RAC-GS無料問題集「RAPS Regulatory Affairs Certification (RAC) Global Scope」

質問 1

According to ISO 14971,what is the FIRST step when developing a risk management plan for a medical device?

（A）Risk analysis

（B）Risk estimation

（C）Risk control

（D）Risk management

正解：A 解答を投票する

質問 2

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 3

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

（A）Causes of non-conformities

（B）Late and/or incorrect deliverables

（C）Inadequate training

（D）Adverse environmental impacts

正解：A 解答を投票する

質問 4

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

質問 5

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

（A）"Product X is effective in all patients with arthritis."

（B）"Product X is safe for arthritis and without side effects."

（C）"Product X is a guaranteed cure for arthritis."

（D）"Product X is effective for the treatment of arthritis."

正解：D 解答を投票する

質問 6

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

（A）Risk analysis

（B）Instructions for use

（C）Product literature

（D）Essential principles

正解：A、D 解答を投票する

質問 7

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 8

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 forexport.

（D）The product must not be labeled on the outside of the shipping package that it is intendedfor export.

正解：C 解答を投票する

質問 9

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 acounterfeit product.

（B）Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.

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

（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 10

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

（A）Promote off-label use to a carefully selected patient population.

（B）Delay product launch until required studies are completed.

（C）Label the product for use in appropriate populations.

（D）Educate patients and healthcare providers on how to use the product

正解：A 解答を投票する

RAC-GS 無料問題集「RAPS Regulatory Affairs Certification (RAC) Global Scope」

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