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A 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.

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RAPS RAC-US Exam Syllabus Topics:

SectionObjectives
Premarketing- Product development and approval
  • 1. Clinical and nonclinical requirements
  • 2. Submission preparation
  • 3. Labeling requirements
  • 4. FDA interactions
Strategic Planning- Regulatory strategy development
  • 1. Regulatory pathway selection
  • 2. Product development strategy
  • 3. Risk-benefit assessment
Interfacing with Regulatory Agencies- Regulatory communication and negotiation
  • 1. Meetings with regulators
  • 2. Responses to agency inquiries
  • 3. Compliance management
Post-Approval and Lifecycle Management- Marketed product compliance
  • 1. Inspections and audits
  • 2. Product changes and supplements
  • 3. Postmarket surveillance
  • 4. Adverse event reporting

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