RAC-US無料問題集「RAPS Regulatory Affairs Certification (RAC) US」

質問 1

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

（A）Plan regulatory approval update meetings with senior management and stakeholders.

（B）Initiate a global submission process after all submission data are finalized.

（C）Identify countries where special requirements exist during the product development phase.

（D）Utilize the STED template to complete global requirements.

正解：C 解答を投票する

質問 2

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

正解：D 解答を投票する

質問 3

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?

（A）Formulation

（B）Specification

（C）Justification

（D）Property

正解：C 解答を投票する

質問 4

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

（A）Government survey data indicate the product is superior.

（B）In vitro studies show the product to be superior.

（C）Results of a three-year, post-market patient survey indicate the product is superior.

（D）Results of adequate, well-controlled comparative clinical trial show the product is superior.

正解：D 解答を投票する

質問 5

During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

（A）Terminate the PI and inform the regulatory authorities.

（B）Inform the institution that granted a medical license to the Pi.

（C）Increase the frequency of monitoring visits.

（D）Send a letter of complaint to the Ethics Committee that approved the site.

正解：A 解答を投票する

質問 6

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）"We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."

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

（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."

正解：A 解答を投票する

質問 7

Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

（A）A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation

（B）A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

（C）A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

（D）A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

正解：A 解答を投票する

質問 8

The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

（A）Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.

（B）Ask that the regulatory authority provide the actual product subject to the complaint.

（C）Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release.

（D）Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.

正解：D 解答を投票する

質問 9

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）Compare the approved text with the product label

（B）Recommend an immediate product recall.

（C）Notify the regulatory authority.

（D）Inform the production team.

正解：A 解答を投票する

質問 10

Who has the PRIMARY responsibility for recall of products with quality defects?

（A）Regulatory authority

（B）Consumer

（C）Distributor

（D）Manufacturer

正解：D 解答を投票する

RAC-US 無料問題集「RAPS Regulatory Affairs Certification (RAC) US」

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