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| IPPH 52200 - Good Regulatory Practice |
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Credit Hours: 3.00. 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. Typically offered Summer Fall Spring.
3.000 Credit hours Levels: Undergraduate, Graduate, Professional Schedule Types: Lecture Offered By: College of Pharmacy Department: Industrial and Molecular Pharm Course Attributes: Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette |
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