Free Access RAPS.RAC-US.v2022-06-05.q36 Practice Test (Page 3)

Question 6

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

A.Failure modes, effects, and criticality analysis

B.Fault tree analysis

C.Quality by design analysis

D.Fishbone analysis

Question 7

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.Inform the company's senior management and arrange an emergency meeting

B.Consult with the company's legal department regarding options.

C.Arrange for additional testing of the product at the testing facility.

D.Obtain a copy of the proposed regulation and analyze the impact.

Question 8

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A.Product license

B.Export license

C.Import license

D.Site license

Question 9

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.Safety-related reporting

B.Risk management process

C.Labeling

D.Regulatory application summary

Question 10

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

A."Has the product been approved for mor&4nan 10 years?"

B."Is the product better than currently available alternatives?"

C."Is the product profitable for the manufacturer?"

D."Is the product an established gold standard?"

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