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: Students identify a problem within their organization, define the current state supported by evidence, develop a proposal based upon literature review and evidence within their organization, and develop a plan with rationale and recommendations for an improved future target state. The course places a strong emphasis on leadership, professional communication, and the interpretation of research findings within the biotechnology industry to build a foundation for integrating theoretical research approaches with a unique project that has practical application in the field of biotechnology. Quantitative and qualitative research methodology will be introduced, including the application of fundamental statistical methods in design and interpretation of research findings in professional academic, industrial, and regulatory organizations. (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)
• Global Leadership in BIRS:  This course provides a foundation to the theoretical foundation and empirical research associated with emerging strategies and theories in the study of global leadership. The course also addresses the practical application of leadership to the biotechnology industry including activities to help encourage collaboration and innovation. Students will build self-awareness and learn about the evolution of leadership as a process that requires vision, passion and discipline. Guest lecturers from both industry and regulatory organizations will provide applications of the topics above within the biotechnology manufacturing and regulatory industry. (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 in Regulatory Science: 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 in BIRS: This advanced course will integrate diverse aspect of Medical Devices including diagnostics and drug-device combinations relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for preclinical research, clinical trials and new drug and device approvals. Special topic lectures will be given. Considerable time will be devoted to case studies and independent work. (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: The factors influencing decisions during the initiation, implementation, and termination of industrial and manufacturing projects are examined. Students work as project teams, using project management tools to develop implementation strategies. (3 credits)