17 courses:
  • RA-601

    Overview Med.Product Industry

    This overview of the industry is intended to provide a common basic level of understanding, whether the student comes directly from an undergraduate program, another graduate program, or from industry experience in limited types of products or associate activities. It includes: -the medical product industry (pharmaceutical, biotechnology, and devices) typical company structures laws, regulations, and standards -the government structures, agencies, organizations, and societies that influence and produce them -regulatory agencies that enforce them -third-party organizations (product testing, quality system auditing, and/or clinical research organizations) the healthcare industry (providers, such as hospitals and clinics, and other health-related entities such as insurance companies, HMOs, and government health plans)
  • RA-602

    Overview of FDA Regulation

    This overview course covers general elements of the Food and Drug Administration (FDA) and the nature of the industries regulated. The course provides a fundamental understanding of the organization and structure of the FDA; conveys a fundamental knowledge of the tools that the FDA uses to regulate the drug, biologics, and device industries by investigating the process that brings drugs, biologics, or devices to the market place; and provides a general knowledge of post marketing regulatory obligations of manufacturers, distributors and prescribers of health products that keep the products on the market and promote public health.
  • RA-602A

    Overview FDA Regulation

    This overview of the Food and Drug and Cosmetic Act describes the basis for FDA regulation of the development, production, and the approval processes for drugs, devices, biologics, foods, and cosmetics.
  • RA-603A

    Pharmaceutical Prod Regul

    This overview course covers general elements of the Food and Drug Administration (FDA) and the nature of the industries regulated. The course provides a fundamental understanding of the organization and structure of the FDA; conveys a fundamental knowledge of the tools that the FDA uses to regulate the drug, biologics, and device industries by investigating the process that brings drugs, biologics, or devices to the marketplace; and provides a general knowledge of post marketing regulatory obligations of manufacturers, distributors and prescribers of health products that keep the products on the market and promote public health. Prerequisites: RA 601 and RA 602ARA
  • RA-604A

    Medical Device Regulation

    This course includes a survey of the principles of medical device regulation focused on the regulations of the United States, the European Union, and Canada. Students select a hypothetical product as a semester-long project and apply what they learn about each of the issues covered, including classification, quality systems, design controls, standards, software, biocompatibility, infection control and sterilization, production control, and post market activities. Prerequisites: RA 601 and RA 602A
  • RA-605

    Field Experience-RegulAffairs

    This course consists of a coordinated field experience at a biotechnology company or research organization. Students will apply the principles learned in classes to produce results of value to the host organization. The experience can occur where the student is employed or at organizations found by the student. Faculty and fellow students can help identify appropriate sites and projects. Project locations and the nature of the experience must be approved by the Regis faculty and by the host organization. Prerequisites: Courses appropriate to the project as determined by faculty advisor
  • RA-608

    Clinical Research Methods

    This course offers an introduction to common clinical research and analytical methodologies used in device and pharmaceutical product development. Specific topics include proof of concept and technology development surrounding device feasibility studies, exploration of new applications, indications and modification methods, and safety and effectiveness. Also included are human factors engineering, medical personnel usability, and over-the-counter, home-use, or direct-to-consumer products demonstration of clinical value, and qualifications for reimbursement. The student learns the specific methods for different products and applications, such as, pharmaceuticals, biologics processing (e.g., blood processing), in vitro diagnostics, clinical laboratory instruments, and monitoring, diagnostic, therapeutic, or preventive devices. Factors in the design of clinical research methods include: -statistical methods and power analysis, quantitative versus qualitative methods protocol design, and inclusion/exclusion criteria -selection of study sites and investigators, including the choice of foreign or domestic sites -regulatory and ethical restrictions Prerequisites: RA 601 and RA 602A. It is recommended that RA 609 be taken before RA 608.
  • RA-609

    Clinical Trial Management

    This course provides an introduction to the fundamentals of clinical trials, including The Code of Federal Regulations as they pertain to clinical trials, the role of the FDA, basics of drug and medical device trials, the FDA submission process, good clinical practices, institutional review boards, managing and monitoring clinical trials, and ethical principles including informed consent and conflict of interest. Prerequisites: RA 601 and RA 602A
  • RA-615

    Qual Systems & Risk Mgmt

    The student learns requirements and industry practice associated with the Medical Device Quality System Regulation, pharmaceutical Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, and associated international standards. Principles of quality system auditing will be studied and practiced in role-playing case studies. The principles of risk management and related regulations and standards are also taught and exercised in case studies. Risk management is applied to situations throughout the product life cycle. This course uses economic analysis to help understand the economic and financial problems now confronting our healthcare system. Considerable attention will be given to topics of current public concern including rapidly increasing costs, Medicare and Medicaid, excess capacity, expensive new technologies, national health insurance, and the problem of the uninsured. Prerequisites: RA 601 and RA 602A
  • RA-616

    Project Management

    This course will cover project management terminology, key concepts, and ideas for planning and scheduling projects including assessment and management of project time, cost, scope, risk, and quality. The role of an effective project leader is a demanding one that requires a clear understanding of the five project processes: initiating, planning, executing, controlling, and closing. Effective project management and its concurrent need to establish defined scope, within budget and completion dates is key to success in today's dynamic biotech, pharmaceutical, and healthcare environments. Core principles and fundamentals will be covered, illustrating interpretation and application of such requirements: -The Project Life Cycle: Initiating, Planning, Executing, and Closing Projects Recognition of Project Management Tools and Templates -Scope (Project Charter), Time (Work Breakdown Structure), and Financial Management (Budget) -Defining Roles and Responsibilities -The Importance of Team Building and Teamwork -Team Dynamics, Risk Assessment, Lessons Learned and Process Improvement -Managing Client/Vendor Relationships
  • RA-630

    Combination Products

    In this interactive course, participants are exposed to examples of combination products on the market, under development, and on the drawing board. The course concludes with a look at the future of medicine including tissue engineering and nanotechnology. (A basic knowledge of device and pharmaceutical product regulation is highly recommended. RA 603A and RA 604A can produce this understanding.)