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Detailed Course Information

 

Fall 2013
Oct 01, 2022
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Information Select the desired Level or Schedule Type to find available classes for the course.

IPPH 52200 - Good Regulatory Practice
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: Graduate, Professional, Undergraduate
Schedule Types: Lecture

Offered By: College of Pharmacy
Department: Industrial and Physical Pharm

Course Attributes:
Upper Division

May be offered at any of the following campuses:     
      West Lafayette Continuing Ed
      West Lafayette


Restrictions:
Must be enrolled in one of the following Colleges:     
      Graduate School
      College of Pharmacy
      Doctor of Pharmacy
May not be enrolled as the following Classifications:     
      Freshman: 15 - 29 hours
      Professional First Year
      Sophomore: 45 - 59 hours
      Junior: 60 - 74 hours
      Junior: 75 - 89 hours
      Freshman: 0 - 14 hours
      Sophomore: 30 - 44 hours

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