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RAPS RAC-GS certification is a prestigious and valuable credential for regulatory affairs professionals seeking to advance their careers and improve their knowledge and expertise in regulatory affairs. RAC-GS exam is designed to be comprehensive and covers a wide range of regulatory topics, including global regulatory frameworks, compliance, and quality systems. Successful completion of the RAC-GS exam demonstrates that an individual has the necessary skills and knowledge to navigate complex regulatory landscapes and provides a competitive advantage in the regulatory affairs job market.

The Regulatory Affairs Certification (RAC) Global Scope exam is designed to test candidates' knowledge and understanding of regulatory affairs on a global scale. RAC-GS exam is offered by the Regulatory Affairs Professionals Society (RAPS), which is a leading professional organization for regulatory affairs professionals worldwide. The RAC-GS certification is highly regarded in the industry and is recognized as a mark of excellence in the field of regulatory affairs.

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Post-Market Compliance & Surveillance20%- Pharmacovigilance & Adverse Events
  • 1. Risk Management Plans
    • 2. Global Reporting Requirements
      - Labeling, Advertising & Changes
      • 1. Global Labeling Rules
        • 2. Post-Approval Changes & Variations
          Product Development & Lifecycle Management25%- Clinical Research & Trials
          • 1. Global Clinical Submissions
            • 2. GCP Compliance
              - Chemistry, Manufacturing & Controls
              • 1. GMP Requirements
                • 2. Quality Systems & Documentation
                  Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
                  • 1. Regulatory Intelligence & Risk Management
                    • 2. Global Market Access Strategy
                      - International Regulatory Frameworks
                      • 1. Regional Regulatory Systems
                        • 2. ICH, WHO, IMDRF, ISO Guidelines
                          Regulatory Submissions & Approval20%- Review Process & Interactions
                          • 1. Deficiencies & Response Management
                            • 2. Regulatory Authority Interactions
                              - Global Dossiers & Submission Formats
                              • 1. National & Regional Application Routes
                                • 2. CTD/eCTD Structure

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