May 25, 2024  
2021-2022 University Catalog 
2021-2022 University Catalog [ARCHIVED CATALOG]

ABE 51200 - Good Regulatory Practices

Credit Hours: 3.00.  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. Typically offered Fall Spring Summer.Credits: 3.00