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Curriculum

Regulatory affairs is an understanding of current food, drug, medical device, and other product regulations and their application along the development and commercialization spectrum. Regulatory science is the science of developing new tools, standards, and approaches to assess the safety efficacy, quality, and performance of regulated products. There is an increasing need for well-trained regulatory affairs professionals that understand how regulatory science can be used to advance pharmaceutical product development.

The MPS in Regulatory Science degree will train students in two key areas:

The program will impart a foundational understanding of modern pharmaceutical product development, manufacturing, and marketing. It will also train students in global aspects of regulatory affairs throughout a product’s lifecycle as well as effective regulatory writing and strategic considerations to advance product development under different scenarios. Finally, the regulatory science curriculum will also teach students about cutting-edge innovations in toxicology, clinical research, manufacturing, and behavioral science that will enhance safety and efficacy evaluations and monitoring of candidate and licensed products.

The MPS in Regulatory Science is affiliated with the National Professional Science Master’s Association (NPSMA). The purpose of a professional science degree is to provide students advanced scientific training while simultaneously developing highly valued business skills. To learn more about this type of degree, click here.

The purpose of a professional science degree is to provide students advanced scientific training while simultaneously developing highly valued business skills. To this end, the program will also impart a fundamental understanding of written and verbal communication skills, project management, leadership skills, and team building skills required by today’s regulatory professionals. Finally, a seminar series and an experiential learning practicum will help students apply professional skills, make direct connections to potential employers, and ensure graduates are well-trained and ready to meet workforce demands.


Required Courses

The MPS in Regulatory Science requires the completion of 32 credit hours, consisting of 24.5 credit hours in pharmaceutical sciences (PHRS) courses and 7.5 credit hours in professional skills (GRAD) courses.

Classes are taught 100% online and are a hybrid of asynchronous and synchronous learning. Asynchronous courses can be completed at a student’s convenience but include regular touchpoints with instructors. Synchronous courses are scheduled for evening/weekend times to allow maximum flexibility for working professionals. Synchronous courses are also recorded and made available to students who are unable to attend a live session.

Students can enter the program in either the fall or spring semester and can complete coursework on either a full-time or part-time schedule.

Course Descriptions

Pharmaceutical Sciences

*Students must take either PHRS992 or PHRS993

Credit Hours: 0.5

This foundational pharmaceutical science course will provide an overview of the pharmaceutical product development process including challenges and issues associated with each phase. Students will learn how pharmaceutical products are identified for development and key steps in obtaining and maintaining market approval. Students will also learn about business aspects that drive the development strategy. This graduate-level didactic course will be taught asynchronously.

Credit Hours: 2

This foundational pharmaceutical science course will provide an overview of regulatory affairs with a focus on global pharmaceutical product development. Students will learn about medical product regulation in the US and key international markets. Students will also learn about the process for obtaining and maintaining marketing approval along with tools and approaches used by regulatory professionals. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This foundational pharmaceutical science course will cover preclinical aspects of pharmaceutical product development and how they contribute to regulatory approval. Students will learn about the processes of drug discovery, nonclinical in vitro and in vivo approaches to assess pharmacology and toxicology, and key regulatory considerations in the early development of small molecule drugs and biologics. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This foundational pharmaceutical science course will provide an overview of chemistry, manufacturing, and controls in drug development and how they differ by drug product. Students will learn about the processes of assay development, manufacturing, and quality control for small molecules, biologics, and gene and cell therapies. Students will also learn about regulatory submissions and inspections. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This foundational pharmaceutical science course will cover the clinical aspects of pharmaceutical product development and how they contribute to the regulatory approval process. Students will learn about the different phases of clinical development along with considerations for the design, conduct, and evaluation of data from clinical trials. Students will also learn about bioethics and differences in conducting clinical research in the US and EU. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This foundational pharmaceutical science course will cover postmarketing aspects of pharmaceutical product development and how they contribute to maintaining regulatory approval. Students will learn about activities that help to further evaluate and exploit the full potential of a marketed pharmaceutical product including supply chain, sales and marketing, pharmacovigilance, risk management, and postmarketing research. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 1

This foundational pharmaceutical science course will teach basic statistical concepts used frequently during pharmaceutical product development. Students will learn the statistical terminology and approaches that are used to initiate a research investigation, plan a clinical trial, and analyze data. Students will also learn about the role of the statistician in pharmaceutical product development. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This foundational pharmaceutical science course will provide an overview of regulatory science with focus on FDA regulatory science priorities related to innovation in pharmaceutical product development. Students will learn about current research aimed at modernizing toxicology, innovating clinical research and personalized medicine, improving manufacturing and quality, and strengthening social and behavioral science. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Credit Hours: 2

This advanced pharmaceutical science course will prepare students to draft the documents necessary to support and maintain pharmaceutical product marketing approval and advise on regulatory agency interactions. Students will learn about scientific and medical writing styles, methods for reviewing, interpreting, and summarizing pre-clinical and clinical trial data along with crafting effective messages, aligning cross-functional teams, and useful software and tools. This graduate-level applied course will be taught synchronously and involve significant interaction with the course instructor and other students.

