Description: This industry overview provides a basic level of industry, whether the student come directly from an undergraduate program, from another graduate program, or from industry. Virtual Classroom capability.HYBRID
Description: 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.
Description: Required Textbook: Fundamentals of U.S. Regulatory Affairs, Seventh ed., RAPS, 2011 This overview describes the basis for FDA regulation of the development, production, and approval processes for drugs, devices, biologics, foods, and cosmetics. Virtual Classroom capability.
Description: This course presents an overview of the drug development process including issues related to preclinical, clinical and post-marketing activities. Special topics will be highlighted including a presentation on Personalized Medicine.Prerequisites: RA 601 & RA 602A
Description: A survey of the principles of medical device regulation focused on the regulations of the United States, the European Union, and Canada. 13/Summer:12 week course. Virtual classroom capability.
Description: A coordinated field experience at a product company or clinical research organization. Students 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. Assistance from 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. Contact Graduate Director for details.
Description: An introduction to common clinical research and analysis methods used in product development. The student learns methods for various products and medical applications. Prerequisites are RA 601 and RA 602A. Virtual Classroom capability
Description: 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, FDA submission process, Good Clinical Practices, Institutional Review Boards, managing and monitoring clinical trials, and ethical principles including informed consent and conflict of interest. 12 week course. Prerequisies: RA 601 and RA 602A or Instructor permission
Description: The student learns requirements and industry practice for the medical device Quality System Regulation, pharmaceutical Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice and associated standards. Principles of risk management are taught and applied in case studies. Prerequisites are RA 601 and RA 602A. Virtual Classroom capability
Description: The students learn project management terminology, key concepts, and ideas for planning and scheduling projects; assess projects, manage cost, time, scope, risk, and quality of projects. 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. 15/S1&S2:12 Weeks 5/18-8/8.
Description: Virtual Classroom Avaialable 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, nanotechnology.Current medical products, no matter how well designed, can only do so much to address many of the clinical problems today. To tackle the clinical problems of the future, combination products, medical devices used in combination with drugs and biologics, will be used to treat a wide range of diseases. The best-known example of a combination product, the drug-eluting stent, is a primitive example of a combination product. Quintessential examples are tissue-engineered products. They are composed of cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).HYBRID 13/FA :21,28 11/4 14/SP:2/22,3/1,3/15,3/22
Description: Medical products companies are subject to audits from regulatory and certification agencies and are required to have an internal audit program. This course describes the types of audits and the basic skills of auditing. Knowledge of quality system regulations and standards is covered briefly on-line. The course focuses on professional characteristics and skills of a lead auditor. Virtual classroom capability. 14/SP: 3/29,4/5,4/12,4/26
Description: This course introduces the student to the basics of global regulations for medical devices and in vitro diagnostic (IVD) reagents. Subjects include product registration, quality systems, manufacturing and distribution licenses, and post-market surveillance regulations. The course will discuss the strategy issues and regulatory pathways to bring a medical device to market in Asia, Europe, Canada, and Australia; in accordance with global harmonization. Virtual Classroom available HYBRID