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RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
| Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Post-Market Surveillance | - Pharmacovigilance and safety reporting - Lifecycle management and variations |
| Regulatory Submissions | - Dossier preparation (eCTD and regional formats) - Global marketing authorization applications |
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