The Regulatory Affairs/Quality Assurance program, leading to a
Master of Science in Pharmacy Administration, has been designed to
provide graduates with the extensive legal perspective,
knowledgebase and qualifications related to drug
development, manufacturing, marketing and distribution in U.S.
and global markets.
The program also offers a Online Learning format, which provides a contemporary option for
the current industry professional seeking advancement, or for the
graduate seeking employment into one of the pharmaceutical
industry’s fastest growing careers.
Upon completion of this program the graduate should be able
an understanding of current methods of drug discovery,
pharmaceutical dosage form and design, development processes, and
the FDA approval process.
understanding changing a drug's status and withdrawing products
from the market.
an understanding of the guidelines provided by the FDA for filing
applications and the overall drug approval process.
an understanding in the relevant forms and documents required for
generic applications, for FDA approval.
an understanding of the laws, regulations and procedures of federal
and state guidelines that affect drugs and medical devices during
their development, production and distribution stages.
the FDA guidelines, published workshops, and applicable scientific
literature used for maintaining product safety, efficacy and
an understanding in the difference between US and EU standards in
conducting clinical trails, and how regulatory inspections are
the need for the international drug harmonization process
and its application in global drug development.
an understanding of ethical principles, and the limitations the
government places on human subject research and the marketing of
For more information please contact:
Department of Pharmacy Administration and Allied Health
Dr. Wenchen Wu, Chair
St. Albert Hall Rm. 164
Phone: (718) 990-6640
Fax: (718) 990-6316
Office of Graduate Admission
Robert Medrano, Director