MS in Biotechnology Innovation & Regulatory Science (Hybrid)

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Course Offerings

The MS in Biotechnology Innovation & Regulatory Science consists of four semesters (fall, spring, fall, spring) with one on-campus weekend each semester and ongoing faculty contact through distance-learning tools. You can complete your degree in just 22 months while balancing your professional and personal commitments.

Required Courses

  • Directed Projects: Projects are developed and approved with faculty and in collaboration with your Supervisor. Emphasis on process/continuous improvement. Deliverables include a written report (15-25 pages) and an oral presentation for approval. 
  • Drug Development: A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents. (3 credits)
  • Good Regulatory Practices: Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, and good clinical practices. The meaning of these regulations, the globalization of practices, and the roles and responsibilities of various professionals implementing these regulations are addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company. (3 credits)
  • Foundations of Research in BIRS (3 credits)

Elective Course Options

  • Documents and Dialogues of Drug Development and Registration: This capstone advanced course will integrate previous learning relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for preclinical research clinical trials and new drug approvals. Special topic lectures will be given. Considerable time will be devoted to preparing regulatory documents and conducting "mock" dialogues and negotiations with "pretend" agency officials. (3 credits)
  • Leadership in Biotechnology:  (3 credits)
  • Global Supply Chain Management: The objective of this course is to provide in-depth knowledge of global supply chain management and its application in industries. This course explores supply chain management, expanding beyond the linkage between producer and distributor to include other enterprises in the product life cycle, beginning with concept design and ending in disposal. Learning methodologies include lecture, case study, and collaborative student group activities in applied research. (3 credits)
  • Biotechnology Innovation: This course is an introduction to biotechnology innovation and strategy.  The framework for innovation and how this translates to regulatory science and drug development will be the focus.  Students will learn key pharma strategy concepts including differences between large and small molecules, clinical and manufacturing statistics, and current pharmaceutical trends. (3 credits)
  • Medical Devices and Diagnostics: An in-depth, graduate course covering core information regarding regulatory, quality and compliance concepts and facts relating to the development, registration, manufacturing, sale, and servicing of medical devices and diagnostic tests. The course emphasizes:  basic concepts of device discovery, design, development and manufacturing, marketing, distribution and servicing processes, applicable laws, quality and compliance oversight, and regulatory issues and registration strategies. (3 credits)
  • Molecular Basis of Manufacturing : This graduate course is aimed at professionals in the fields of pharmaceutical manufacturing, pharmaceutical development, pharmaceutical analysis, clinical supplies and regulatory. The course will also benefit persons interested in intellectual property and patents. The course is fast-paced but assumes no prior knowledge of pharmaceutical manufacturing. (3 credits)
  • Quality Management, Audits & Inspections: Advanced topics in quality management and business improvement methods that apply to the pharmaceutical industry. Emphasis is placed on specific issues of industry audits and inspections, as well as successful selection and presentation of business and quality improvement projects. (3 credits)
  • Project Management in BIRS (3 credits)