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
| Code | Title | Hours |
|---|---|---|
| BIOT 5330 | Drug Safety and Immunogenicity | 3 |
| BIOT 5500 | Concepts in Regulatory Science | 3 |
| BIOT 6320 | Quality Management Systems and Validation | 3 |
| or BIOT 5340 | Introduction to Biotherapeutic Approvals | |
| CHEM 5620 | Protein Chemistry | 3 |
Program Credit/GPA Requirements
12 total semester hours required
Minimum 3.000 GPA required