s publications range from major Irwin texts to articles on basic business communication testing programs, training package development, collaborative writing projects, internship programs and other experiential learning, and computer screen design.

Food and Drug Law
Discussion of Federal Food, Drug & Cosmetic Act, US Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments. Prerequisite: Regulatory Affairs 601

Scott Harris, MS, RAC is currently Chief Operating Officer at Cleave Therapeutics Inc. He holds academic appointments at SDSU and CSUSM, where he teaches undergraduate and graduate courses in healthcare product regulation.

Medical/Scientific Writing for Life Science Professionals
Emphasis on the rhetorical aspects of argumentation in scientific writing, reporting lab results, and analyzing scientific literature to write up a critical appraisal of a drug. Prerequisite: Regulatory Affairs 601

Linn K. Bekins, Ph.D., is an Associate Professor in the SDSU Department of Rhetoric & Writing Studies, and Director of the Technical and Scientific Writing Advanced Certificate Program.

Rita Tomlin, M.A., MT (ASCP), is a consultant who provides medical writing and editing services to pharmaceutical and biotechnology companies.

International Regulatory Affairs
Exploration of international medical regulations in their current status in many of the key areas of the world today. Contributes to an understanding of the changes brought about by multinational projects due to cultural differences. Prerequisite: Regulatory Affairs 602

Kim Walker, M.S., RAC (US & EU), is Consultant & Owner of Kim Walker Consulting. Ms. Walker assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

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.

Norma Schafer, MS, MT(ASCP), RAC is currently working as a Regulatory Affairs and Quality Assurance Executive Advisor at Renibus Therapeutics, Inc., with experience in prescription pharmaceuticals and medical devices and over-the-counter drug and device products.

Current Good Manufacturing Practices – General Concepts
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

Ajit Simh, M.S., is President of Shiba Associates, auditing and advising companies within the US, Europe, Japan, China and India on operating in compliance with US FDA and ICH requirements. In addition to being on the faculty of the Regulatory Science program at SDSU, he has been an instructor at the University of California, San Diego in the biomedical-manufacturing program since 1994 and is a member of the university advisory committee.

Clinical Trials: Issues in Design, Conduct and Evaluation
Review of issues and requirements in the design, conduct and evaluation of clinical trials for new drugs, biologics, and medical devices. Includes introduction to biostatistics. Prerequisite: Regulatory Affairs 602

Barney King, M.D., M.B.A., is Principal of Macnas Consulting International, Inc., a firm providing consulting services to pharmaceutical, biotechnology, medical device, and venture capital companies in the areas of corporate strategy, leadership development, change management and strategic product development.

Food and Drug Law
Discussion of Federal Food, Drug & Cosmetic Act, US Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments. Prerequisite: Regulatory Affairs 601

Scott Harris, MS, RAC is currently Chief Operating Officer at Cleave Therapeutics Inc. He holds academic appointments at SDSU and CSUSM, where he teaches undergraduate and graduate courses in healthcare product regulation.

Medical Device Regulations
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)]. Prerequisite: Regulatory Affairs 602

Kim Walker, M.S., RAC (US & EU), is Consultant & Owner of Kim Walker Consulting. Ms. Walker assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

Ethics for Life Science Professionals
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. Prerequisite: Regulatory Affairs 602

Dr. Moellendorf is a Professor of International Political Theory and Professor of Philosophy at Goethe University, Frankfurt, Germany. He is Emeritus Professor of Philosophy at San Diego State University and former Director of the SDSU Institute for Ethics and Public Affairs. He is also a private consultant on regulatory affairs.