2023年12月 RAPS RAC-US実際の問題とブレーン問題集
RAC-US合格させる問題集でRAPS24時間で試験合格できます
RAC-US認定試験を受ける資格を得るには、候補者は規制問題または関連分野で少なくとも3年の経験があり、関連する学問の学士号または高度な学位を取得する必要があります。この試験は、ヘルスケア業界の規制専門家をサポートするグローバルメンバーシップ組織である規制業務専門家協会（RAPS）によって管理されています。 RAPS RAC-US認定試験は、規制問題の分野の主要な資格として認識されています。
質問 # 19
Which of the following is NOT required to be included in a marketing application?
- A. Quality, safety, and efficacy Information
- B. Administrative forms
- C. Final printed label
- D. Evidence of fee payment
正解：D
質問 # 20
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Quality by design analysis
- B. Fishbone analysis
- C. Failure modes, effects, and criticality analysis
- D. Fault tree analysis
正解：C
質問 # 21
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?
- A. 30c C and 65% RH
- B. 30 C and 35% RH
- C. 30: C and 75% RH
- D. 25: C and 60% RH
正解：C
質問 # 22
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Clinical experience
- B. Adverse event reports
- C. Literature search
- D. Clinical investigations
正解：D
質問 # 23
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 product route and frequency of administration
- B. Biological activity with species and/or tissue specificity
- C. Proposed dose and volume of administration
- D. Immunochemical and functional tests
正解：B
質問 # 24
Which term does NOT describe the same concept as the others?
- A. Biosimilars
- B. Monoclonal antibody
- C. Follow-on protein products
- D. Subsequent entry biologics
正解：B
質問 # 25
A process is ultimately validated to ensure which of the following?
- A. The process meets the quality system requirements.
- B. The process consistently meets the desired Quantity standards
- C. The process consistently produces the desired results.
- D. The process meets the regulatory requirements.
正解：C
質問 # 26
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. Results of a three-year, post-market patient survey indicate the product is superior.
- C. In vitro studies show the product to be superior.
- D. Government survey data indicate the product is superior.
正解：A
質問 # 27
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. Consult with the legal department to discuss the best course of action.
- D. Request a meeting with the regulatory authority to discuss the application.
正解：D
質問 # 28
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Is the product better than currently available alternatives?"
- B. "Has the product been approved for mor&4nan 10 years?"
- C. "Is the product an established gold standard?"
- D. "Is the product profitable for the manufacturer?"
正解：A
質問 # 29
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Initiate a global submission process after all submission data are finalized.
- C. Utilize the STED template to complete global requirements.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
正解：A
質問 # 30
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?
- A. File patents of interest in target countries.
- B. Use the community patent system.
- C. Use the Madrid system.
- D. File design patents in target countries.
正解：A
質問 # 31
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
- A. Approved indications of the drug
- B. Determination of product design deliverables
- C. Guidance documents for the device
- D. Determination of primary mode of action
正解：B
質問 # 32
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. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
- B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
- 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 information to provide at this time because we have already provided everything needed to support our product's approval."
正解：B
質問 # 33
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A major safety finding from a newly completed animal carcinogenicity study
- B. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR - C. A statistically significant increase in the number of deaths in an animal dose finding study
- D. A lack of efficacy with a medicinal product used in treating a life-threatening disease
正解：B
質問 # 34
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