|College of Pharmacy|
|IPPH 522 - Good Regulatory Practice|
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|IPPH 522 - Good Regulatory Practice
Information current as of 6:30 PM on April 30, 2016.
The materials for this course are only accessible to current students and instructors. In order to access course materials you will be required to provide a valid username and password.
Credit Hours: 3
Prerequisites: IPPH 521, PHAD 501
Semesters: Summer, Fall, Spring
A review of the FDA and ICH regulations on good manufacturing, good laboratory, and good clinical practices. The meaning of these regulations, the globalization of practices, and the roles and responsibilities of various professionals implementing these regulations are addressed. Special emphasis is on detailed coverage of the process for the assembly and submission of an IND or NDA and the function of the regulatory affairs department in a pharmaceutical company.
Instructors: Stephen Robert Byrn, Kari L. Clase
Supporting Staff: Mary Ellen Hurt