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Georgetown University


Detailed Course Information


Fall 2017
Jan 17, 2018
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Information Select the desired Level or Schedule Type to find available classes for the course.

CLTR 904 - Approaches to Assessing Safety
This course will examine the development and application of new or existing methods along the development pipeline to assess quality and safety of medical products for use in humans. The course will explore the various methods to ensure safety and quality for research participants, patients in treatment, and the public health. Modern tools and methods can analyze clinical data and inform regulators about the safety of medical products and ensure the quality of emerging technologies (i.e., nanotechnologies). Students will learn terminology, approaches, and current practices by which regulators assess quality and safety as well as how novel approaches are incorporated into the regulatory review process to account for latest advances in science. Concepts are introduced and explored in a step-wise fashion through the use of case studies. A series of short essay exams will be administered throughout the semester to gauge student learning and comprehension of the basic assessment approaches before continuing to more advanced concepts. 

3.000 Credit hours
3.000 Lecture hours

Levels: MN or MC Graduate
Schedule Types: Lecture

Clinical/Tranlation Research Department

Must be enrolled in one of the following Levels:     
      MN or MC Graduate

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