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 Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

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., President, Shiba Associates. Ajit Simn earned his Master’s degree in Cell Biology from St. Louis University, St. Louis, Missouri.
Ajit is a member of the university advisory committee and was recently appointed adjunct professor at San Diego State University in the Bio-device and Biomedical graduate studies program offering a Master’s degree in Regulatory Affairs. He is a member of the advisory committee to the Bio-Pharm Journal. He is affiliated with the Parenteral Drug Association (PDA) and IBC offering short courses in cGMP requirements and auditing foreign API manufacturers.

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., Principal of Macnas Consulting International, Inc. Dr. King 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.
Dr. King graduated cum laude from the University of Notre Dame, and received his MD from the Ohio State University College of Medicine. He is board certified in Cardiology and Internal Medicine. He received his MBA from the Wharton School of the University of Pennsylvania.

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 Executive Vice President of Regulatory Affairs and Technical Operations at Adynxx Inc., where he is responsible for global regulatory oversight, quality assurance and CMC. Mr. Harris obtained a M.S. in Regulatory Affairs from SDSU and a BS in Biochemistry and Cell Biology from UCSD. 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), Consultant & Owner, 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.
Ms. Walker graduated from an SEC university with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University. Ms. Walker has served on the OCRA Program Committee since 2003, served on the OCRA Board of Directors 2004-2010, and was the 2008-2009 President.

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

Darrel Moellendorf, Ph.D., Emeritus Professor of Philosophy at SDSU; Professor of International Political Theory, Goethe University, Frankfurt, Germany; Former Director of the SDSU Institute for Ethics and Public Affairs is an Associate Professor of Philosophy and the Director of the Institute for Ethics and Public Affairs at San Diego State University. Darrel is the author of several articles and chapters in books on ethics and political philosophy, and of the book Cosmopolitan Justice (Westview Press, 2002).

Post-Approval Activities, Including Advertising, Promotion and Labeling 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. Prerequisite: Regulatory Affairs 602

Norma Schafer, MS, MT(ASCP), RAC is Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

Quality Control and Quality Assurance: Pharmaceuticals, Biologics and Medical Devices Review of requirements, procedures, controls and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices. Prerequisite: Regulatory Affairs 602

Ajit Simh, M.S., President, Shiba Associates. Ajit Simn earned his Master’s degree in Cell Biology from St. Louis University, St. Louis, Missouri. Ajit is a member of the university advisory committee and was recently appointed adjunct professor at San Diego State University in the Bio-device and Biomedical graduate studies program offering a Master’s degree in Regulatory Affairs. He is a member of the advisory committee to the Bio-Pharm Journal. He is affiliated with the Parenteral Drug Association (PDA) and IBC offering short courses in cGMP requirements and auditing foreign API manufacturers.

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 Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

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 is 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
*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.

Dr. Gretchen Vik, Ph.D., Professor, Management and Information Systems Department, SDSU. Dr. Gretchen Vik has taught at San Diego State University since 1975 in the College of Business Administration. 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. Her current research interests focus on accounting communication and e-mail format and style. She was past president of the Association for Business Communication, and served on the board of the Association for Business Simulation and Experiential Learning.

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 has over 14 years of experience in two of Forbes top-ranked pharmaceutical companies, Roche and Novartis. At Novartis, he was in charge of regulatory support for both marketed and early development products. He is currently responsible for Global Regulatory Strategy and External Affairs at AC Immune. He has conducted pre-IND meetings with FDA and Scientific Advice meetings with numerous international regulatory agencies. Under his leadership, the AC Immune regulatory department filed clinical study applications in Austria, Denmark, Sweden, UK and Finland, and an IND in the US. Gautam served as European Director of PDA. Until 2015, he was on the RAPS Board of Directors and the President of the RAPS Swiss Affiliate. Gautam has a M.Sc. degree in Analytical Chemistry and Fil.Lic. in Organic Analytical Chemistry from the University of Stockholm, Sweden. 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.

