RAC-US試験無料問題集（100題）「RAPS Regulatory Affairs Certification (RAC) US 認定」

出題：1

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A. Proposed dose and volume of administration

B. Biological activity with species and/or tissue specificity

C. Immunochemical and functional tests

D. Proposed product route and frequency of administration

正解：B 解答を投票する

出題：2

Why is it necessary to run supplemental safety pharmacology studies?

A. To provide adverse reaction reports and the results of the statistical data to the regulatory authority

B. To substitute the utilization of GLP

C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

D. To comply with regulatory authority requirements related to clinical studies

正解：C 解答を投票する

出題：3

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 adequate, well-controlled comparative clinical trial show the product is superior.

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

正解：C 解答を投票する

出題：4

The requirements for document control are located in which of the following documents?

A. WHO guidelines

B. ISO 13485

C. IEC 60601

D. ICH guidelines

正解：B 解答を投票する

出題：5

According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

A. Class A

B. Class D

C. Class C

D. Class B

正解：C 解答を投票する

出題：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 because we have already provided everything needed to support our product's approval."

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

D. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

正解：C 解答を投票する

出題：7

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

A. Fishbone analysis

B. Failure modes, effects, and criticality analysis

C. Fault tree analysis

D. Quality by design analysis

正解：B 解答を投票する

出題：8

A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

A. Submit the product for review as a pharmaceutical product in Country Y.

B. Examine decisions made about similar products in Country Y to propose the classification of the product.

C. Apply for review of the additional part of the product as a pharmaceutical product in Country

D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

正解：C 解答を投票する

出題：9

A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

A. Insist that key personnel be available for the inspection.

B. Negotiate with colleagues and the authority to find a better time.

C. Arrange for an inspection without all intended personnel.

D. Inform the authority that the time is not suitable and request a new time

正解：B 解答を投票する

出題：10

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Regulatory agency

B. Quality assurance

C. Quality improvement

D. Clinical affairs

正解：B 解答を投票する

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