For more information contact:
Email:bocchino@gwu.edu
Phone: (202) 994-5129

MSHS: Regulatory Affairs

Mission and Focus

The MSHS in Regulatory Affairs and the Graduate Certificate in Regulatory Affairs provides academic education and professional 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.  The MSHS is designed for professionals working in the field of Regulatory Affairs or Clinical Research. The MSHS curricula will prepare graduates to facilitate and lead change and innovation in regulatory practice.

Graduates of the MSHS in Regulatory Affairs programs will further enhance and 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..