Aug 14, 2022  
2014-2015 University Catalog 
    
2014-2015 University Catalog [ARCHIVED CATALOG]

TLI 52200 - Good Regulatory Practice


Credit Hours: 3.00. Includes 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 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 Summer Fall Spring.