In the United States, biomedical products must gain regulatory approval from the Food and Drug Administration (FDA) not only for marketing and commercial sales, but also for product development and testing. Much of the product information submitted to the FDA for regulatory approvals is based on data collected from human clinical trials. One of the most critical workforce needs in the life sciences industry today is for human clinical trials managers, clinical research associates, clinical data coordinators and regulatory affairs managers. To help educate potential employees, the BayBio Institute has compiled titles and descriptions for jobs in clinical development and regulatory affairs. The CSU provides a breadth of courses to prepare students for careers in clinical trials and regulatory affairs.
Resources:
Association of Clinical Research Professionals (ACRP)
Society of Clinical Research Associates (SoCRA)
Regulatory Affairs Professionals Society (RAPS)
Orange County Regulatory Affairs (OCRA)
BIOL 503 Biotechnology Law and Regulation (Online)
Individual and organizational responsibility in R&D and commercial aspects of biotechnology. Topics include: intellectual property, privacy, government and industrial regulation, liability, ethics, and policy responses to societal concerns in the U.S. and abroad. Case studies involving gene therapy, cloning, and biomaterials in the medical and health sector, and farming and crop modification in the agricultural sector will be explored in detail.
For more information contact: exed@csuci.edu or click here 
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BIOL 516 Clinical Trials and Quality Assurance (Online)
An introduction to the foundational knowledge and skills necessary to successfully conduct clinical trials for new drugs, biologics, and medical devices, including in vitro diagnostics. Topics include a broad overview of the product development process in the pharmaceutical, biopharmaceutical, and medical device industries, the regulatory and operational requirements for clinical study setup and management, monitoring, data management, and closure of clinical trials, the principles of Good Clinical Practice (GCP), and the applications of quality control and quality assurance. The integration of quality assurance throughout the medical product development process will be discussed.
For more information contact: exed@csuci.edu or click here .
QAS 540 Food & Drug Law (Online)
This course is designed to provide a practical interpretation of the Food and Drug laws and interpretations for professionals who are providing products or services in industries regulated by the Food and Drug Administration.
For more information or to apply click here .
BIOL 7703 The Pharmaceutical, Biotechnology and Biodevice Industries (Online)
This course provides a general introduction and foundational knowledge to the pharmaceutical, biotechnology and biodevice industries.
You need this knowledge to support further study and eventual job performance as a regulatory affairs professional. The course will focus on company organization, product development, and commercialization-associated activities, such as drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control, marketing, and post-marketing surveillance.
For more information or to apply click here .
BIOL 7704 Introduction to Food and Drug Law (Online)
This course provides you with an overview of the laws governing development, manufacture and commercial distribution of drugs, biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical device industry. Issues covered include the US legal system; the Food, Drug and Cosmetic Act and related laws; the Freedom of Information Act; regulations affecting foods, cosmetics, drugs, biologics, veterinary products, devices and diagnostics; FDA enforcement; product liability, import/export requirements, orphan products and combination products.
For more information or to apply click here .
BIOL 7707 Post-Approval Activities, Including FDA Advertising, Promotion and Labeling (Online)
Learn about FDA and FTC rules and regulations governing advertising, promotion, and labeling for prescription drugs, biologics, medical devices, and over-the-counter drugs. Prerequisites: Introduction to Food and Drug Law (BIOL 7704).
For more information or to apply click here .
BIOL 7708 Investigational and Marketing Applications for Drugs, Biologics and Medical Devices (Online)
This course examines 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.
For more information or to apply click here .
BIOL 7709 International Medical Regulations (Online)
This course explores current international medical regulations in their current status in many key areas of the world helping students to gain an understanding of the changes brought about by multi-national projects due to cultural differences.
For more information or to apply click here .
BIOL 7711 Practical Ethics for Healthcare Professionals (Online)
This course examines the 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 will be presented. Students will develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.
For more information or to apply click here .
SECS 4912 Regulatory Affairs and Quality Assurance in the Pharmaceutical Industry (Online)
In this online class, you will learn how to meet the challenge of maintaining compliance with Federal regulations and the FDA's expectations. You will be introduced to Federal Regulation 21CFR211 and the Current Good Manufacturing Practices of Finished Pharmaceuticals with respect to drug manufacturing. Learn about the FDA perspective on regulations and guidance practices as well as current areas targeted by the FDA. Gain practical knowledge of GMP applications as related to real-world operations and quality issues as well as current FDA requirements.
