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Last Updated: Jul 22, 2026

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Passing Score, Duration, No of question, languages, Format of the RAPS RAC-GS Certification Exam

RAC-GS exam dumps elaborated the detailed info about the exam. The overview of the info about Passing Score, Duration & Question for the RAPS RAC-GS Certification is given below:

  • Languages: English
  • Passing score: 65%
  • No. of questions: 100
  • Time Duration: 120 Minutes
  • Exam Format: MCQs

RAPS RAC-GS Certification Exam is a computer-based exam that consists of 120 multiple-choice questions. Candidates are given four hours to complete the exam, which is administered at Pearson VUE test centers worldwide. The questions are designed to test the candidate's knowledge of global regulatory affairs and are based on the RAPS RAC-GS Exam Content Outline, which is updated regularly to ensure that the exam is relevant and up-to-date.

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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.

RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Regulatory Submissions & Approval20%- Global Dossiers & Submission Formats
  • 1. National & Regional Application Routes
    • 2. CTD/eCTD Structure
      - Review Process & Interactions
      • 1. Deficiencies & Response Management
        • 2. Regulatory Authority Interactions
          Topic 2: Post-Market Compliance & Surveillance20%- Pharmacovigilance & Adverse Events
          • 1. Global Reporting Requirements
            • 2. Risk Management Plans
              - Labeling, Advertising & Changes
              • 1. Global Labeling Rules
                • 2. Post-Approval Changes & Variations
                  Topic 3: Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
                  • 1. GMP Requirements
                    • 2. Quality Systems & Documentation
                      - Clinical Research & Trials
                      • 1. GCP Compliance
                        • 2. Global Clinical Submissions
                          Topic 4: Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
                          • 1. Regulatory Intelligence & Risk Management
                            • 2. Global Market Access Strategy
                              - International Regulatory Frameworks
                              • 1. ICH, WHO, IMDRF, ISO Guidelines
                                • 2. Regional Regulatory Systems

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