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To be eligible to take the RAC-GS exam, candidates must have at least five years of experience in regulatory affairs, with at least two years of experience in a global regulatory environment. Candidates must also have a bachelor's degree or higher from an accredited institution. Once certified, RAC-GS holders must maintain their certification by completing continuing education requirements and renewing their certification every three years.
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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.
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| Section | Objectives |
|---|---|
| Topic 1: Country-Specific Regulations | - EU regulatory requirements - US regulatory requirements |
| Topic 2: Regulatory Strategy and Submissions | - Regulatory submission pathways - Strategic planning for global filings |
| Topic 3: Product Lifecycle Management | - Pre-market requirements - Post-market compliance and pharmacovigilance |
| Topic 4: Global Regulatory Environment | - Global harmonization standards (e.g., ICH, WHO) - International regulatory frameworks |
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