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

質問 1

The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

（A）3.000 total patient exposures

（B）500 patients for three months

（C）100 patients for 12 months

（D）200 patients for nine months

正解：C 解答を投票する

質問 2

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

正解：C 解答を投票する

質問 3

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?

（A）Analytical

（B）Regulatory

（C）Quality

（D）Production

正解：C 解答を投票する

質問 4

According to ICH, which of the following components of study information is NOT required in a clinical study report?

（A）Detailed CV of all investigators

（B）List of lECs or lRBs

（C）Randomization scheme and codes

（D）Protocol and protocol amendments

正解：A 解答を投票する

質問 5

According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

（A）3

（B）5

（C）15

（D）10

正解：B 解答を投票する

質問 6

In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

（A）Safety and efficacy

（B）Efficacy and material

（C）Volume and material

（D）Compatibility and safety

正解：D 解答を投票する

質問 7

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 8

During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

（A）Allow the auditor access to the room and records due to the current audit.

（B）Allow the auditor accompanied access to the room to retrieve the records.

（C）Deny the auditor access to the room and records due to confidentiality concerns.

（D）Deny the auditor access to the room and retrieve only the requested records.

正解：B 解答を投票する

質問 9

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

（A）Subject is hospitalized for the purpose of product administration.

（B）Subject's hospitalization is due to an unscheduled hip operation.

（C）Subject's hospitalization is prolonged during the clinical trial.

（D）Subject is hospitalized due to complications of the product administration.

正解：A 解答を投票する

質問 10

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 sold or offered for sale in domestic commerce.

（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 labeled on the outside of the shipping package that it is intended for export.

正解：C 解答を投票する

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

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