RAPS RAPS Certifications RAC-US Questions & Answers

• Question 71:

  Which of the following is the PRIMARY purpose of an audit report?

  A. To carry out a complete review of product applications

  B. To define how to prepare new product submissions

  C. Todocument compliance history

  D. To train sales representatives

  Correct Answer: C

• Question 72:

  According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

  A. 3

  B. 5

  C. 10

  D. 15

  Correct Answer: BCD

• Question 73:

  One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

  A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

  B. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."

  C. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

  D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

  Correct Answer: B

• Question 74:

  At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

  A. Quality improvement

  B. Quality assurance

  C. Clinical affairs

  D. Regulatory agency

  Correct Answer: B

• Question 75:

  In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

  A. Potential clinical sites for the Phase III clinical trial

  B. Regulatory requirements for labeling and packaging

  C. Capacity of the manufacturing facilities to fully produce the new product

  D. Previous actions taken by regulatory authorities on similar products

  Correct Answer: D

• Question 76:

  Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

  A. "Product X is a guaranteed cure for arthritis."

  B. "Product X is effective for the treatment of arthritis."

  C. "Product X is safe for arthritis and without side effects."

  D. "Product X is effective in all patients with arthritis."

  Correct Answer: B

• Question 77:

  After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

  A. Add a warning in the IFU.

  B. Discontinue the project.

  C. Perform another risk-benefit analysis.

  D. Redesign the device.

  Correct Answer: D

• Question 78:

  The safety database for an anti-hypertensive drug consists of the following: 461 patients exposed for three months 343 patients exposed for six months 112 patients exposed for nine months 74 patients exposed for 12 months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

  A. 100 patients for 12 months

  B. 200 patients for nine months

  C. 500 patients for three months

  D. 3.000 total patient exposures

  Correct Answer: A

• Question 79:

  A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

  A. Recommend an immediate product recall.

  B. Compare the approved text with the product label

  C. Notify the regulatory authority.

  D. Inform the production team.

  Correct Answer: B

• Question 80:

  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

  Correct Answer: BC