Why Biopharmaceutical International Regulatory Affairs?
The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce.
The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on compliance standards that facilitate the global commercialization of safe and effective biotechnology and pharmaceutical medicinal products.
The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies is imperative in the global marketplace. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the biopharmaceutical product manufacturers, healthcare practitioners, and patients.
As a result of their completion of the program, students will gain an understanding of international regulatory requirements for countries where new biopharmaceutical products will be marketed. Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies into diverse global markets, current global regulatory affairs professionals, attorneys, paralegals, and biopharmaceutical science researchers will benefit from understanding evolving compliance and international regulations, as well as how to streamline global regulatory processes.
- Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
- Specialized focus on the international marketplace
- Boston is a hub for the healthcare, biotechnology, and life science sectors
What you'll study
Complete a minimum of 10 quarter hours:
This program requires successful completion of a minimum of 17 credit hours that meet the degree requirements.