Online master's degree programs in regulatory affairs are usually offered as a Master of Science degree program. Students in these programs may still participate in research and/or internship opportunities while completing their online coursework. Explore these degree programs and some of their requirements.
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Information for Online Master's Degree Programs in Regulatory Affairs
Students in online master's degree programs in regulatory affairs can usually complete the program in 1 to 2 years, can take it full- or part-time and may be able to choose from various concentrations, such as international regulatory affairs, general regulatory affairs, operational regulatory affairs, clinical research regulatory affairs and more. Although coursework may vary based on these concentrations and/or students' interests, here we discuss a few of the common course topics for these programs.
Regulatory Strategy in Devices
Students in regulatory affairs degree programs usually take a course that explores different aspects of regulating the development of medical devices. Some of these courses may focus on the strategies to analyze and evaluate the regulation of these devices, while other courses may examine the approval requirements of these devices and legislative reforms in the field. Students in these courses further develop their critical thinking skills as they explore the interaction between regulation and development.
Regulatory Strategy in Drugs
Courses in regulatory strategy in drugs and biologic products are similar to the devices courses, but they focus on the regulation of drug and biologic development and production. Some of these courses may look specifically at development in the United States and how the Food and Drug Administration (FDA) is involved, while others may take a broader approach and examine global regulatory strategy. Students in these courses examine the regulatory strategy during the development, clinical testing, production and marketing stages of these products.
Global Regulatory Affairs
As the name suggests, courses in global regulatory affairs explore the various components of regulation at the global scale. Students examine the global regulatory requirements for a wide range of products through the entire product life-cycle, from development to promotion. These courses typically involve class discussions about case studies with real-world situations and practical exercises.
Students in these programs may take general courses in clinical research for regulatory affairs or specific courses examining the regulation involved in the design and/or management of clinical trials. Students in these courses learn about the terminology used in clinical trials, issues involved in clinical trials and how to achieve regulatory strategies in the trials. These courses also discuss the safety aspects of clinical trials and working in a laboratory setting, as well as the regulatory strategies for data management.
Similar to some other courses in the program, courses in regulatory compliance may be broken up into specific courses that examine topics like regulatory writing or regulatory documentation, while others take a broader overview of regulatory compliance. Broader courses may examine the compliance measures in creating, labeling and marketing a product, as well as the necessary reporting and current compliance issues. Courses in regulatory documentation or regulatory writing go into greater detail about the specific practices and requirements in the field at the national and/or international levels.
Common Entrance Requirements
Applicants to online master's degree programs in regulatory affairs need to include their official transcripts, letters of recommendation, a statement of purpose and a resume or CV with their application. Students must have a bachelor's degree, and some programs may have a minimum GPA requirement. Some degree programs may prefer relevant work experience, while others may have minimum work experience requirements for particular concentrations. International students typically need to include their TOEFL or IELTS test scores to demonstrate English proficiency.
Students interested in regulatory affairs can pursue a Master of Science in the subject completely online. These programs may offer different concentrations and usually provide students with research opportunities.