The FDA and all regulatory agencies use inspections and audits to ensure the quality of health care products worldwide, particularly in order to maintain standards when manufacturing is outsourced abroad. Audits determine if companies comply with regulations set out in the Food, Drug and Cosmetic Act in the US or comparable requirements in other countries. The regulations set out requirements for companies to conduct internal audits of their own manufacturing, storage and distribution activities, including areas such as adverse event reporting, customer complaint handling and recall procedures. Regulatory agencies also use audits to ensure that companies conducting animal studies (GLP) and/or human clinical trials (GCP) comply with regulatory requirements. Students will be introduced to all aspects of auditing during the development and manufacturing of drugs, devices, dietary supplements and biologics.
One of the pillars of quality assurance for devices, drugs and biologics, are manufacturing processes that are well-understood, consistent and highly controlled. A process is generally considered well-understood when (1) all critical sources of variability are identified and explained; (2) variability is managed by the process; and (3) product quality can be accurately predicted while accounting for materials, manufacturing, environmental, and other conditions. Statistical Process Control (SPC) is an industry-standard methodology for measuring and controlling quality during manufacturing. Students will acquire a strong understanding of process development and the use of statistics to maintain quality systems.
As the number of pharmaceuticals manufactured outside of the US increases, the FDA and other regulatory agencies must look at new ways to ensure their quality. Biologics are products derived from living sources including humans, animals and microorganisms. Biologics have seen significant international growth over the last few years. Since these products are synthesized from living organisms, ensuring the quality of biologics is especially complex. An essential tenet of regulatory oversight is the assurance of quality through post-marketing surveillance, internal audits and regulatory inspections. Students will learn about the regulations needed to ensure the quality of drugs and biologics in the US and internationally, and will gain an understanding of the principles necessary for the interpretation and implementation of a quality system.
In 1996 the FDA revised their existing Good Manufacturing Practice (cGMP) requirements for medical devices to incorporate a requirement that all medical device companies must implement a formal quality system. These new regulations included methods for designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. In the past 5 -10 years there has been a significant increase in developing combination products, which pair drugs/biologics with devices to achieve their intended use. Students will learn about the regulations and guidelines that ensure the quality of medical devices and combination products in the US and internationally, and the principles important for interpretation and implementation of a quality system, including QSR, ISO 13485 and ICH.
Are you interested in the way that the many regulatory agencies govern the development and commercialization of medical products? In this course, we examine the roles of a host of governmental bodies. By focusing on an unusual case-study, students will work in groups to identify how these many agencies overlap to oversee the production of medical and health-care products. Designed for students new to regulatory science, this course can serve as an overview for those who want a beginning flavor of the profession. Alternatively it can be a foundation for later courses in which particular aspects of medical product development are explored in detail.
Pharmaceuticals are amongst the most profitable of medical products. They are also one of the most demanding to commercialize and most subject to regulatory oversight. This course will explore the relationships between scientific discovery, testing and regulatory oversight. It will look at the rules governing prescription and over-the-counter drugs, and look at the changes that are introduced by the burgeoning influence of genetic engineering and biological product development. It will consider the practical issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and keep product approval.
Twenty years ago the bionic man was considered to be a science-fiction flight of fancy. Today, most people over the age of sixty will have at least one bionic part. Perhaps not surprisingly, new advances in science and engineering are changing the way that governments are looking at the regulation and payment for new medical technologies. This course will explore the developmental and regulatory path for new devices, and look at the way that products are governed once in the marketplace.
Globalization of the food supply and increased usage of dietary supplements imparts domestic and international demands on the regulations of these items such that the products are safe and the associated claims are truthful and not misleading. This course explores the regulatory dynamics of foods and their components, including intentional additives and possible contaminants, and dietary supplements, and examines the contentious nature of international regulations associated with these products. Experts share their expertise and address the current and future state of regulations that governed these products. Students experience the production and regulatory differences between foods and dietary supplements through field trips to production and manufacturing facilities of food products and dietary supplements, and critically review these differences through discussions, oral presentations, and written assessments.
If medical products fail, there can be life-threatening results. Quality assurance is a huge part of medical product development and constitutes a science in itself. In this introductory course, we will examine the way that different countries regulate the quality of medical products, from design and development to manufacturing and distribution. We will study the rules governing good laboratory and manufacturing practices, and explore how they mesh with ISO and European standards, CE marking and quality systems regulations. We will look at risk analysis and documentation, and participate in a real-life audit. Course requires a distance module to be completed by the last course date (allow two weeks minimum).
