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

  • Exam Code: RAC-GS
  • Exam Name: Regulatory Affairs Certification (RAC) Global Scope
  • Updated: Aug 02, 2026
  • Q & A: 100 Questions and Answers

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Introduction to the RAPS RAC-GS Certification Exam?

Regulatory Affairs Certification (RAC) Global Scope is simply called RAC-GS Certification Exam. This Certification Exam is designed by the RAPS to test the candidate's knowledge, skills, and abilities in Regulatory Affairs (R&D), Health Science (Pharmaceutical), Biotechnology, medicinal Device, and Public Health, to meet the requirements of Regulatory Affairs Professionals and other stakeholders. RAC-GS exam dumps can help you get your certification easily. The RAC-GS Certification Exam is also intended for use by educational and training institutions offering R&D programs and academic degrees related to regulatory affairs, health science, biotechnology, medical device, and public health. Investors, people in financial services, business analysts, and consultants are also eligible to take this exam. Labeling is granted to individuals who pass the exam. The candidates must then pass the RAC-GS Certification Exam as well as the RAPS RAC-GS Certification Exam.

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
  • 1. Quality Systems & Documentation
    • 2. GMP Requirements
      - Clinical Research & Trials
      • 1. GCP Compliance
        • 2. Global Clinical Submissions
          Topic 2: Post-Market Compliance & Surveillance20%- Pharmacovigilance & Adverse Events
          • 1. Global Reporting Requirements
            • 2. Risk Management Plans
              - Labeling, Advertising & Changes
              • 1. Post-Approval Changes & Variations
                • 2. Global Labeling Rules
                  Topic 3: 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 4: Global Regulatory Environment & Strategy35%- International Regulatory Frameworks
                          • 1. ICH, WHO, IMDRF, ISO Guidelines
                            • 2. Regional Regulatory Systems
                              - Regulatory Strategy & Planning
                              • 1. Regulatory Intelligence & Risk Management
                                • 2. Global Market Access Strategy

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