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May 20, 2024
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BARB 200 - Global Regulatory and Legal Requirements of Quality
3 Credit(s)
Regulations serve as a foundation for good business decisions that protect and promote patient health. Faculty demonstrate the relationship between regulatory requirements, legal accountability and business responsibility, while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, change control and validation. Topics such as the role of guidance documents and industry standards are reviewed, and case studies utilized to support the program. Understanding the “why” of the regulations foster critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence.
Course Frequency: AN
Grading Method: Student option.
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