Laws governing medical products are the beginning point for regulations that identify how research, development and marketing of such products should be pursued. Almost every activity in the chain of product-development activities will have legal implications and liabilities. This course will explore the history of laws related to medical product development, commercialization and clinical use, and will consider relevant legal cases whose decisions have been important in establishing precedents and guiding interpretations of legal theory over the last two decades.
Clinical trials are big business. They underlie the commercialization of most new drugs and invasive medical devices, products with enormous capability to harm as well as help. Over the last few years, highly publicized problems have put clinical trials under a regulatory microscope. In this course we will look at the bioethical and practical concerns that shape the design of clinical trials. We will examine how trials are carried out, and how they are managed and documented. This innovative course is designed with practitioners in mind and focuses on more advanced concepts and problems presented by real-life clinical situations and challenges from experts in the field. The course requires three homework assignments, a midterm and a take-home final exam on the diverse topics covered in the course.
Written communication is so important for the work of regulatory and clinical professionals! In this course, we will review all of those rules for writing grammatically correct and stylistically compelling reports and submissions. We will examine in detail some of the tricky parts of submissions, and we will discuss time and project management skills needed to produce large multi-authored submissions to the FDA.
The marketplace for medical products is global. This advanced course in Regulatory Science is designed to compare the laws, regulations and institutions governing medical products in North America with those of several other countries and groups of countries. Particular attention will be paid to regulations that shape the developmental path and marketing applications for drugs, biologics, and medical devices. We will study the countries, including developing countries in which ethical considerations are often very important to understand.
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 core requirement prior to approval of clinical trials or product commercialization. The goal of this course is to introduce the student to the formal language, historical development and theoretical underpinnings of risk management. Several formal methodologies exist to characterize and manage risks in product design, manufacture and use in target populations. The goal of these approaches is to prevent problems by anticipating and mitigating them. However, risk management strategies also include activities related to risk control such as recalls, crisis management insurance and legal actions.
It is unknown how many promising compounds have been rejected because they were evaluated in a poorly designed study. Well-designed clinical trials are essential in the development process of a medication or device. Before developing and executing a clinical trial, essential features which must be considered include: 1) basic study design; 2) study population; 3) planned statistical analysis; 4) enrollment of subjects; 5) regulatory requirements; and 6) ethical issues. In this course the student will explore and become familiar with clinical research designs and statistical analyses utilized in medical-product research. The course will also highlight the unique features of clinical trials in specialized populations such as AIDS, cancer, pediatrics and psychiatry. Current trends for accelerating drug development will also be covered.
The importance of safe and “healthy foods” in today’s society has resulted in an expansion of food science and technology applications. The science and the technology continue to employ the basic concepts of food science and food safety. Those concepts include, but not limited to, fundamental food chemistry, food composition and nutrient interactions, food processing, food engineering, food stability and preservation, food sensory qualities, food toxicology, food microbiology, and food biotechnology. These concepts encompass a variety of physical principles, physiological processes, and regulatory guidelines, which contribute to the introduction of more stable, nutritious products to feed our growing population. Students will discuss these concepts and experience their principles through classroom demonstrations, personal local grocery market surveys, and group projects.
Drug and food safety is at the forefront of consumer concerns. The course examines the safety assessment of these products as the students develop a general understanding of the toxicological tools and regulations associated with drugs, botanicals and food components. The fundamental concepts of pharmacokinetics and absorption, distribution, metabolism and excretion (ADME) will be applied to historical and contemporary drug and food products. Students will develop critical thinking skills through discussions, critical problem-solving experiences, and case report analyses of drug and food components.
Chemistry, Manufacturing and Controls documentation reflect the scientific foundation for commercialization of new active pharmaceutical ingredients. The technical challenges coupled with the domestic and international regulatory dynamics place considerable demands on numerous key elements in the CMC process. Student experiences will develop a critical understanding of the CMC process and will craft essential CMC documents that encompass the breadth of this process. The details and demands of this process are presented and discussed by leaders from regulatory agencies, private industry, and academic institutions.
It seems as though newspapers run stories about hazardous food and medical products weekly! In this course, we focus on the role of the medical product manufacturer and supplier in the management of safety. We define the regulatory expectations and the best-practices used to meet these expectations. Some of these practical approaches anticipate problems before they happen, at the level of manufacturing, packaging and labeling. Other approaches include corrective and preventive actions that are stimulated by field observations, complaints and other forms of pharmacovigilance. Finally, we will study specific approaches for managing product records and archiving information and product that might be needed in case of legal challenge. Crisis management plans and recall procedures will be reviewed with a particular focus on the special challenges faced by medical product manufacturers. The course will include hands-on practice using vigilance application tools, and the MedDRA and Med Watch data bases.
