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RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Strategic Planning | 24% | - US regulatory environment and framework - Risk management and quality systems - Product lifecycle strategy - Regulatory pathways and marketing authorization |
| Topic 2: Submissions and Regulatory Interactions | 24% | - Regulatory intelligence and planning - eCTD and electronic submission formats - Modifications, supplements, and variations - FDA review processes and communications |
| Topic 3: Post-Market and Compliance | 24% | - Post-marketing surveillance and pharmacovigilance - Inspections, audits, and enforcement actions - Compliance and continuous improvement - Reporting obligations and adverse events |
| Topic 4: Development and Pre-Market | 28% | - Labeling and advertising regulations - Design controls and technical documentation - Clinical trials and non-clinical studies - CMC and manufacturing requirements |
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