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 14/SP 1/21-4/29. In class meeting dates 1/21,28 2/4,11,25 3/11,18 4/1,15,22
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 15/S1&S2:12 Weeks 5/18-8/8.
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. 15/S1&S2:12 Weeks 5/18-8/8.
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.