2021-2022 Academic Catalog 
    
    Apr 19, 2024  
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2021-2022 Academic Catalog [ARCHIVED CATALOG]

BIOT 2100 - Good Clinical Practice: Exploring the Basics

The course will provide an overview of the stages and fundamentals of Good Clinical Practice (GCP), which is recognized globally as a standard and ethical way of testing human subjects.  During the course, students will learn relevant US FDA regulations for GCP which meets the guideline from the Society of Quality Assurance (SQA).  Other guidelines from agencies such as ICH or ISO will be discussed.  Students will be presented a comprehensive view of the GCP practices in human clinical trials and the auditing process of parties and sites involved in the clinical study.

Prerequisites: BIOT 1000 - Introduction to Biotechnology  

BIOT 1200 - Business Operations Management for Biotechnology  

COMM 2100 - Scientific and Technical Communications for Biotech Industry  

Anticipated Terms Offered: spring
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