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Academic Catalog 2021-2022

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  • Biotechnology Regulatory Science, Graduate Certificate

Biotechnology Regulatory Science, Graduate Certificate

2021-2022 Edition

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        • Biodefense and Biosecurity, Graduate Certificate
        • Biopharmaceutical Analytical Sciences, Graduate Certificate
        • Biotechnology, Graduate Certificate
        • Biotechnology Enterprise, Graduate Certificate
        • Biotechnology Regulatory Science, Graduate Certificate
        • Experimental Biotechnology, Graduate Certificate
        • Manufacturing and Quality Operations in Biotechnology, Graduate Certificate
        • Molecular Biotechnology, Graduate Certificate
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        • Process Science, Graduate Certificate
        • Vaccine Development, Graduate Certificate
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  • Course Descriptions
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  • Program Requirements

This certificate was designed in response to a need in the biotechnology industry for individuals, in particular regulators, to obtain a strong foundation in the science behind good regulatory practice today, specifically in relation to biopharmaceuticals.

Complete all courses and requirements listed below unless otherwise indicated.

Core Requirements

Course List
Code Title Hours
BIOT 5330Drug Safety and Immunogenicity3
BIOT 5500Concepts in Regulatory Science3
BIOT 6320Quality Management Systems and Validation3
or BIOT 5340 Introduction to Biotherapeutic Approvals
CHEM 5620Protein Chemistry3


Program Credit/GPA Requirements

12 total semester hours required
Minimum 3.000 GPA required

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