RAC Past Papers

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Pass Regulatory Affairs Certification (RAC)
Global Scope exam in just 24 HOURS! 100 REAL
EXAM QUESTIONS ANSWERS Regulatory Affairs
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• Sample Questions
• Question 1
• Which of the following statements regarding the
  off-label use of drugs is CORRECT?
• Although the regulatory authority reviews and
  approves drugs for specific indications, the
  approval does not limit the use of those drugs in
  clinical practice.
• The regulatory authority does not restrict
  physician prescribing for off-label
• indications or regulate the manufacturer's
  promotion for such use.
• 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.
• The peer-reviewed literature can ensure
  high-quality off-label promotion of medications,
  thereby increasing access to much needed drugs
  and devices.
• Answer A
• Question 2
• A drug product presents degradation during the
  manufacturing process. In addition to the
  amount, what information should be provided FIRST
  in order to use API overage?
• Specification
• Formulation
• Property
• Justification
• Answer D
• Question 3

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• requirement and received approval. Which action
  should the regulatory affairs professional take
  FIRST?
• Discuss with the regulatory apriority and attempt
  to reach an acceptable solution.
• Inform the internal departments to redesign the
  product to comply with this requirement.
• Inform the regulatory authority that such a
  requirement is not applicable to the product.
• Notify senior management that the product cannot
  be registered.
• Answer A
• Question 4
• Which of the following statements regarding
  export regulations for an approved product is
  CORRECT?
• The product must not be in accord with the
  specifications of the foreign purchaser.
• The product must not be in conflict with the laws
  of the country to which it is intended for
  export.
• The product must not be labeled on the outside of
  the shipping package that it is intended for
  export.
• The product must not be sold or offered for sale
  in domestic commerce.
• Answer B
• Question 5
• The intermediate manufacturing process was
  changed during development of a pharmaceutical.
  The change may impact the API specification.
  Which functional area is responsible for the
  final approval of the change?
• Production
• Analytical

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• Question 6
• Under which of the following circumstances would
  a regulatory authority require a more detailed
  premarket submission, a more rigorous audit,
  and/or the provision of more performance
  evaluation data than would normally apply to an
  IVD device of that risk class?
• The device is an updated version of a compliant
  device from the same manufacturer and contains
  no substantive change.
• Internationally recognized standards are
  available to cover the main aspects of the
  device and have been used by the manufacturer.
• The manufacturer's experience level with the type
  of IVD medical device is limited.
• The device incorporates well-established
  technology that is already present in the
  market.
• Answer C
• Question 7
• According to WHO, what are the temperature and
  humidity conditions for a Zone IVb long term
  stability study?
• 25 C and 60 RH
• 30 C and 35 RH
• 30c C and 65 RH
• 30 C and 75 RH
• Answer D
• Question 8

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• any regulatory action." Which action would be the
  most appropriate FIRST step for the company to
  take?
• Contact the regulatory authority to argue that
  its conclusions are wrong.
• Contact the regulatory authority to discuss its
  findings.
• Repeat the Hepatotoxicity tests and send the
  results to the regulatory authority.
• Wait for the regulatory authority's final
  publication on its findings.
• Answer B

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