Good Laboratory Practices (GLP) are federal regulations set in place to ensure investigational new drugs are safe before testing in humans. They are required for preclinical studies and data collection, used for FDA approval leading to product testing in humans during Phase 1 Clinical Trials. The course will cover fundamental GLP concepts, and illustrate best practices and vetted classroom activities that will assist educators to easily introduce GLP principles into their classrooms.

Learning Objectives

• Understand the importance of Good Laboratory Practices (GLP) when conducting studies to support FDA approval of an investigational new drug for human clinical trials
• Review the historical events that led to the establishment of GLP regulations
• Recognize how GLP protocols apply to laboratory studies conducted during the preclinical phases of drug development, explain their purpose, and how they impact laboratory work
• Appreciate how GLP guidelines influence departmental roles and work-life culture within the research/study organization
• Communicate career opportunities within the pharmaceutical & biopharmaceutical industry
• Apply enhanced understanding of GLP to the classroom with a toxicity study activity