Graduate Certificate Programs in Regulatory Affairs

Oct 26, 2019

Graduate certificate programs in regulatory affairs are meant to teach professionals in the public health and healthcare industries about subjects related to the necessary regulations as well as industry standards. Many of these certificate programs are aimed at working professionals, so they are available online, as distance programs or on weekends. This article will present an overview of the courses that are generally included in graduate certificate programs focused on regulatory affairs as well as admissions requirements.

Program Overview

Graduate certificate programs in regulatory affairs can be completed in as little as one year, and students can expect to take around 16 total credits. Course topics can include medical device law, regulatory strategies, food regulations, and more. Find out more details about these types of courses below.

Regulatory Strategies

There are a variety of courses that have been built around this topic. Students may learn about regulations on an international scale or the organizations that help to enforce these regulations. When taking these courses, students will learn how regulatory guidelines tie into the product development process.

Safety of Biologics

Biologic products have become more predominant in the healthcare, medical and public health industries. The courses that deal with biologics tend to cover their development as well as the quality management involved in their production. Other topics that are included in these courses are product life cycle, the aspects of regulatory strategies and the assessment of non-clinical data.

Medical Device Law

When dealing with regulatory affairs, persons will need to learn about the types of devices used in the medical, pharmaceutical and biotechnology industries among others. The courses that delve into this topic may be introductory or more advanced in nature. Some of the topics students can expect to cover are product development, marketing, quality assurance, and regulatory guidelines.

Food Regulations

Anything that people ingest for the purpose of nutrition is considered as food and includes things like supplements. It's important to keep food safe in order to keep the public safe, so there are rules in place for that. When taking these courses, students will learn about the regulations that are associated with different types of food.

Risk Management

Courses focusing on risk management are generally built around medical devices and products that are used in the industry. Students will learn about the history that led to the development of risk management programs. By taking these courses, students will be able to assess risks and conduct activities like recalls.

General Admission Requirements

Admission into a graduate certificate program in regulatory affairs usually requires an undergraduate degree with a minimum GPA of 3.0 from an accredited college or university. While most programs don't need the bachelor's degree to be in a specific area, it's best if the applicant has work experience in the healthcare field. Prospective students may need to submit official transcripts, a current resume, a statement of purpose and letters of recommendation. Persons who are not native English speakers may need to submit passing scores on an English Language proficiency exam.

There are a number of graduate certificate programs available in regulatory affairs. These programs are open to persons with a bachelor's degree and, in some cases, work experience related to the area.

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