Purdue University College of Pharmacy
IPPH 522 - Good Regulatory Practice
Status: not logged in -
courses main page

College of Pharmacy, Nursing, and Health Sciences IPPH 522 - Good Regulatory Practice
Information current as of 10:54 AM on December 6, 2016.

IPPH 522 - Public Information

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.

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

System © 1999-2016 Purdue University. Content © originating instructor(s). All rights reserved.
Purdue University College of Pharmacy. Powered by YACS.
This page last updated 9:24 AM on January 5, 2007.