Course Descriptions

• The Structure, Process and Outcomes of Regulation
  
  This course describes the basis of government regulatory authority, including state and federal administrative agencies, state legislatures and the United States Congress, and the role of the courts in interpreting and applying laws. The focus of the course in on the connection between outcomes of patient care and the structures and processes that are required by regulation of those who provide care to patients. The content of the course emphasizes the pharmaceutical product and medical devices, reviewing cases in which harm has been done to patients from these products, and considering how appropriate regulation could prevent this harm without adversely affecting patient care.



• Federal Regulation of Drugs and Pharmacy
  
  This course reviews federal Food and Drug Administration theory and practice, with a particular emphasis on product labeling requirements and the new drug approval process. The course reviews the requirements for preclinical studies, the three phases of clinical investigation, and the conduct of postmarketing surveillance.  IND and IDE requirements are studies. The “substantial evidence” necessary to support approval of a NDA, ANDA and SNDA are explored.



• The Use and Abuse of Statistics
  
  This course reviews statistical methods used to make inferences about data obtained in clinical trials. It demonstrates how statistics are used to rule out the possibility that the conclusions of a research project are the result of chance. Potential problems in the use of statistics are reviewed. The course examines published research articles reporting results that are not supported by the statistical tools used in the described study. The student is taught how to engage in critical analysis of the statistics in a proposed scientific study.



• Research Methods
  
  The conduct of scientific inquiry is taught in the course. From the moment at which an investigator has an idea about a potential breakthrough therapy, to the publication and defense of research results, this course describes how to formulate a research problem, develop and formalize hypotheses, collect relevant data, analyze the data, and critically interpret the results. The randomized, controlled clinical trial is the focus of this course, although quasi-experimental methods are also reviewed. Students are taught to critically evaluate proposed research projects.



• Ethics of Drug Production, Distribution and Use
  
  This is an introduction to biomedical ethics primarily as applied to pharmaceutical and medical device products. Subject areas include the provider-patient relationship, clinical research ethics, distribution of scarce resources, ethics and industry, and beginning and end of life issues. Topics of special interest are tissue engineering and stem cells, human cloning, xenotransplantation, defining diseases, genetic testing, and genomically customized medications.



• The Regulation of Clinical Research
  
  The relatively short history of federal regulation of research is discussed in this class. The “common rule” comprised of sections of federal regulations relating to human subjects research is thoroughly studied, including the distinction between research and innovative therapy, the requirement for informed consent, and the avoidance of conflict of interest. Research regulation by litigation is also studied through a review of legal cases that have applied federal criteria for clinical research. The process for developing risk management strategies for the appropriate supervision of research is reviewed.



• Research Ethics
  
  This is an in-depth examination of core concepts such as fairness in subject selection, minimization of risk, value, alternate means of acquiring new knowledge, informed consent and conflict of interest. The focus of the course is on the responsibility of the research team and institution to the research subjects. The course reviews the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. Analysis of the Tuskegee Syphilis study and the Willowbrook State Hospital study are conducted. The roles of the principal investigator and study coordinator are examined. The relationship between the sponsor and the investigators is scrutinized. Students are taught to critically evaluate the ethical component of a proposed study.



• Pharmaceutical Products and Public Policy
  
  In this course, students are challenged to consider the broader context of the research activities in which they will engage. Channels of distribution for pharmaceutical and medical device products are reviewed. The importance of intellectual property protection is discussed. The concept of comparative effectiveness is introduced. Pharmaceutical industry promotional practices, and the effect of them on research and clinical care, are examined. The global implications of domestic pharmaceutical policies are considered.



• Practices and Procedures of the IRB
  
  This course describes the nuts and bolts of how Institutional Review Boards operate. Topics discussed include IRB membership, IRB authority, criteria for IRB approval of research or exemption from review, and suspension or termination of IRB approval of research. The process of risk/benefit decision making is reviewed. The constituencies served by the IRB are examined. Current issues in IRB practice are discussed. Practical information about the week-to-week management of an IRB is explained.



• Pharmaceutical Outcomes and Policy Seminar
  
  This is a two-day exploration of a specific topic facilitated by an expert on the topic. Students are required to prepare for seminar by reading a book or a series of articles. Topics might be related to a recent widely publicized breach of research ethics, a newly released Institute of Medicine recommendation, or a basic area of interest such as fetal protection or Current Good Tissue Practices.



• Pharmaceutical Microeconomics
  
  This course will introduce students to basic microeconomic principles as they are applied to pharmaceuticals. Elucidation of the basic concepts of choice, opportunity costs, supply and demand, elasticity, utility maximizing behavior, competition, monopolies and oligopolies in the healthcare market will engage students and provide the foundation for success in the program.



• Health Economics
  
  This course will build on Pharmaceutical Microeconomics by delving into the economic principles and issues of health care in the US. Topics such as health care structure and financing, market failures, human capital, and producer and consumer behavior will round out the students’ understanding of the economics of our health care system.



