Regulatory Science, Graduate Certificate

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

BIOT 5330Drug Safety and Immunogenicity3
BIOT 5500Introduction to Regulatory Science3
CHEM 5620Protein Chemistry3


Complete 3 semester hours from the following:3
Bioinformatics Computational Methods 1
Biological Electron Microscopy
Plant Biotechnology
Stem Cells and Regeneration
Inventions in Microbial Biotechnology
Advanced Microbiology
Medical Microbiology
Biological Imaging
Ethics in Biological Research
Dynamics of Microbial Ecology
Fundamentals of Biochemistry for Biotechnology
Organic Chemistry for Biotechnology
Introduction to Biotechnology
Team Skills in Biotechnology
Basic Biotechnology Lab Skills
The Biotechnology Enterprise
The Role of Patents in the Biotechnology Industry, Past and Future
Managing and Leading a Biotechnology Company
Biotechnology Entrepreneurship
Economics and Marketing for Biotechnology Managers
Introduction to Biotherapeutic Approvals
Drug Stability
Scientific Information Management for Biotechnology Managers
Introduction to Regulatory Science
Bioprocess Fundamentals
Cell Culture Processes for Biopharmaceutical Production
Downstream Processes for Biopharmaceutical Production
Drug Product Processes for Biopharmaceuticals
Molecular Interactions of Proteins in Biopharmaceutical Formulations
Cutting-Edge Applications in Molecular Biotechnology
Cellular Therapies
Introduction to Biopharmaceutical Technologies
Higher-Order Structure Analytics
Directed Study
Experimental Design and Biostatistics
Pre-co-op Experience
Professional Development for Co-op
Co-op Work Experience
Biotechnology Applications Laboratory
Introduction to Glycobiology and Glycoprotein Analysis
Protein Mass Spectrometry
Protein Mass Spectrometry Laboratory
Principles of Chemical Biology for Chemists
Chemistry and Design of Protein Pharmaceuticals
Molecular Modeling
Advances in Nanomaterials
Chemical Engineering Kinetics
Enterprise Growth and Innovation
Managing Operations in Early Stage Ventures
Entrepreneurship: Services and Retail Business Creation
Business Planning for New Ventures
The American Healthcare System
Organizational Behavior, Work Flow Design, and Change Management
Law for Managers and Entrepreneurs
Information Analysis
Introduction to Nanomedicine
Nano/Biomedical Commercialization: Concept to Market
Biomedical Chemical Analysis
Behavioral Pharmacology and Drug Discovery
Biophysical Methods in Drug Discovery
Pharmaceutical Sciences Laboratory
Entrepreneurial Marketing and Selling
Lean Design and Development

Program Credit/GPA Requirements

12 total semester hours required
Minimum 3.000 GPA required