3 Credits

Spring 2023
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Spring 2023 Instructors: Kari Clase, Stephen Byrn

Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, good clinical practices. The meaning of these regulations, the globalization of practices and the roles and responsibilities of various professionals implementing these regulations will be addressed. Special emphasis will be 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 ABE 51200 from Purdue University - West Lafayette.

Fall 2024 Schedule:

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