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RAPS RAC-GS

RAC-GS

Exam Code: RAC-GS

Exam Name: Regulatory Affairs Certification (RAC) Global Scope

Updated: Aug 04, 2026

Q&A Number: 100 Q&As

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About RAPS RAC-GS Exam Questions and Answers

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

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

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Topics covered by the RAPS RAC-GS Certification Exam:

RAC-GS exam dumps will cover the following topics of the RAC-GS Certification Exam:

  • Health Science: 10%
  • Public Health: 10%
  • Pharmaceuticals: 25%
  • Medical Devices: 35%
  • Bio-Technology: 20%

RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
  • 1. Quality Systems & Documentation
    • 2. GMP Requirements
      - Clinical Research & Trials
      • 1. Global Clinical Submissions
        • 2. GCP Compliance
          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
                  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
                          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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