Course Description:
Medical devices are uniquely different from drugs and biologics in their regulation and paths to market. Effective clinical trials design and management for devices requires a solid understanding of these issues. This course provides information about devices, including definitions and types, routes to market, regulatory pathways, successful investigational device exemption (IDE) and PMA submissions to the FDA, differences between devices and drugs and biologics, where device regulations are heading, and how to get devices to market most effectively. Managing and reporting adverse device events (MDRs) are also covered.
Note(s):
Students pursuing the Clinical Trials Certificate who are also interested in the Regulatory Affairs Certificate may take "Regulation of Medical Devices and Diagnostics" to fulfill the "Medical Devices: Regulatory Strategies and Marketing Pathways" requirement in the Clinical Trials Program.
Applies Towards the Following Certificate(s) & Award(s):
Accrediting Associations:
CA BRN/LVN Credit - Provider #CEP13114 15.0 Hours
Sections:
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5939 - 026
Medical Devices: Regulatory Strategies and Marketing Pathways
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Status:
Available
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Section Note(s):Early Enrollment Fee: ($544.50 through Jan. 4).
(2 no meetings TBA).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.
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For Credit
1.5 Units
Tue
6:00PM
to
9:00PM
Jan 18, 2011
to Mar 01, 2011
Number of Sessions:
5
| Tuition: |
$605.00 |
| Early Enrollment |
$544.50
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Method of Instruction:
CLASSROOM
Campus:
SANTA CLARA
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