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Passing Score, Duration, No of question, languages, Format of the RAPS RAC-US Certification Exam
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- Exam Format: Multiple choice
- Languages: English
- No. of questions: 100
- Passing score: 70%
- Duration: 02 Hours
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Following is the prerequisite for the RAPS RAC-US Certification Exam:
- You should have a Bachelor's degree or higher
- You must be a member of RAPS, the Regulatory Affairs Professionals Society
- You must have 3 to 5 years of experience in regulatory affairs.
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RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Reporting obligations and adverse events - Post-marketing surveillance and pharmacovigilance - Compliance and continuous improvement |
| Topic 2: Development and Pre-Market | 28% | - Labeling and advertising regulations - Design controls and technical documentation - Clinical trials and non-clinical studies - CMC and manufacturing requirements |
| Topic 3: Strategic Planning | 24% | - Risk management and quality systems - Regulatory pathways and marketing authorization - Product lifecycle strategy - US regulatory environment and framework |
| Topic 4: Submissions and Regulatory Interactions | 24% | - Modifications, supplements, and variations - Regulatory intelligence and planning - FDA review processes and communications - eCTD and electronic submission formats |
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