Credit Hours: 2

This advanced pharmaceutical science course will train students to integrate strategic business needs, risk assessment, and risk management when developing a regulatory plan. Using case studies and team projects, students will learn to start with the end in mind, analyze critical product life cycle events, and leverage previous experience to successfully achieve regulatory goals. This graduate-level applied course will be taught synchronously and involve significant interaction with the course instructor other students.

Credit Hours: 1

The professional science seminar series provides a forum to educate students about business fundamentals and skills necessary for a successful regulatory career. This course will consist of presentations by invited regulatory professionals who can speak directly about their career paths, challenges, and rewards. Seminars will be held live to allow students to engage with the invited speaker, but meetings will also be recorded for those who cannot attend at the scheduled time.

Credit Hours: 3

This independent research course will serve as a comprehensive examination substitute. Students will conduct a regulatory-related research project to gain familiarity with regulatory guidance and implementation, project management, and professional communication skills. The course will require significant out-of-class effort as well as frequent interactions with the instructor and other students and will culminate in a formal presentation with both peer and instructor evaluation.

Credit Hours: 3

Students with <1 year of professional experience will be encouraged to complete this experiential learning practicum as a thesis substitute. The experiential learning practicum is an individualized, mentored, and experiential learning opportunity designed to bridge a student’s academic training and non-academic practice. Prior to enrolling in the course, students will work with program administrators to identify a sponsoring organization (e.g., CROs and biotech companies), mentor, and internship project. Students will then use the semester to complete a regulatory-related internship project which will culminate in a formal report and presentation with both mentor and faculty evaluation.

Credit Hours: 3

Students will also have the option to complete the more traditional thesis research project, although this will be most appropriate for students with at least 1 year of previous professional experience and will require approval by program administrators. This course will entail a mentored regulatory-science research project to demonstrate independent research skills and expertise in the regulatory science field. Students will use the semester to complete a regulatory science research project which will culminate in a written thesis report and a public oral presentation (including a question-and-answer period) to the academic community which must include the mentor and other committee members.

Professional Skills

Credit Hours: 1.5

Effective leadership begins with understanding your capacity to influence others positively. This online course examines your current leadership style and addresses the relationship of that style to leadership development opportunities including influencing team dynamics, building productive relationships, and managing change as a professional and a leader.

Credit Hours: 1.5

This course focuses on practical project management principles and techniques, demonstrating their effectiveness in the workplace. Key topics include frameworks and methodologies, planning and monitoring projects, risk management, stakeholder management, managing your team, and time and cost management. This course will include group work.

Credit Hours: 1.5

This is a 7-week, online course designed to provide students strategies and tactics for clearly, concisely, and convincingly communicating and positioning their ideas in business settings. Students will explore some of the fundamentals of business writing, including practices for writing memoranda, emails, letters, proposals, executive summaries, and discuss how to be persuasive and engaging through these writings. Students will also explore best practices for presenting and pitching ideas and approaches viewed through both entrepreneurial and intrapreneurial lenses. Several presentations will be offered by invited speakers to provide additional context for these skills and experiences.

Credit Hours: 1.5

The seminar series provides a forum for students to: (1) understand their job values; (2) develop and refine professional presence and job search materials (e.g., LinedIn, resume/CV, cover letter); (3) gain an appreciation of, and comfort with, networking and informational interviewing; and (4) develop an individual development plan and corresponding action plan through one-on-one coaching. The sessions will include workshops led by industry representatives who speak directly about their career challenges and rewards, and individuals with expertise in teaching professional skills.

Credit Hours: 1.5

Team Collaboration is a half-semester course and development series intended to prepare Carolina graduate students to work within multidisciplinary teams and complete real-world projects designed jointly with partnering companies and organizations. This 14-week series will support the ability of Carolina graduate students to develop skills in several areas, gain practical work experience as part of a cross-disciplinary team, and leverage their disciplinary training and creativity to move ideas and projects forward in a real-world context.

The series will also reinforce concepts taught in other professional skills classes through the application of learning in other courses to project work. Several presentations will be offered by invited business leaders to provide additional context for these skills and experiences.


Standard Sequence of Courses

 

 

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