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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 Regulatory Affairs Certification (RAC) US Sample Questions (Q17-Q22):

NEW QUESTION # 17
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

  • A. Arrange for additional testing of the product at the testing facility.
  • B. Obtain a copy of the proposed regulation and analyze the impact.
  • C. Consult with the company's legal department regarding options.
  • D. Inform the company's senior management and arrange an emergency meeting

Answer: B


NEW QUESTION # 18
The requirements for document control are located in which of the following documents?

  • A. WHO guidelines
  • B. ISO 13485
  • C. IEC 60601
  • D. ICH guidelines

Answer: B


NEW QUESTION # 19
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

  • A. Three years after the last clinical study site was supplied with investigational drugs
  • B. For at least two years after the last approval of an application in an ICH region
  • C. For a minimum of 10 years after completion of the clinical study
  • D. Until the product has been discontinued from marketing in all ICH regions

Answer: B


NEW QUESTION # 20
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

  • A. Increase the frequency of monitoring visits.
  • B. Inform the institution that granted a medical license to the Pi.
  • C. Terminate the PI and inform the regulatory authorities.
  • D. Send a letter of complaint to the Ethics Committee that approved the site.

Answer: C


NEW QUESTION # 21
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

  • A. Formulation
  • B. Property
  • C. Specification
  • D. Justification

Answer: D


NEW QUESTION # 22
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