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  • No. of questions: 100
  • Passing score: 70%
  • Languages: English
  • Exam Format: Multiple choice
  • Duration: 02 Hours

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Details of the RAPS RAC-US Certification Exam

RAPS RAC-US Exam Syllabus Topics:

SectionObjectives
Quality Systems and Regulatory Operations- Inspections and regulatory audits
- GxP systems (GMP, GCP, GLP)
Postmarket Compliance- Pharmacovigilance and adverse event reporting
- Device vigilance and recalls
Premarket Requirements- Labeling and promotional compliance
- Marketing authorization pathways (NDA, ANDA, PMA, 510(k))
Product Development Lifecycle- Clinical trial frameworks and submissions (IND/IDE)
- Drug and device development stages
Regulatory Foundations- Regulatory ethics and compliance principles
- US regulatory structure and agencies (FDA overview)

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