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Jan 12, 2015 by Joan Butler (joanb)
CRA 6202 : Medicines Development
Mon, 12 Jan 2015 09:18:07 GMT
Thu, 18 Dec 2014 16:05:12 GMT
Catalog Pages referencing this course
Clinical Research Administration (CRA)
Programs referencing this course
CRA-BSMS: Clinical Research Administration
CRA-GC: Clinical Research Administration
CRA-MSHS: Clinical Research Administration
School of Medicine and Health Sciences
Clinical Leadership (CL)
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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.
Uploaded a Course Syllabus
CRA 6202 Printable Syllabus.pdf
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