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    Regulation of the Pharmaceutical Industry

    Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.

      Duration: 30 Mins

    SKU: PGB-1102-SPL02-EN Categories: , , , , Tag:


    Learning Objectives:

    • Explain why the pharmaceutical industry is regulated.
    • List the main regulatory bodies within the global pharmaceutical industry.
    • Define the responsibilities of regulatory authorities.
    • Explain how the new drug approval process works in both the US and the EU.
    • List the three main types of FDA inspection.
    • Describe the purpose of each type of FDA inspection.
    • Explain the difference between a 483 report and a Warning Letter.
    • List three potential consequences of failing to correct violations detailed in an FDA Warning Letter.
    Module Features:

       Voice Over
        Knowledge Checks
       SCORM/AICC compatible
        Full Screen

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