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UNIVERSITY OF MISSISSIPPI SCHOOLS AND COLLEGES

The Schools of Nursing and Pharmacy operate on both the Oxford and Jackson campuses. The Schools of Dentistry, Health Related Professionals and Medicine, and the Health Sciences Graduate School, are based in Jackson only. (Additional healthcare programs are available through the School of Applied Sciences on the Oxford campus.) Other than these exceptions, the schools above are on the Oxford campus.

Phar 651: Regulatory Science I

Pharmaceutics & Drug Delivery

This course involves practical and theoretical principles involved in regulatory approvals of pharmaceutical products, and compliance requirements related to the development and manufacturing of pharmaceutical products. Emphasis is placed on Chemistry Manufacturing and Control (CMC) documents contained in regulatory submission packages and major FDA and ICH guidance documents applicable to product development, manufacturing, post-approval changes, and quality assurance. Guest lecturers with expertise in regulatory science will provide the students with the opportunity to discuss problems relevant to the industry. The course will require students to critically review and present publications in small groups and conduct other assignments.

3 Credits

Instruction Type(s)

  • Lecture: Lecture for Phar 651

Subject Areas

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