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Master's in Regulatory Science Programs

Feb 23, 2018

The most common coursework in a regulatory science master's degree program involves the study of research ethics, modern issues in gene therapy, how medical devices are regulated, and the management of risk.

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When you enroll in a master's degree program in regulatory science, you will encounter a variety of courses discussing how drug development occurs. This program will help you better understand how drugs are developed for markets.

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Regulatory Science Master's Degree Program Coursework

A master's degree program in regulatory science will take between 30 and 40 hours of coursework to complete. These programs are for individuals interested in research careers related to ensuring the safety of products regulated by the FDA as well as the efficacy of the regulatory process. The following are a few examples of the courses you will find.

Medical Device Regulation

Medical devices are closely regulated by the U.S. Food and Drug Administration. Students attending this course come to a comprehensive understanding of how those regulations are put in place. This course acquaints students with the legal framework governing medical devices, the methods by which the FDA regulates those devices, and the specific administrative and legal requirements placed upon the development of medical devices.

Gene Therapy

A new field in medical science is the area of gene therapy. In this course, students become better acquainted with topics such as gene transfer, genetic disease, and gene therapy's potential use in treating a variety of diseases, including cancer and AIDS. This course illustrates how the medical industry is currently developing techniques for responding to various disorders. Students also come to know more about the current issues and debates surrounding patenting.

Research Ethics

Scientists and researchers must commonly contend with the ethical obligations that are placed upon them during experimentation and product development. Students in this course learn about the ethical concerns involved with both animal and human subject trials. Part of this coursework includes coming to a better understanding of issues such as informed consent. Students also learn about the ethics of research and publication, including authorship and attribution.

Risk Management

There is a degree of risk involved in research and development, and risk analysis is the process by which risk assessment, management, and communication are united to mitigate against negative outcomes. Coursework instructs students in all aspects of managing risk, including communicating concerns and weighing alternatives after the results of a risk analysis have been performed.

Drug Development

An important part of the medical field is the development of drugs for treating various disorders. This course gives students an opportunity to learn more about how drug performance is evaluated and the tools used during the evaluation process. Students also come to know more about the decision-making process in moving development forward to market.

Regulatory Science Master's Degree Admission Requirements

Some schools accept applicants with a bachelor's or master's degree in a related discipline. However, there are some schools requiring prospective students to hold a Ph.D., a professional doctorate (such as an MD or VDM) or a master's degree in nursing. Additional requirements can include GRE scores, letters of reference, and a statement of purpose documenting such things as why you want to pursue a degree in this field.

Coursework in a regulatory science master's degree program includes coursework in ethics, risk management, and the development of drugs. This curriculum can provide you with a better understanding of how medical products are regulated.

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