Management of risk is a central part of quality assurance programs. Medical products are designed to ensure that they are safe and effective. Risk management is emerging as a core requirement prior to approval of clinical trials or product commercialization in a range of fields including foods and medical products. In this course, a cohesive set of risk management tools are introduced. Students with a basic knowledge of biomedical science and regulatory structures will explore in depth how to apply these tools. Emphasis will be placed on tools in common use in the engineering and medical products arena, including functional analysis, fault-tree analysis, failure modes and effects analysis, hazard analysis and critical control point analysis and six sigma methods.
Translational medicine is the continuum – often known as “bench to bedside” – by which the biomedical community takes a focused point of view to move research discoveries from the laboratory into clinical practice to diagnose and treat patients. This desire to see a rapid progression from laboratory bench to hospital bedside brings with it huge hurdles that must be addressed and overcome – technological, ethical and regulatory. Thus, this introductory course is designed to provide an overview of principles and concepts underlying drug discovery and development as seen through the eyes of the industry, including terminology of translational science.
Examines the process of drug discovery from selection of disease and therapeutic target to characterization and validation of lead drug candidates. Specific areas of interest are focused on steps related to target validation, genomics/bioinformatics, high-throughput screening, chemistry, pharmacokinetics and pharmacology. A subsection to this course will also cover an introduction to biopharmaceuticals, such as gene therapy and recombinant DNA technology. Moreover, the business aspects of bringing new drugs to the market will be discussed in the context of preclinical drug discovery as well as topics that companies must consider when involved in drug discovery and development, such as the financial aspects of starting up a pharmaceutical enterprise, the regulatory process, liability and litigation, and patent law.
Typically, during pharmaceutical drug development, large numbers of molecules are generated with the goal of identifying the most promising candidates for further development. This course explores the activities involved in transforming an early drug or biological candidate to a drug approved for marketing by regulatory authorities. Specific areas of interest will center on large-scale compound formulation and dosage criteria and extensive toxicity and pharmacokinetic studies in both animals and humans in preparation for either an exploratory IND or an IND application submission. Following the conclusion of the drug development phase, this course will outline the process of ensuring product for clinical trials and scaling up for subsequent NDA submission.
Clinical study of a new drug is predicated on the evaluation of drug safety. The purpose of this course is to provide a comprehensive understanding and utilization of safety pharmacology strategies that are mandated by the various regulatory bodies (e.g., Food and Drug Administration, European Medicines Agency, etc.) to move a new chemical entity (NCE) from the discovery stage to market approval. In addition, coursework and case studies will be presented in order to provide the students with a better understanding of the complexities and untold adverse drug events that have arisen due to some of the shortcomings in the required toxicology studies including unexpected drug-drug interactions, drug-disease specific interactions and drug-alcohol interactions.
This course provides an intense review of contemporary domestic and global food regulations, and introduces best applied practices within the food regulation network. The rich history of food regulations from 1906 to proposed statutes will be analyzed extensively. Modern topics, such as product labeling and health claims, forms of food adulteration, safety of food additives and coloring, emerging food processing technologies, specialized nutrition regulations that include infant formula and dietary supplements, as well as food terrorism and federal inspection and enforcement jurisdictions, plus international food law will challenge members of the industry and those with food regulations responsibilities and interests. These regulations illustrate the importance of bringing science and health expertise into a social context. They solidify knowledge appropriate for emerging career pathways at the intersection of food and dietary supplements and the dynamics of science and health.
A growing pharmaceutical company must be able to adapt to the evolving regulatory environment and sensitive to reimbursement requirements so that it can market the products effectively. It is critical to understand how the reimbursement process interplays with product differentiation and market penetration. In addition, it is essential to produce convincing health-outcome results as the foundation for strategic reimbursement schemes and successful market access. This class allows the audiences to understand the significance of involving payers early in the development phase and to develop strategies to work with FDA and CMS to ensure timely market entry.
Research leading to the master’s degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.
Regulated industries, such as medical product manufacturing, must adopt and adhere to complex compliance procedures to ensure their final product meets quality, safety and purity requirements so that it is safe for distribution and / or sale. As one of the essential pharmaceutical commercialization requirements, validation assures consistent reproduceable and repeatable results as part of the Quality Management System (QMS) for testing and manufacturing processes. In this course, we will follow the progression of the testing and manufacturing validation activities over time in the pharmaceutical industry, beginning with equipment qualification, computer system validation (CSV), cleaning validation, laboratory instruments, testing and methods validation, manufacturing process and environmental monitoring validation for accuracy and precision, security, reliability, consistency and productivity. You will see how business concepts merge with project management and science, to assure and keep products safe and in compliance with applicable regulations.