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 Executive Vice President of Regulatory Affairs and Technical Operations at Adynxx Inc., where he is responsible for global regulatory oversight, quality assurance and CMC. Mr. Harris obtained a M.S. in Regulatory Affairs from SDSU and a BS in Biochemistry and Cell Biology from UCSD. 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

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

Gautam Maitra has over 14 years of experience in two of Forbes top-ranked pharmaceutical companies, Roche and Novartis. At Novartis, he was in charge of regulatory support for both marketed and early development products. He is currently responsible for Global Regulatory Strategy and External Affairs at AC Immune. He has conducted pre-IND meetings with FDA and Scientific Advice meetings with numerous international regulatory agencies. Under his leadership, the AC Immune regulatory department filed clinical study applications in Austria, Denmark, Sweden, UK and Finland, and an IND in the US. Gautam served as European Director of PDA. Until 2015, he was on the RAPS Board of Directors and the President of the RAPS Swiss Affiliate. Gautam has a M.Sc. degree in Analytical Chemistry and Fil.Lic. in Organic Analytical Chemistry from the University of Stockholm, Sweden. 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 Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

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., President, Shiba Associates. Ajit Simn earned his Master’s degree in Cell Biology from St. Louis University, St. Louis, Missouri.
Ajit is a member of the university advisory committee and was recently appointed adjunct professor at San Diego State University in the Bio-device and Biomedical graduate studies program offering a Master’s degree in Regulatory Affairs. He is a member of the advisory committee to the Bio-Pharm Journal. He is affiliated with the Parenteral Drug Association (PDA) and IBC offering short courses in cGMP requirements and auditing foreign API manufacturers.

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., Principal of Macnas Consulting International, Inc. Dr. King 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.
Dr. King graduated cum laude from the University of Notre Dame, and received his MD from the Ohio State University College of Medicine. He is board certified in Cardiology and Internal Medicine. He received his MBA from the Wharton School of the University of Pennsylvania.

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 Executive Vice President of Regulatory Affairs and Technical Operations at Adynxx Inc., where he is responsible for global regulatory oversight, quality assurance and CMC. Mr. Harris obtained a M.S. in Regulatory Affairs from SDSU and a BS in Biochemistry and Cell Biology from UCSD. 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 Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

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

Darrel Moellendorf, Ph.D., Emeritus Professor of Philosophy at SDSU; Professor of International Political Theory, Goethe University, Frankfurt, Germany; Former Director of the SDSU Institute for Ethics and Public Affairs is an Associate Professor of Philosophy and the Director of the Institute for Ethics and Public Affairs at San Diego State University. Darrel is the author of several articles and chapters in books on ethics and political philosophy, and of the book Cosmopolitan Justice (Westview Press, 2002).

3-units of elective courses in regulatory “hot topics”

3-units of elective courses in regulatory “hot topics”

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 Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).

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 is 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
*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., Professor, Management and Information Systems Department, SDSU. Dr. Gretchen Vik has taught at San Diego State University since 1975 in the College of Business Administration. 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. Her current research interests focus on accounting communication and e-mail format and style. She was past president of the Association for Business Communication, and served on the board of the Association for Business Simulation and Experiential Learning.

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 Executive Vice President of Regulatory Affairs and Technical Operations at Adynxx Inc., where he is responsible for global regulatory oversight, quality assurance and CMC. Mr. Harris obtained a M.S. in Regulatory Affairs from SDSU and a BS in Biochemistry and Cell Biology from UCSD. 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., Associate Professor, Department of Rhetoric & Writing Studies, Director of the Technical and Scientific Writing Advanced Certificate Program, SDSU. Dr. Bekins earned her Ph.D. in Education, emphasizing rhetoric and composition, from the University of Utah, Salt Lake City. Currently, she directs the Professional Writing Certificate Program at San Diego State University (SDSU) and is an Associate Professor in the Department of Rhetoric and Writing Studies.

Rita Tomlin, M.A., MT (ASCP), Medical Writing Consultant. Ms. Tomlin is a consultant who provides medical writing and editing services to pharmaceutical companies.
Ms. Tomlin holds a Graduate Certificate in Science and Technical Writing from SDSU, 2004; and a Master’s of Arts degree in Rhetoric and Writing Studies at SDSU, 2007.

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

Gautam Maitra has over 14 years of experience in two of Forbes top-ranked pharmaceutical companies, Roche and Novartis. At Novartis, he was in charge of regulatory support for both marketed and early development products. He is currently responsible for Global Regulatory Strategy and External Affairs at AC Immune. He has conducted pre-IND meetings with FDA and Scientific Advice meetings with numerous international regulatory agencies. Under his leadership, the AC Immune regulatory department filed clinical study applications in Austria, Denmark, Sweden, UK and Finland, and an IND in the US. Gautam served as European Director of PDA. Until 2015, he was on the RAPS Board of Directors and the President of the RAPS Swiss Affiliate. Gautam has a M.Sc. degree in Analytical Chemistry and Fil.Lic. in Organic Analytical Chemistry from the University of Stockholm, Sweden. 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.