CLTR-904 Approaches for Assessing Safety, Quality, and Benefit
Spring for 2017-2018
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.

Credits: 3
Prerequisites: CLTR501 or equivalent

Sections:

CLTR-904-01 Approaches for Assessing Safety, Quality, and Benefit
Spring for 2017-2018
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.

Credits: 3
Prerequisites: CLTR501 or equivalent
Other academic years
There is information about this course number in other academic years:
More information
Look for this course in the schedule of classes.

The academic department web site for this program may provide other details about this course.