최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope

문제1

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Quality and failure risk

B. Safety and effectiveness

C. Safety and failure risk

D. Quality and effectiveness

정답: B

문제2

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

B. Notify senior management that the product cannot be registered.

C. Inform the internal departments to redesign the product to comply with this requirement.

D. Inform the regulatory authority that such a requirement is not applicable to the product.

정답: A

문제3

According to WHO,what are the temperature and humidity conditions for a Zone IVb long-term stability study?

A. 30c C and 35% RH

B. 30: C and 75% RH

C. 25: C and 60% RH

D. 30c C and 65% RH

정답: B

문제4

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. Recommend an immediate product recall.

B. Notify the regulatory authority.

C. Inform the production team.

D. Compare the approved text with the product label

정답: D

문제5

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. Increase the frequency of monitoring visits.

B. Terminate the PI and inform the regulatory authorities.

C. Send a letter of complaint to the Ethics Committee that approved the site.

D. Inform the institution that granted a medical license to the Pi.

정답: B

문제6

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

A. Hazard and operability study

B. ISO 14971 risk analysis

C. Fault tree analysis

D. Failure mode and effect analysis

정답: B

문제7

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

B. Advise the senior management to send a "Dear Dr." letter.

C. No action is required since it is an off-label use.

D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

정답: A

문제8

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

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

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

C. Government survey data indicate the product is superior.

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

정답: A

문제9

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A. Document any failure to follow regulatory compliance processes in employee performancereviews.

B. Develop documented procedures for regulatory compliance processes and train personnel.

C. Train employees on all regulatory compliance processes using state-of-the-art systems.

D. Train all new employees on regulatory compliance processes and assign a mentor to them.

정답: B

문제10

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

A. Isolation and purification

B. Physical processing and packaging

C. Production of Intermediate(s)

D. Introduction of the API starting material

정답: B

최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope

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