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 Management, Medical Writing
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6/24/2019 - 8/2/2019
$495
Online
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CLASS TYPE:
Online, Web-based instruction
Olson, Suzan, Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products
Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registerd nurse.
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TEXTBOOKS:
No information available at this time.
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NOTE:
Refund deadline: one week after enrollment or start date of section, whichever is later:
6/24/2019 - 8/2/2019
ucsdextension.blackboard.com
You will have access to your course on the published start date.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or unexhealthcare@ucsd.edu for information about when this course will be offered again.