Master's Degree in Regulatory Affairs Programs

Nov 30, 2017

Students who are interested in pursuing a master's degree in regulatory affairs can do so in an on-campus format. We will discuss the course requirements for these programs, as well as admission requirements.

Master's degree programs in regulatory affairs are most commonly found in online formats, though it is possible to enroll in a more traditional on-campus program. These programs are designed for individuals who are interested in pursuing a career that involves the regulation of food, drugs, and medical devices. Below, we will discuss these programs in greater detail and highlight some of the common courses that students often take in these programs as well as general admission requirements.

Master's Degree Programs in Regulatory Affairs

Master's degree programs in regulatory affairs are typically offered as Master of Science degrees and can generally be completed in two years. These programs often require students to take a number of courses as part of a core curriculum and then typically allow students to select electives or a specialized track of study in an area that interests them. Common courses include:

FDA Fundamentals and Law

Programs in regulatory affairs typically include a course that provides students with an introduction to the FDA and FDA laws. Students will learn how various regulations are developed over time, discuss the differences in laws regarding prescription and over-the-counter drugs, and look at how new products and devices are created. Other topics that may be discussed in a course like this include laws regarding imports and exports, international regulations, the Freedom of Information Act, and FDA enforcement.

Medical, Scientific, and Research Writing

These programs also often include a course that focuses on teaching students the proper way of writing in the field of regulatory sciences. Students may read various technical and medical journal articles in order to develop a deeper understanding of the way writing is done in this field and will then focus on improving their own writing skills. The course may specifically focus on teaching students how to prepare certain documents like lab result reports and informed consent forms.

Quality Control, Assurance, and Management

Students enrolled in these programs will likely take at least one course that covers topics in quality control, which is the process that pharmaceutical and drug companies must undergo in order to ensure that they are producing safe and reliable products. Students may study the differences between quality control and quality assurance, as well as the regulatory procedures regarding the production of medical devices. The course will also discuss how companies set standards for their products and drugs and how they ensure that these standards are being met.

Clinical Trials and Research

In this course, students will learn about the process by which new drugs are tested through clinical trials that involve human participants. Students will study how to create a legal, safe, and effective clinical trial by learning about the laws and regulatory processes that dictate how clinical trials should be conducted. This course will likely cover topics like participant recruitment, IRB and FDA cooperation, and participant safety.

Drug Development

This course will focus on the process by which new prescription drugs are developed and approved for use by doctors and patients. Students will learn about pharmaceutical research, the various phases involved when developing a new drug, and the role that regulatory agencies play in this process. This course may cover topics like generic drugs, the marketing of drugs, and clinical trials.

General Admission Requirements for Master's Degree Programs in Regulatory Affairs

Students who are considering enrolling in a Master of Science in Regulatory Affairs program will typically need to possess a bachelor's degree in a health sciences-related field. Some programs may require that students also have some work experience before being eligible for the master's degree program. When submitting an application, students will need to submit a completed application form, application fee, letters of recommendation, transcripts, resume, and personal statement.

Master of Science programs in regulatory affairs will prepare students for a number of careers in the food and drug regulation field by requiring students to take coursework that exposes them to a number of fundamental, as well as advanced, concepts in this field.


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