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The Regulatory Affairs Certification (RAC) Global Scope Exam, also known as the RAPS RAC-GS Exam, is a globally recognized certification program for regulatory professionals. RAC-GS exam is designed to test the knowledge and skills required for regulatory affairs professionals to navigate the complex regulatory landscape of various regions and countries around the world.
The RAC-GS (Global Scope) exam is a specialized version of the RAC exam that is designed for regulatory professionals who work in a global regulatory environment. The RAC-GS exam covers a wide range of topics that are relevant to regulatory professionals who work in different regions of the world. RAC-GS exam evaluates the knowledge and skills of regulatory professionals in areas such as global regulatory strategy, regional regulatory requirements, and international regulatory compliance.
RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope |
| Exam Number: | RAC-GS |
| Real Exam Qty: | Approx. 180 (divided into two parts) |
| Passing Score: | Scaled pass score set by RAPS (official pass mark not publicly published) |
| Exam Duration: | Approx. 210 (3.5 hours) |
| Related Certifications: | RAC-Drugs RAC-Devices |
| Available Languages: | English |
| Exam Format: | Multiple choice, Computer-based |
| Exam Price: | Fees vary by testing window and membership status (typically higher for non-members) |
| Sample Questions: | RAPS RAC-GS Sample Questions |
| Exam Way: | Computer-based testing at Pearson VUE centers or online proctored |
| Pre Condition: | Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS |
| Official Syllabus URL: | https://www.raps.org/certifications/rac/what-is-the-rac |
RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Regulatory Strategy and Submissions | - Regulatory submission pathways - Strategic planning for global filings |
| Product Lifecycle Management | - Post-market compliance and pharmacovigilance - Pre-market requirements |
| Country-Specific Regulations | - EU regulatory requirements - US regulatory requirements |
| Global Regulatory Environment | - Global harmonization standards (e.g., ICH, WHO) - International regulatory frameworks |
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