MPTX 520: Risk Management for Health Care Products

Instructors: Tony Chan, BEng, MEng, MBA, Guidant
Frances Richmond PhD, School of Pharmacy, USC
Additional speakers to be named

Course weight: 3 credits

Placement: Spring 2003 Orange County campus

Recommended Preparation:

Undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science) or permission of instructor

Introduction and Purposes:

Medical products are amongst the most highly regulated commodities on the market today because many can pose large potential risks to human health. Management of risk is a central part of quality assurance programs that are designed to ensure that products are safe and effective. Recent regulations in most developed countries insist on risk assessment and plans for risk management as a central requirement prior to approval of clinical trials or product commercialization. In this course, requirements for risk management will be explored. Several formal methodologies exist to characterize and manage risks in product design, manufacture and use in target populations. Students with a basic knowledge of biomedical science and regulatory structures will explore in depth some of these methods, including failure modes and effects analysis, fault-tree analysis, human factors analysis and hazards and critical control points analysis. When the course is over, students should understand not only the methods available for analysis but also the situations in which different methods will be most helpful. They should be able to integrate this knowledge with scientific principles related to the development of experimental protocols and testing paradigms, in order to plan and manage complex research programs. They should also understand the risks associated with product failures, including the legal consequences of product liability, and the approaches that can be helpful in reducing loss and controlling liability.

Some of the knowledge and skills developed by the student should include the ability to:
- Identify where and when risk analysis is required by regulatory authorities
- Implement a failure modes and effects analysis or fault tree analysis in product design
- Understand engineering approaches for assuring product safety and quality
- Understand the emerging trend in risk management in the US and Europe
- Design a human factors testing plan for an assigned device
- Develop a strategy for evaluating risk associated with a newly marketed drug
- Identify the strengths and limitations of Hazard Analysis and Critical Control Point (HACCP) and Hazard and Operability Study (HAZOP)
- Organize an audit of insurance needs for a clinical trial
- Compare a situation in which a potential problem of product liability was well handled with one that was badly handled
- Describe the requirements for post-marketing surveillance and adverse event reporting

Some parts of the course will be taught through case studies presented by the students. An emphasis will be placed on relatively informal lecture formats in which students are encouraged to ask and answer questions throughout the didactic sessions. As part of a novel strategy to meet the needs of part-time as well as full-time students, the course will be taught in a condensed period of full days and evenings totaling 40 face-to-face hours.

Course Requirements and Grades:

Midterm test 20%
Final examination 50%
Case study 30%
At the end of the course students should be able to demonstrate a competent knowledge of the subject matter as appraised by formal examination. In addition, students will be assigned to teams. Each team will be assigned a case study in which an appropriate research or testing plan must be developed for a medical device or in vitro diagnostic. The research plan will be submitted as a paper and a brief class presentation.

The research paper will be evaluated on the basis of the following criteria:
• Clear introduction of the problem to be solved
• Review of current guidelines and identification of regulatory requirements
• Identification of other issues that affect testing plan
• Specification of testing or research protocol
• Identification of potential problems or biases that cannot be eliminated
• Timeline and budget for the research or testing plan

Course Textbook

Glickman, TS (1991) Readings in Risk. Johns Hopkins University Press.

The textbook will be supplemented by a list of readings that will compliment the text. In some cases in which the reading is necessary to cover topics outside of the scope of the text, materials will be available in hand-outs.

Reader, containing handouts, selected journal articles and news clippings

Attendance and Conduct:

The Student Handbook, SCampus and University Catalogue provide guidance regarding academic policies and procedures. Students should regard the program as a part of their professional development in which courtesy and responsibility are significant factors in success. Thus, students are expected to communicate absences from class and are expected to attend all examinations and class presentations. Under normal circumstances, papers and exams must be submitted on or before the scheduled deadlines. Failure to make appropriate arrangements in case of justifiable delay will result in a penalty of 10% in the assigned mark for the first two weeks of delay, and further penalties for additional unapproved delays.

Textbook References and Additional Readings:

N.B. Reference texts and links are not updated regularly.