Prerequisite: Open to students with a declared concentration in Regulatory Compliance, or permission
of the instructor. (Summer/3 credits)
The development of pharmaceutical products is under strict regulatory control. This course
examines the interaction of the scientific and regulatory environment required to assure the
safety and efficacy of pharmaceutical products for human and veterinary use. The process for
development of pharmaceutical products is discussed relative to issues of ethics, environmental
protection, validation, audits and business decisions which accompany the development of
ethical drugs. The regulatory approval processes for new drugs in developed countries are
contrasted to those of developing nations. Course grades are determined by evaluation of mterm and final exam.