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Viewing: CRA 6202 : Medicines Development

Last approved: Mon, 12 Jan 2015 09:18:07 GMT

Last edit: Thu, 18 Dec 2014 16:05:12 GMT

Catalog Pages referencing this course
School of Medicine and Health Sciences
Clinical Leadership (CL)
CRA
6202
Medicines Development
Medicines Development
201501
3
Course Type
Lecture
Default Grading Method
Letter Grade

No
No

Corequisites

15

Frequency of Offering

Term(s) Offered

Are there Course Equivalents?
No
 
No
Fee Type


No


Examination of nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.
At the completion of this course students will be able to:
a. Demonstrate their ability to examine the commercial, nonclinical, clinical and regulatory aspects that contribute to the development of a clinical development plan.
b. Evaluate and apply nonclinical safety results in relation to clinical trial planning and risk assessment.
c. Demonstrate how commercial and regulatory strategies contributes to the over-all development of an approvable and marketable new investigational therapeutic.
d. Create a clinical trials plan with study designs that will provide adequate results to assess whether the investigational product should move to the next stage.
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Course Attribute


Key: 1964