For more information or to apply click here .
RA 696 Regulatory Affairs & Ethics (Online)
This course will provide foundational knowledge of the biotechnology, pharmaceutical and medical device industries, along with a comprehensive introduction to related regulatory affairs activities. The course will focus on the concept-to-market process for new drugs, biologics, and devices, along with the associated regulatory affairs roles of the company and the various regulatory agencies. An overview of related laws and regulations enforced by the US Food and Drug Administration (FDA) will be provided, with topics including the Food, Drug and Cosmetic Act; regulations affecting combination products, and diagnostics; and FDA enforcement. Current legal and ethical issues within these industries will be discussed, along with future trends.
For more information contact: (619) 594-3954, rbhathal@mail.sdsu.edu or visit the program webpage.
RA 601 Pharmaceutical, Biotechnology, and Medical Device Industries (Online)
This course will provide foundational knowledge of the biotechnology, pharmaceutical and medical device industries, along with a comprehensive introduction to related regulatory affairs activities. The course will focus on the concept-to-market process for new drugs, biologics, and devices, along with the associated regulatory affairs roles of the company and the various regulatory agencies. An overview of related laws and regulations enforced by the US Food and Drug Administration (FDA) will be provided, with topics including the Food, Drug and Cosmetic Act; regulations affecting combination products, and diagnostics; and FDA enforcement. Current legal and ethical issues within these industries will be discussed, along with future trends.
For more information contact:
extended.std@sdsu.edu or visit the College of Extended Studies website .
RA 602 Food and Drug Law (Online)
Laws governing drug, biological, and medical device products. Discussion of Federal Food, Drug, and Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.
For more information contact:
extended.std@sdsu.edu or visit the College of Extended Studies website .
RA 774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices (Online)
Development and informational content for investigational new drug applications (IND), investigational device exemptions (IDE), new drug applications (NDA), product license applications (PLA), and biologics license applications (BLA) for FDA review. (Offered only as a distance education course)
For more information contact:
extended.std@sdsu.edu or visit the College of Extended Studies website .
RA 775 Clinical Trials: Issues in Design, Conduct, and Evaluation (Online)
Issues and requirements in design, conduct, and evaluation of clinical trials for new drugs, biologics, and medical devices. Introduction to biostatistics. (Offered only as a distance education course)
For more information contact:
extended.std@sdsu.edu or visit the College of Extended Studies website .
RA 781 Ethics for Health Care Professionals (Online)
Ethical issues confronting health care professionals. Moral positions concerning impact on laboratory animals, human subjects, patients, and consumers, both on a case-specific level and as applied to field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice. (Offered only as a distance education course)
For more information contact:
extended.std@sdsu.edu or visit the College of Extended Studies website .
Introduction to the Clinical Trials Process
Drugs, biologics, and devices require structured clinical testing in humans prior to approval for marketing and post-marketing safety surveillance. This class provides an introduction to the clinical research industry including trends and opportunities, clinical program and trial development and management, regulations, ethics, and the role of regulatory agencies, sponsors, investigators, IRBs, and the public as study subjects or patients.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Good Clinical Practices
Good Clinical Practices are an established industry code for the structure and conduct of effective, ethical, and compliant clinical research studies. This class will review the scientific basis of clinical drug, biologics, and device research, the regulatory basis behind human trials, and the GCPs commonly accepted in clinical research across the US and globally. We will focus on application of GCPs in sponsor companies and clinical research study sites from recruitment and consent of subjects to audit requirements. Fluency in GCPs is essential toward optimal employability, and will serve you well over the course of your career.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Data Management
Today’s Clinical Trials depend on clean, fully integrated scientific databases, ready for statistical analysis and in full compliance with regulatory guidelines. This class teaches you to frame research questions accurately, in terms that work for the trial and for the database, to choose the most appropriate technology to capture and store the data, and to translate the data into terms understood by biotstatisticians and the analysis programs most commonly used.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Biostatistics in Clinical Trials
This course provides basic statistical concepts for the non-statistician involved in clinical trial design, implementation, and report writing. Topics include the role of the statistician, statistical terms, study designs, sampling techniques, hypotheses, endpoints, data management, and analysis plans.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Trials Monitoring
This course provides the foundation for monitoring clinical trials. Topics include roles and responsibilities of the sponsor and investigator site defined by the FDA and applied to monitoring activities from study start-up to completion. Study site selection, initiation, interim monitoring, and closeout procedures are reviewed. Regulatory documents, source documents, safety reporting of adverse events, study drug accountability, and compliance are reviewed. Principles of investigator grant budget, contract, and payment are also reviewed.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Trials Design
This course will provide students with basic understanding of clinical trials design, and will review techniques used to prevent potential bias that could impact the approval of a new drug to the market. Topics include Phase I to IV trials, project team roles, trial methodology, and regulatory requirements. Processes and components of protocol development will include synopsis, hypothesis, scientific rationale, study objectives, sample size, endpoints, procedures, safety, ethical considerations, and analyzing and reporting the results. Quality of life, pharmacoeconomics, management of clinical supplies, and new technology will also be discussed.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Operations: Study Start-Up
Drug companies lose on average more than $600,000 each day clinical trials are delayed. The need for clinical trials to be completed on time and within budget has never been greater. The Clinical Operations group is responsible for the planning, implementation and conduct of large, complex clinical trials or multiple smaller studies across indications or development compound(s). The Clinical Project Manager (CPM) is responsible for leading a cross-functional team to conduct a clinical trial according to its timeline, within a specified budget and define resources.
