Purdue University College of Pharmacy
IPPH 522 - Good Regulatory Practice
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College of Pharmacy, Nursing, and Health Sciences IPPH 522 - Good Regulatory Practice
Information current as of 6:30 PM on April 30, 2016.

IPPH 522 - Public Information

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Course Information

Credit Hours: 3
Prerequisites: IPPH 521, PHAD 501
Semesters: Summer, Fall, Spring
Catalog description:

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.

Course Staff

Instructors: Stephen Robert Byrn, Kari L. Clase
Supporting Staff: Mary Ellen Hurt


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