Northeastern University

Program Information

Degree Offered

Graduate Certificate in Biopharmaceutical International Regulatory Affairs

Format: Campus, Online

Program Description:

The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies becomes imperative in the global marketplace.

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the company. As a result of the program, students will gain an understanding of international regulatory requirements for countries where new products will be marketed.

Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies joining the global market, attorneys, paralegals, and biotechnology, pharmaceutical, and medical device researchers will benefit from understanding compliance and international regulations, as well as how to streamline the regulatory process. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Tuition & Financial Aid

Financial Aid Offered: Yes

Classification: Doctoral/Research Universities - Extensive

Institution Sector: Private not-for-profit

Locale: Large City

Size & Settings: 20,000 and above