This class provides an overview of clinical operations in the study start-up phase of a clinical trial. From final protocol to first patient in, a team must be formed, vendors and sites selected and activated, processes established for data collection and reporting and regulatory approvals obtained.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Operations: Study Conduct
This class provides an overview of clinical operations in the study conduct phase of a clinical trial. Continuing where the Study Start-up class left off, we pick up with enrollment and continue through last patient out. We will explore strategies for keeping the study on-time and within budget despite recruitment challenges, protocol changes, data entry and cleaning efforts, safety events and team members coming and going.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Clinical Operations: Study Close-Out
This class provides an overview of clinical operations in the study closeout phase of a clinical trial. Continuing where the Study Conduct class left off, we pick up with data entry of the last patient visit and continue through development of the study report. We will explore strategies for keeping the study on-time and within budget despite data entry issues and cleaning problems, site and vendor closeout, database review and lock and development of the clinical study report.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Case Report Form Design
The case report form (CRF) is the primary data collection tool in clinical trial conduct, analysis, and reporting of results. The sponsor is responsible for development of a CRF that accurately represents the protocol, management of CRF production, monitoring, and auditing. The study site is responsible for accurate and timely completion of the CRF. This short course provides an overview of key elements in design and management of the CRF.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Adverse Events
An Adverse Event (AE) is any unfavorable symptom, sign, or disease (including an abnormal laboratory finding) temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An Adverse Event can also be the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product. In the pharmaceutical industry, Adverse Events are monitored and collected in clinical studies. All reported adverse event terms are coded using a standardized international terminology, MedDRA (the Medical Dictionary for Regulatory Activities). This course covers the history and guidelines of AE reporting.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Ethical and Legal Issues in Clinical Trials
This course will address ethical issues raised by the use of human subjects in clinical trials. Since IRB’s have the ultimate authority to decide whether a clinical trial meets ethical (and legal) standards, it is important for professionals who design and manage trial to understand how IRB’s deliberate and decide in order to facilitate interaction with them. Issues covered will include subject recruitment methods, the ethics of placebo-controlled trials, investigator conflicts of interest, research with minor subjects, and research with adult subjects who have impaired decision-making capacity.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the course website .
Regulatory Processes & Issues
The FDA and other regulatory agencies establish rules and guidances for clinical development and marketing of drugs, biologics, and devices. This course provides an overview of drug development and the regulatory process that is necessary to get drugs approved. The course will provide students with a good basic understanding of the regulations involved in drug development, how the technical areas (i.e., manufacturing, pre-clinical and clinical) interact during that development, and where to find information to guide that development. This class will include lectures, hands-on workshops and class presentations.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or click here .
Medical Devices
Regulation plays a key role in the design, development and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation.
This course provides an overview of the medical device industry, US and International regulations and the development of medical devices. In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines its regulatory pathway.
Through lectures and case studies, students will be introduced to the medical device development and approval process and learn about different strategic choices for marketing medical devices. Non-clinical and clinical testing of devices is reviewed, including the investigational device exemption (IDE) application process and the FDA quality systems regulations (QSR) for manufacturers. Marketing applications such as 510(k) exempt devices, special, abbreviated, and traditional pre-market notifications [510(k)s] and pre-market approval applications (PMAs) will be discussed. In vitro diagnostic devices (IVDs) and combination products are also briefly reviewed.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or click here .
