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

質問 1

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 2

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

（A）Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

（B）Review the regulatory guidelines to determine how to proceed.

（C）Request a meeting with the regulatory authority to discuss the application.

（D）Consult with the legal department to discuss the best course of action.

正解：C 解答を投票する

質問 3

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

（A）Risk acceptance

（B）Risk analysis

（C）Risk reduction

（D）Risk evaluation

正解：A 解答を投票する

質問 4

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 5

Which of the following claims would classify an apple as a drug?

（A）"It will make you look younger."

（B）"It will satisfy hunger."

（C）"It will whiten teeth."

（D）"It will prevent colds."

正解：D 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

At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

（A）Acknowledge receipt of the letter in a written response but do nothing further.

（B）Inform the legal department of the letter and discuss how to respond.

（C）Inform the local regulatory authority of the letter and discuss how to respond.

（D）Inform Company X that it has no right to send such a letter and do nothing further.

正解：B 解答を投票する

質問 8

Why is it necessary to run supplemental safety pharmacology studies?

（A）To comply with regulatory authority requirements related to clinical studies

（B）To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

（C）To substitute the utilization of GLP

（D）To provide adverse reaction reports and the results of the statistical data to the regulatory authority

正解：B 解答を投票する

質問 9

A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

（A）Inform the company's senior management and arrange an emergency meeting

（B）Arrange for additional testing of the product at the testing facility.

（C）Consult with the company's legal department regarding options.

（D）Obtain a copy of the proposed regulation and analyze the impact.

正解：D 解答を投票する

質問 10

Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

（A）Clinical trial data

（B）Safety issues

（C）Intellectual properly

（D）Marketing materials

正解：B 解答を投票する

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

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