Lifecycle of the Clinical Product
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General
Prefix
ACR
Course Number
622
Course ID
00017003-2024-08-26
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
An overview of the major roles and activities during the different phases in the life cycle of a medical therapy (e.g., medical device, pharmaceutical, combination product).
Credits
Min
2
Max
2
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Describe the components of a Quality Management System.
Outcome
Define the various phases of a medical therapy life cycle and identify primary deliverables for each phase.
Outcome
Define cross-functional roles within a development team and their major responsibilities.
Outcome
Specify clinical research, regulatory, and quality roles, responsibilities, and deliverables within each phase of a medical therapy life cycle.
Outcome
Describe risk mitigation processes.
Outcome
Define the various sources of performance and safety information developed during the development of a medical therapy and identify how to utilize this information.
Outcome
Describe the current medical therapy development climate, including regulatory reform, comparative effectiveness research, and the reimbursement environment.
Course Outline
Course Outline
Dependencies
Courses
ACR622
is a
prerequisite
for:
Programs
ACR622
is a
completion requirement
for: