Current Good Laboratory Practices (cGLP) are federal regulations set in place to ensure investigational new drugs are safe before testing in humans. They are required when conducting preclinical studies to collect data for FDA review and approval for continued studies in Phase I clinical trials. The course will cover fundamental GLP concepts, and illustrate best practices and vetted classroom activities that will assist educators to easily introduce cGLP principles into their classrooms.al regulations set in place to ensure investigational new drugs are safe before testing in humans. cGLP are required for preclinical studies and data collection, used for FDA approval and leading to product testing in humans during Phase 1 Clinical Trials. The course will review these fundamentals and illustrate best practices and vetted classroom activities that will assist educators to easily introduce cGLP principles into their classrooms.
Teaching Current Good Laboratory Practices (cGLP) as a Workplace Skill
Integrating cGLP into Bioscience Curricula
- Understand the importance of current Good Laboratory Practices (cGLP) 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 cGLP regulations
- Recognize how cGLP protocols apply to laboratory studies conducted during the preclinical phases of drug development, explain their purpose, and how they impact laboratory work
- Appreciate how cGLP guidelines influence departmental roles and work-life culture within the research/study organization
- Communicate career opportunities within the (bio)pharmaceutical industry
- Apply enhanced understanding of cGLP to the classroom with a toxicity study activity
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