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