The Graduate Certificate in Biopharmaceutical International Regulatory Affairs focuses on compliance standards that facilitate the global commercialization of safe and effective biotechnology and pharmaceutical medicinal products.

Through a targeted curriculum, you will be trained to assess international regulations and interpret their likely impact on a company’s global commercialization strategies. The curriculum covers regulatory environments in Europe, Latin America, Australia, Japan, and other emerging economies.

Coursework also covers product approval processes, regulatory analysis, and liability laws. The program will provide core regulatory knowledge to students entering the field from bench research, clinical studies, quality control/assurance, pharmacy, bioengineering, business, and legal analysis.

Through collaboration and experiential learning opportunities students will gain a real world understanding of international regulatory requirements necessary to implement such strategies.

Upon completion of this certificate program, students are well positioned to understand the international regulatory requirements for countries where new biopharmaceutical products will be marketed.

Program objectives

• Be able to assess international regulations and to provide an interpretation of their likely impact on the biopharmaceutical product manufacturers, healthcare practitioners, and patients
• Gain an understanding of international regulatory requirements for countries where new biopharmaceutical products will be marketed
• Understand evolving compliance and international regulations

Unique Features

1. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs
2. Specialized focus on the international marketplace
3. Offered online or at the Boston campus for maximum flexibility