PhD in Regulatory Science Programs

Feb 25, 2018

A PhD program in regulatory science is hard to find but will include coursework in risk management, clinical trial design, submission to the FDA, and the laws regulating medical products. Keep reading to learn more about program requirements.

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There aren't many doctoral programs in regulatory science. In the rare instance when you do find one, much of the early core coursework will overlap with the graduate courses offered in a master's program, which are more common.

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Ph.D. in Regulatory Science Program Coursework

Students in a regulatory science PhD program often need to complete 64 credits to attain their degree. Some programs are available online. Here are a few of the courses you can expect to find:

Medical Product Regulation

Students attending a program in regulatory science will typically need to complete a course in medical device regulation. This course discusses how the U.S. Food and Drug Administration regulates medical devices. As part of their coursework, students become familiar with the laws and regulations pertaining to medical devices, how the FDA oversees regulation, and the legal requirements placed on medical device approval.

Research Ethics

A common part of work in the science field is adherence to ethical requirements. Coursework in this area gives students a better understanding of the ethical issues that are brought up as a part of scientific research. Other topics include the ethics pertaining specifically to research with animal and human subjects as well as when it is appropriate to include such subjects. Students are also taught about the ethical requirements of publishing articles and appropriate attribution of sources.

Risk Management

Risk management can be considered alongside risk communication under the larger umbrella of risk assessment. Coursework in this area guides students to a better understanding of when to consider alternatives following the results of a risk and the development of regulatory measures. During this course, students become more familiar with the methodologies used to manage risk and the theories that underpin risk management.

Clinical Trial Design

The design of clinical trials is important when assessing the safety of products prior to public release. Promising medical compounds can be rejected if the study design isn't sufficiently rigorous. This course teaches students about how to design a study, select a population, apply statistical methods, gather participants, and adhere to various regulations while meeting ethical obligations. Students may go in-depth with various analytical techniques and correlative statistical approaches.

Regulatory Submissions

Submitting anything to the FDA for approval requires appropriate communication and knowledge of the submissions process. This course gives students an opportunity to come to a better understanding of getting drugs moved to market via distribution across state lines. Students also get a chance to sharpen their written communication skills as a part of their coursework.

Admission Requirements

A PhD program in regulatory science typically has standard admissions and application requirements, including a resume or curriculum vitae demonstrating previous work history, a bachelor's degree, and letters of recommendation. Schools could require an undergrad degree in a field such as engineering or life sciences, transcripts and GRE scores. Candidates might also need to have taken courses in biochemistry and cellular biology.

Doctoral work in regulatory science requires students to become better acquainted with the ethics of research, designing clinical trials, and making submissions to the FDA. At the program's conclusion, graduates can be prepared for a career researching bioscience products.

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