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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:

SectionWeightObjectives
Topic 1: Post-Market and Compliance24%- Inspections, audits, and enforcement actions
- Reporting obligations and adverse events
- Post-marketing surveillance and pharmacovigilance
- Compliance and continuous improvement
Topic 2: Development and Pre-Market28%- Labeling and advertising regulations
- Design controls and technical documentation
- Clinical trials and non-clinical studies
- CMC and manufacturing requirements
Topic 3: Strategic Planning24%- Risk management and quality systems
- Regulatory pathways and marketing authorization
- Product lifecycle strategy
- US regulatory environment and framework
Topic 4: Submissions and Regulatory Interactions24%- Modifications, supplements, and variations
- Regulatory intelligence and planning
- FDA review processes and communications
- eCTD and electronic submission formats

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