Regulation of the Pharmaceutical Industry
An overview of how the pharmaceutical industry is regulated globally, focusing on the responsibilities and functions of major regulatory authorities, including the FDA, EMA, and MHLW. The module outlines the processes for new drug approvals in the US and EU, types of FDA inspections, and the roles employees play during routine GMP inspections. It also explains the outcomes of FDA inspections, such as 483 reports and Warning Letters, and highlights the potential consequences of non-compliance.
Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.
Duration: 30 Mins
Grade: Core Library
Description
- Understand Global Regulatory Frameworks: Understand the responsibilities of key regulatory authorities worldwide and how they collaborate to ensure drug safety, efficacy, and quality.
- Gain Insights into New Drug Approval Processes: Gain foundational knowledge of the procedural differences between FDA and EMA approval processes.
- Become Familiar with FDA Inspection Types: Learn about the three main types of FDA inspections—Preapproval, Post-approval, and GMP Systems—and their specific areas of focus in order to support regulatory preparedness.
- Recognize Non-Compliance Consequences: Recognize the potential outcomes of non-compliance, including 483 reports, Warning Letters, market bans, or product recalls, and the importance of following GMP regulations.
- Prepare for Regulatory Engagement: Learn how inspections are conducted, the role of facility personnel, and regulatory expectations to build confidence and readiness during audits.
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.
Keywords
- 483 Report
- Compliance
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Good Manufacturing Practices (GMP)
- GMP Systems
- Ministry of Health, Labor, and Welfare (MHLW)
- Pharmaceutical Regulation
- Warning Letter
Module Features
Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen
