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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q52-Q57):

NEW QUESTION # 52
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

  • A. Consult with colleagues about the request.
  • B. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
  • C. Initiate testing immediately to ensure compliance.
  • D. Contact the regulatory authority that issued this request and discuss the requirement.

Answer: D


NEW QUESTION # 53
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

  • A. Physical processing and packaging
  • B. Production of Intermediate(s)
  • C. Introduction of the API starting material
  • D. Isolation and purification

Answer: A


NEW QUESTION # 54
Why is it necessary to run supplemental safety pharmacology studies?

  • A. To substitute the utilization of GLP
  • B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
  • C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
  • D. To comply with regulatory authority requirements related to clinical studies

Answer: C


NEW QUESTION # 55
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 company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
  • B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
  • C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
  • D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

Answer: B


NEW QUESTION # 56
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

Answer: B


NEW QUESTION # 57
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