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RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS real prep

RAC-GS
  • Exam Code: RAC-GS
  • Exam Name: Regulatory Affairs Certification (RAC) Global Scope
  • Updated: Sep 11, 2026
  • Q & A: 100 Questions and Answers
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  • Exam Format: MCQs
  • Passing score: 65%
  • Languages: English
  • Time Duration: 120 Minutes
  • No. of questions: 100

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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. Regulatory Authority Interactions
        • 2. Deficiencies & Response Management
          Topic 2: 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 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%- Labeling, Advertising & Changes
                          • 1. Post-Approval Changes & Variations
                            • 2. Global Labeling Rules
                              - Pharmacovigilance & Adverse Events
                              • 1. Risk Management Plans
                                • 2. Global Reporting Requirements

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