The MSHS in Regulatory Affairs and the Graduate Certificate in Regulatory Affairs is designed to provide the regulatory affairs professional academic development in regulatory affairs science, regulatory strategy, drug and device development, systems thinking, and the scientific interpretation of product experience and outcomes for practice and safety guidance and regulation.  Developed through collaboration with regulatory affairs professionals within the Food and Drug Administration and from industry, the MSHS and Graduate Certificate in Regulatory Affairs programs are designed to meet the emerging regulatory affairs needs of the 21st century. The MSHS curricula will prepare graduates to facilitate and lead change and innovation in regulatory practice. The Graduate Certificate provides students with the same level of field course content, and is designed for students who already have a graduate degree, preferably in the life sciences.

Graduates of the MSHS and the Graduate Certificate in Regulatory Affairs programs will further enhance advance global clinical development by:

• Leading and collaborating with other scientists, clinical investigators, and sponsors in clinical development.
• Developing a broad foundation of understanding of the philosophies and roles of the regulatory agencies that oversee drug and device development in medicine.
• Providing strategic direction in matters of regulatory science and affairs.
• Integrating years of industry practice and data into new strategies for guiding clinical development.
• Integrating separate sources of health care regulation and guidance into a systems approach to advising sponsors of clinical development.
• Integrating business needs into a regulatory framework.