Graduate Certificate Biopharmaceutical Domestic
Regulatory Affairs Online

The online Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs program is designed to provide students with a greater understanding of how new drugs, treatments, and medical devices are evaluated and regulated by the FDA. The online format offers greater flexibility for professionals already at work in related fields such as science, medicine, or law, as well as enabling new levels of interaction with faculty and fellow students.

This graduate program gives students the knowledge and skills needed to effectively manage a range of tasks related to regulation, such as assuring compliance, reducing costs, and improving techniques governing acquisition and measurement. Courses in this program address medical device regulation and the industry's unique software development and validation issues. Upon graduation, students will possess a vocabulary of over 750 acronyms and technical/regulatory words to which FDA has applied its own distinctive meaning.

This certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, offered by Northeastern University’s College of Professional Studies.

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