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Introduction to the US FDA Regulations

This course covers the US FDA regulations pertaining to research in Title 21 of the Code of Federal Regulations. The parts covered include 312, 812, 50, 54, 56, and 11. This course also includes a comparison between parts 312 and 812 for drug and device studies regulations.

Learners will understand regulation of investigational new drugs and investigational devices by the FDA, and explain the responsibilities of Sponsors and Investigators in Investigational New Drug and Investigational Device Exemption studies. 

Learners will understand the role of informed consent in ensuring human subject protection, the required elements of and documentation process for informed consent, the requirements for IRB composition, operation and compliance, the goals of disclosing financial interest, and required controls for electronic records and signatures.

Learners will review the key requirements of 21 CFR Parts 312 and 812, identify the primary similarities and differences, and understand the development pathways of new drugs and new devices.

The approximate time to complete each session and quiz is noted next to each topic.

Upon successful completion of this course, learners will receive 2.00 continuing education contact hours.

Sessions Included:
    1.     Introduction to the US FDA Regulations Part I: 21 CFR Parts 312 and 812 - (55 minutes)
    2.     Introduction to the US FDA Regulations Part II: 21 CFR Parts 50, 54, 56, and 11 - (40 minutes)
    3.     Comparing 21 CFR Part 312 and 21 CFR Part 812 - (55 minutes)

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