• Evidence-Based Medicine
  
  This course will focus on building the skills necessary to incorporate timely and rigorously analyzed medical and pharmacoeconomic literature into a rational decision making process. Students will develop the ability to critically evaluate studies published in the medical and pharmacoeconomic literature, interpret statistics commonly encountered in clinical studies, and review strategies to efficiently and effectively retrieve drug information.



• Advanced Pharmacoeconomics
  
  This course will also build on Pharmaceutical Microeconomics by investigating the theory, methods, and application of technology assessment in health care. It covers basic methods used to structure a technology assessment study, measure and summarize health outcomes, estimate their value to patients or the public, identify the resources used, estimate cost of health resources, and construct and test mathematical models to make population and/or temporal predictions of outcomes and costs from limited data. Applications will be drawn from a variety of health care settings and will include the evaluation of pharmaceuticals.



• Regulating Pharmaceutical Access and Cost
  
  This course explores regulation intended to expand access to and control the costs of health care. Students are exposed to a variety of concepts including: the obligation to provide care; state and federal regulation of private health insurance and managed care; the implications of EMTALA, ERISA, HIPAA, and COBRA; Medicare and Medicaid; technology assessment; and drug pricing and controls.



• Health Care Systems
  
  This course will explore the structure and management of different mechanisms for organizing and delivering health care in the US. Students will develop an understanding of the implicit and explicit incentives for providers, patients, and payers in each system, and the impact of these incentives on the clinical, economic, and humanistic outcomes produced by the healthcare system.



• Pharmacoepidemiology
  
  This course will expose students to the traditional techniques used in descriptive and analytic epidemiology to describe and measure the negative impact of medication use. Students will learn how to use pharmacoepidemiology concepts, such as pharmacovigilance, to minimize patients’ risk exposure.



• Federal Regulation of Controlled Substances
  
  The Federal Controlled Substances Act, regulations promulgated by the Drug Enforcement Administration, and judicial interpretations of controversies in this area. The "closed-system" of controlled substance distribution created under federal law. Federal restrictions on the manufacture, distribution and use of drugs that are subject to abuse. Treatment programs for the disease of addiction.



• State Regulation of Drugs & Pharmacy
  
  Licensure and standards setting for health care professions and practice sites. Determination of initial and continuing competence of practitioners. Regulatory responses to professional misconduct. The role of professional self-regulation. Federal initiatives to regulate healthcare professionals and practice sites. The role of non-governmental organizations in practice regulation. Consumerism and state regulation.
  
  

• Regulating Drug Production, Distribution & Use
  
  Regulations that expand or restrict access to pharmaceuticals and that increase or decrease costs are reviewed in this course.  The course also reviews the obligation to provide care as well as state and federal regulation of private health insurance and managed care.  The implications of EMTALA, ERISA, HIPAA and COBRA are discussed.  There is an introduction to Medicare and Medicaid.  The course also reviews technology assessment, drug pricing, and price controls.
  
  

• Medicare & Medicaid
  
  The relatively short history of federal regulation of research is discussed in this class.  The “common rule” comprised of sections of federal regulations relating to human subjects research is thoroughly studied, including the distinction between research and innovative therapy, the requirement for informed consent, and the avoidance of conflict of interest.  Research regulation by litigation is also studied through a review of legal cases that have applied federal criteria for clinical research.  The process for developing risk management strategies for the appropriate supervision of research is reviewed.
  
  

• Practices & Procedures of Administrative Agencies
  
  This course describes the history of the FDA and CMS.  Agency organization and responsibility is explained.  Administrative practices and procedures are described, including formal and informal rulemaking.  The course discusses the interaction of federal agencies with state regulators.  It also discusses how to use regulation as a means to stimulate innovation.  In this course, relationships between agencies and Congress, other agencies, providers and recipients of benefits are discussed.  The course reviews how standards can be set through conditions of participation and the politics within the FDA and CMS.
  
  

• Health Care Risk Management
  
  This course provides an introduction to the concept of risk management in healthcare settings. The course will provide a historical perspective on the development of health care risk management, the role of the health care risk manager, the principles of health care risk management and the connection between risk management, quality improvement and corporate compliance in various health care settings.
  
  

• Law, Health Care and Patient Safety
  
  This course will provide an overview of patient safety theory, the scope of medical errors, and new emerging guidelines and strategies to leverage patient safety concepts, reduce errors and improve patient safety.
  
  
  
• Risk Management, Liability and Compliance
  
  This course will provide instruction related to applicable standards of health care risk management, including the principles of malpractice and insurance, the conduct of malpractice litigation, and the settlement of malpractice claims. Topics presented in this class also include: documentation in the medical record, risk exposures related to contracts and request for proposals, and emerging liabilities facing health care organizations.
  
  
  
• Patient Responsibility in Health Care
  
  This course examines the ways in which patients can accept responsibility for promoting good outcomes of the therapeutic modalities that the health care professionals and institutions provide. The focus is on how patients can foster a productive relationship with health care providers and institutions, and how they can participate actively in efforts to prevent failures of quality in the provision of health care.