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BMS 547 Development of Pharmaceutics and the Regulatory Environment

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.