RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 31:

  Which of the following BEST describes the purpose of the ICH?

  A. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
  B. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
  C. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
  D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
  D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

• Question 32:

  A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

  A. Concept development and validation
  B. Concept development and early technical design
  C. Early technical design and product release
  D. Product release and validation
  B. Concept development and early technical design

• Question 33:

  A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

  A. Plasma fractionation
  B. Product distribution
  C. Individual plasma donation
  D. Plasma pooling
  B. Product distribution

• Question 34:

  What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

  A. Ask the vendor to take responsibility.
  B. Document and perform audits.
  C. Request an inspection from a regulatory authority.
  D. Request documentation from the sub-contractor.
  B. Document and perform audits.

• Question 35:

  The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily. Which of the following actions should the regulatory affairs professional take?

  A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
  B. Ask that the regulatory authority provide the actual product subject to the complaint.
  C. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.
  D. Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.
  A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.

• Question 36:

  An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

  A. Stop product manufacturing.
  B. Establish validation procedures.
  C. Assess the impact of the changes.
  D. Review the stability data for the changes.
  A. Stop product manufacturing.
  C. Assess the impact of the changes.

• Question 37:

  According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

  A. Deficiency of a device found by the user prior to patient use
  B. Adverse event caused by patient conditions
  C. Malfunction occurring before the end of service life of the medical device
  D. Malfunction protection operated correctly
  B. Adverse event caused by patient conditions
  C. Malfunction occurring before the end of service life of the medical device

• Question 38:

  A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

  A. Labeling
  B. Regulatory application summary
  C. Risk management process
  D. Safety-related reporting
  A. Labeling

• Question 39:

  Which of the following statements regarding export regulations for an approved product is CORRECT?

  A. The product must not be in accord with the specifications of the foreign purchaser.
  B. The product must not be in conflict with the laws of the country to which it is intended forexport.
  C. The product must not be labeled on the outside of the shipping package that it is intendedfor export.
  D. The product must not be sold or offered for sale in domestic commerce.
  B. The product must not be in conflict with the laws of the country to which it is intended forexport.

• Question 40:

  Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

  A. Subject is hospitalized due to complications of the product administration.
  B. Subject is hospitalized for the purpose of product administration.
  C. Subject's hospitalization is due to an unscheduled hip operation.
  D. Subject's hospitalization is prolonged during the clinical trial.
  B. Subject is hospitalized for the purpose of product administration.
  C. Subject's hospitalization is due to an unscheduled hip operation.