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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q88-Q93):

NEW QUESTION # 88
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 labeled on the outside of the shipping package that it is intended for export.
  • C. The product must not be in conflict with the laws of the country to which it is intended for export.
  • D. The product must not be sold or offered for sale in domestic commerce.

Answer: C


NEW QUESTION # 89
What is the LAST stage in the development of a quality risk management process for a medical device?

  • A. Risk acceptance
  • B. Risk reduction
  • C. Risk analysis
  • D. Risk evaluation

Answer: A


NEW QUESTION # 90
In which section of the ICH Common Technical Document will the overview of clinical data appear?

  • A. Module 2
  • B. Module 1
  • C. Module 3
  • D. Module 4

Answer: A


NEW QUESTION # 91
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  • A. Doha Declaration in the TRIPS Agreement
  • B. The stability of the drug in all zone conditions
  • C. International import and export regulations
  • D. The time frame in which the patent will expire

Answer: B


NEW QUESTION # 92
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

  • A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
  • B. Perform both identification and non-clinical qualification studies concurrently.
  • C. Perform either an identification study or a non-clinical qualification study.
  • D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

Answer: D


NEW QUESTION # 93
......

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