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Master of Science in Clinical Research and Regulatory Administration
CLIN RES 402-0
( Core Course ) Drug and Device Development
Introduces the rationale for, practical aspects of, and new issues in drug and device development as well as the relevant industry and government policies and regulations. Class topics include: illness targets, unmet medical needs, and the pharmaceutical life cycle; scientific basis of drug development (e.g., drug discovery, pre-clinical drug development, patient studies including clinical pharmacology); protocol and budget preparation; pharmacoeconomics and quality of life; regulatory aspects (FDA, GCP, ICH, QA); pharmacogenetics and information technology; biotechnology and technology transfer; role of academia in drug development. This course was previously advertised as MSCI 303. This class may be taken as an elective for MQARS.
