RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 51:

  The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

  A. The process information and analytical result of Company X API
  B. The process information and analytical result of Company Y API
  C. The process information and the comparative analytical result of APIs from both companies
  D. Information deemed appropriate by the regulatory authority
  C. The process information and the comparative analytical result of APIs from both companies

• Question 52:

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

• Question 53:

  Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

  A. Before the enactment of the regulation, through the industry representative
  B. Before the enactment of the regulation, through formal comments gathering process
  C. After the enactment of the regulation, through the industry representative
  D. After the enactment of the regulation, through a product-specific meeting
  B. Before the enactment of the regulation, through formal comments gathering process

• Question 54:

  Which of the following statements regarding the off-label use of drugs is CORRECT?

  A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.
  B. The regulatory authority does not restrict physician prescribing for off-label indications orregulate the manufacturer's promotion for such use.
  C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
  D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing accessto much needed drugs and devices.
  A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.

• Question 55:

  In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

  A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
  B. Inform the internal departments to redesign the product to comply with this requirement.
  C. Inform the regulatory authority that such a requirement is not applicable to the product.
  D. Notify senior management that the product cannot be registered.
  A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

• Question 56:

  A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

  A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
  B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
  C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
  D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
  A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

• Question 57:

  The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

  A. Transfer the notice of the upcoming international monograph change to QA for further processing.
  B. Prepare the international monograph change submission first and then prepare the local change when required.
  C. Confirm that the international monograph change is not related to local pharmacopeia.
  D. Analyze the impact of the international monograph change on the local pharmacopeia.
  A. Transfer the notice of the upcoming international monograph change to QA for further processing.
  B. Prepare the international monograph change submission first and then prepare the local change when required.

• Question 58:

  GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

  A. Instructions for use
  B. Risk analysis
  C. Product literature
  D. Essential principles
  B. Risk analysis
  D. Essential principles

• Question 59:

  In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

  A. Local reimbursement requirements
  B. Service operation procedures
  C. Training program for sales people
  D. Written procedure for product traceability
  C. Training program for sales people

• Question 60:

  Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

  A. Document any failure to follow regulatory compliance processes in employee performancereviews.
  B. Develop documented procedures for regulatory compliance processes and train personnel.
  C. Train all new employees on regulatory compliance processes and assign a mentor to them.
  D. Train employees on all regulatory compliance processes using state-of-the-art systems.
  B. Develop documented procedures for regulatory compliance processes and train personnel.