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

문제1

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

문제2

Which of the following BEST describes the purpose of the ICH?

A. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions

B. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions

C. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

D. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions

정답: C

문제3

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

A. Subject's hospitalization is prolonged during the clinical trial.

B. Subject is hospitalized due to complications of the product administration.

C. Subject's hospitalization is due to an unscheduled hip operation.

D. Subject is hospitalized for the purpose of product administration.

정답: C,D

문제4

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

A. Compatibility and safety

B. Volume and material

C. Efficacy and material

D. Safety and efficacy

정답: A

문제5

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

A. Transfer the notice of the upcoming international monograph change to QA for further processing.

B. Analyze the impact of the international monograph change on the local pharmacopeia.

C. Confirm that the international monograph change is not related to local pharmacopeia.

D. Prepare the international monograph change submission first and then prepare the local change when required.

정답: A,D

문제6

Which of the following is NOT required to be included in a marketing application?

A. Evidence of fee payment

B. Administrative forms

C. Final printed label

D. Quality, safety, and efficacy Information

정답: A

문제7

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

D. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."

정답: D

문제8

Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

A. Deleting an ingredient of the drug product

B. Strengthening a precaution to the product labeling

C. Introducing a new analytical method

D. Deleting a drug substance

정답: B

문제9

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

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

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

D. Arrange for an inspection without all intended personnel.

정답: C

문제10

Which of the following is MOST appropriate for the purpose of lot release of biologics?

A. Quality verification

B. Safety assurance

C. Inventory control

D. Efficacy confirmation

정답: A

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

우리와 연락하기

유용한 링크

최신 업데이트