LAW577A
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LAW577A - Development and Innovation: Biologics, Devices, and Diagnostics
Course ID
040438
Course Description
What are the fundamental incentives for development in the biomedical space? The topics covered in this course include introducing key concepts in oversight by the Food and Drug Administration, biologics and biosimilars, regulation of diagnostics, along with the medical device development and approval process. Proving safety and efficacy in clinical development and promoting innovation through the adoption of new technologies and novel adaptive trial designs will also be discussed. The course concludes with a survey of Intellectual Property rights regime for medical products and the regulatory challenges in international markets.
Min Units
3
Max Units
3
Repeatable for Credit
No
Grading Basis
GRD - Regular Plus/Minus Grades A, B, C, D, E
Career
Law
Course Requisites
May be convened with
Component
Lecture
Optional Component
No