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RAPS RAC-GS exam is a certification exam for regulatory affairs professionals who work in the global pharmaceutical and medical device industries. RAC-GS exam is offered by the Regulatory Affairs Professionals Society (RAPS), which is the largest global organization dedicated to the regulation of healthcare and related products.
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RAPS RAC-GS Certification Exam is a comprehensive exam that covers a wide range of topics related to regulatory affairs. These topics include global regulatory strategy, regulatory submissions, post-approval activities, and quality systems. RAC-GS exam is designed to test the knowledge and skills of professionals who work in all areas of regulatory affairs, from entry-level to senior-level positions.
| Section | Objectives |
|---|---|
| Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
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