RAPS Regulatory Affairs Certification (RAC) Global Scope : RAC-GS

  • Exam Code: RAC-GS
  • Exam Name: Regulatory Affairs Certification (RAC) Global Scope
  • Updated: Sep 26, 2026
  • Q & A: 100 Questions and Answers

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About RAPS Regulatory Affairs Certification (RAC) Global Scope : RAC-GS Exam

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

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Who should take the RAPS RAC-GS Certification Exam?

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RAPS RAC-GS Exam Syllabus Topics:

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

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