Introduction to business principles appropriate to medical products, including: supply and demand, product entry-exit strategies, financing, reimbursement, marketing and pricing in global marketplace. Students will be able to interact with experts in sales, marketing, new product development and strategic intelligence to see how these various elements influence the business decisions needed as a new product moves from the bench to the market and into obsolescence. This transitional course will use a mix of distance and site-based delivery systems. Each site-based session will be an intensive day-long session, after which will be assigned about 3-4 streamed lectures to add other perspectives to the course. The output of the course will include a business plan and a number of smaller assignments.
Recent advances in science and medicine have raised a plethora of issues concerning science, research and ethics. In this course, we will review the traditional approaches and concepts that underlie bioethical analysis. Using case studies, we will consider some of the major ethical issues facing basic scientists and clinical researchers. We will then expand our considerations to issues of financial management and conflict of interest, of product liability and managed care. The first day of the course will be more didactic. The last three days will center on student projects in each of several areas.
Project management is central to the efficient, effective conduct of complex organization. In this course, we will evaluate some of the tools and methodologies that provide a common approach and language for product managers in a range of disciplines. We will then look at some of the particular challenges inherent to products in the medical products sector, including the need to manage innovation and scientific enterprise, the challenges of multifunctional teams that cross into clinical environments, the highly transnational nature of some projects and the implications of intellectual property and privacy concerns. Finally, we will study specific approaches for managing product records and archiving information that might be needed in case of legal challenge. Crisis management plans and recall procedures will be reviewed with a particular focus on the special challenges faced by medical product manufacturers. The course will include hands-on practice using project management methods.
Are regulatory standards developed and applied in different constituencies in Asia? At the beginning of the course, we will study in depth the regulatory rules and business climate in countries that differ markedly in their levels of development, regulatory maturity and socioeconomic features. Students will develop briefing packages on the different countries for the use of their colleagues. We will then travel to a subset of Asian countries as a delegation. By meeting with the principal regulatory authorities in each country we will have a first-hand opportunity to study the interplay between culture, management methods and regulatory expectations. We will then visit “typical” domestic and foreign medical-products companies to investigate what they see as the major challenges in medical product development and commercialization. We will explore how regulatory expectations affect principles and practices in the delivery of health care and the expectations of society. We will also examine the stresses that are occurring in these rapidly evolving business environments, and consider approaches and solutions to working with Asian manufacturers and distributors.
The objective of this course is to study the way that people are organized and managed in organizations of different types and sizes. The course will focus first on management principles in general. We will consider the theoretical underpinnings of personnel management, organizational design and industrial relations. We will then bring that theoretical knowledge into practical situations, using case studies, discussions and role-playing. As part of this course, we will focus on management styles, leadership and negotiation capabilities. Particular attention will be paid to two types of very different organizations, the small, rapidly growing enterprise and the large, mature company with extensive global operations. Such organizations best typify the medical products industry.
Within the pharmaceutical industry, many products are being introduced that no longer fit the common notion of a synthetic drug. Biological products, cell-based therapies, products using nanotechnology or radiochemicals, all present new regulatory challenges. Students will analyze current policies and guidelines under which such complex products are developed and regulated. The class will explore trends in policy development and the differences in regulatory requirements for complex biologics, stem cells, products using nanotechnology or radiolabels, whole organ transplants and blood. Students will learn about the documentation needed to gain new product approval, to maintain product surveillance and to withdraw products from the market when necessary.
This course will provide an overall step-by-step process from selection of a research project to its successful conduct and documentation. Specific areas of interest that are especially appropriate to the medical products field are ethical and tactical considerations of informed consent, privacy protection and conflict of interest. Research design structures with a particular focus on clinical, epidemiological and social science methods that students will be using for their thesis research will be analyzed in depth. Concepts of validity and interpretation will be underscored.
The purpose of this course is to acquaint students with the way in which regulations, laws, culture and business climate combine to affect the competitiveness and business environment for medical products in the EU, Canada and South America. The course builds upon a basic understanding of global regulations. Through both focused lectures and later travel to both EU and Canada, students will have the opportunity to talk to representatives of principal policy and rule-making bodies of the European commission and the individual countries themselves. We will study the way that regulations differ from elsewhere in the world and we will further study the differences that exist between the way that foods, drugs and devices are managed in Europe, Canada and South America.
“Book-learning” is important but equally important is the application of learned principles to the management of real-life regulatory, quality and clinical problems. For students without previous background in the field, an internship period in industry is offered during which trainees work alongside other professionals in industry and government. These internships are arranged with the help of the School of Pharmacy, and in consideration of the future career interests of the individual trainee. If trainees have already ideas about sites in which they wish to spend this period they should identify these interests early. In addition, individuals already in industry may be interested in conducting a research project in their home institution. We encourage such activities, but the arrangements must be approved before formally registering in the course.