PDF Version DemoA quick overview of the RAPS RAC-US Certification Exam:
Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.
There are the topics covered by the RAPS RAC-US Certification Exam:
RAC-US exam dumps cover the following topics of the RAPS RAC-US Certification Exam:
- Pharmaceutical Regulations: 40%
- Drug Safety: 25%
- Medical Devices Regulations: 25%
- Medical Device Risk Management: 10%
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RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Development and Pre-Market | 28% | - Clinical trials and non-clinical studies - Design controls and technical documentation - Labeling and advertising regulations - CMC and manufacturing requirements |
| Topic 2: Strategic Planning | 24% | - Regulatory pathways and marketing authorization - Risk management and quality systems - US regulatory environment and framework - Product lifecycle strategy |
| Topic 3: Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Post-marketing surveillance and pharmacovigilance - Reporting obligations and adverse events - Compliance and continuous improvement |
| Topic 4: Submissions and Regulatory Interactions | 24% | - FDA review processes and communications - eCTD and electronic submission formats - Regulatory intelligence and planning - Modifications, supplements, and variations |
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