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This keystone course examines the drug development process and history of clinical trials. Topics include sources of new drugs & devices; the process of discovery; how a discovery becomes a drug or device; the definition, phases, and purposes of both pharmacological and clinical development; the history of drug/device regulation and effects of historical events on regulatory oversight; investigative new drug applications; and premarket approval applications.

Other Credits: BRN: 24 CE hours.

Note: Requirement for Professional Certificate in Clinical Trials Design and Management. Prerequisite for Science of Clinical Trials Design, and Human Subjects Protection and IRBs.

Course Number: FPM-40173
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and ManagementMedical Writing

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