| Title | Winter | Spring | Summer | Fall |
| Regulatory Affairs |
Medical Product Marketing (3.00 Units)
MGMT X445
Getting your medical product to market successfully starts before product design and does not end with the product launch. This course focuses on what is needed to successfully market products within medical device and related industries. Learn how to analyze the market, identify and understand customers and users in medical marketing industries, and provide them with value through innovation, sales and service. Case studies and insights from practicing medical product professionals enhance the application of classroom concepts.
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to be scheduled
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Online
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Application of Good Clinical Practices (3.00 Units)
MED X413.4
Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research engagement; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.
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to be scheduled
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Biomedical Business and Legal Management Essentials (3.00 Units)
BME X414
Increase your knowledge of business and legal issues in the biomedical industry. Participants will learn to discern the rationale behind policies and procedures in a highly regulated industry. A top down approach is taken to introduce broad business and legal concepts and relating them specifically to design, development, and commercialization of medical device and pharmaceutical products. Topics include: corporate structure, corporate formation; and early stage financing, contracts, licensing, formation, intellectual property, due diligence and sale.
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Online
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| Quality and Compliance |
Medical Product Manufacturing (3.00 Units)
EECS X445.22
Learn about the essential manufacturing principles for medical device and pharmaceutical products, and the regulations governing the medical product manufacturing process. Gain valuable knowledge in understanding the key principles, challenges and issues involved in good manufacturing practices (GMPs) of medical products. Topics include: product development cycle, understanding the customer and their needs, material and process selection, packaging and sterilization, reliability testing, design validation, manufacturing process validation, and developing a manufacturing strategy.
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to be scheduled
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Process Validation for Medical Product Development (3.00 Units)
BME X407
Enhance your understanding of process validation and how it is applied to the development of medical products. Learn how to assess an appropriate level of process scrutiny to provide a high level of confidence for process validation. Increase your knowledge of validation project management; basic approach to process validation; validation criteria for facilities and utilities; sterilization; controls, automated processes, and computer systems. Case studies illustrate how critical processes are validated in the development of cardiovascular, ophthalmic, and intravenous devices.
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Medical Device Risk Management (3.00 Units)
BME X406
Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management.
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Online
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Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.
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Online
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to be scheduled
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Good Laboratory Practices (1.50 Units)
MED X413.41
Increase your understanding of the processes of application and compliance with FDA's Good Laboratory Practice (GLP) regulations for the conduct of animal/in-vitro (non-clinical) safety studies. Learn about sponsor obligations and important considerations to evaluate a contract laboratory. Develop new insights into topics that include: the applicable regulations from the Code of Federal Regulations (CFRs), and their history, typical methods of compliance, process of GLP integration into the drug/device/biologic development process, ethics pertaining to animal care and use, applicable Quality Assurance (QA) and Quality Control (QA) processes, GLP documentation management, and the FDA's GLP Inspection program. Gain an overview of the changing scope of the GLP regulations as well as its impact on biomedical research, and the future trends.
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Online
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| Engineering and Science |
Applied Anatomy and Physiology for Clinical Studies (4.00 Units)
BME X405
Whether designing investigational drugs and medical devices or conducting clinical trials, it is important to have a basic understanding of the form and function of the human body. Learn about human anatomy and physiology as related to pharmaceuticals and medical device design for clinical studies. Clinical examples and modeling techniques are used to demonstrate the applications of anatomy and physiology in the development of investigational drugs and medical devices. Course focus is on human safety in clinical studies.
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Online
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Medical Device Design and Evaluation (3.00 Units)
EECS X445.23
Explore the opportunities and need for medical devices through the examination of mortality and morbidity with special attention to medical problems that affect patients' productivity. A market and need-driven systems engineering approach is applied to the examination of medical device design. The designs of medical devices are then studied through a layered approach of examining the underlying physiological mechanisms, the applicable biomedical sensors and actuators as well as the control processing power requirements. Exemplary medical device solutions are studied.
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to be scheduled
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| Also of Interest |
Clinical Trials Internship (3.00 Units)
MED X413.44
Gain a working knowledge of the clinical trial researcher's role through an internship position. Within the internship, interns will get an opportunity to work in a Clinical Research setting of their choice for a minimum of 60 hours. During the internship one must keep a record of their hours and tasks. At the end the intern will submit a report of their internship experience based on their daily log kept throughout the internship and how their experience connected back to their core courses. The interaction that the intern experiences can be delivered through practical interactions with patients, coordinators, physicians, and regulatory affairs specialists. Students will be paired with a clinical research coordinator at their site location during the entire internship to acquire skills in clinical research management and regulatory affairs. There campus coordinator will be responsible for reviewing their hours and grading their final paper. To obtain more information about the internship please email Jennifer Mortensen at j.mortensen@uci.edu for course requirements and approval process.
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