更新された検証済みのRAC-US問題集と解答には100%一発合格保証問題集はここ
合格RAC Regulatory Affairs Certification RAC-US試験問題には100問があります
質問 39
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
正解: A
質問 40
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
- A. Late and/or incorrect deliverables
- B. Adverse environmental impacts
- C. Causes of non-conformities
- D. Inadequate training
正解: C
質問 41
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 3
- B. Module 2
- C. Module 1
- D. Module 4
正解: B
質問 42
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through a product-specific meeting
- B. After the enactment of the regulation, through the industry representative
- C. Before the enactment of the regulation, through formal comments gathering process
- D. Before the enactment of the regulation, through the industry representative
正解: C
質問 43
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. Advise the senior management to send a "Dear Dr." letter.
- B. No action is required since it is an off-label use.
- C. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
- D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
正解: C
質問 44
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. Label the product for use in appropriate populations.
- C. Educate patients and healthcare providers on how to use the product
- D. Delay product launch until required studies are completed.
正解: A
質問 45
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 B
- C. Class C
- D. Class D
正解: C
質問 46
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. Initiate a global submission process after all submission data are finalized.
- B. Identify countries where special requirements exist during the product development phase.
- C. Plan regulatory approval update meetings with senior management and stakeholders.
- D. Utilize the STED template to complete global requirements.
正解: B
質問 47
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Prepare the legal team in Country Y for possible litigations.
- B. Review alt distribution records and complaints reported in Country Y.
- C. Draft a formal letter to customers in Country Y about this recall.
- D. Initiate a mandatory recall of the product in Country Y.
正解: B
質問 48
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A statistically significant increase in the number of deaths in an animal dose finding study
- B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- C. A major safety finding from a newly completed animal carcinogenicity study
- D. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
正解: D
質問 49
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
- A. Product stability
- B. Product requirements
- C. Product registration
- D. Product formulation
正解: A
質問 50
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
- A. The device incorporates well-established technology that is already present in the market.
- B. The manufacturer's experience level with the type of IVD medical device is limited.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
- D. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
正解: B
質問 51
Which term does NOT describe the same concept as the others?
- A. Follow-on protein products
- B. Monoclonal antibody
- C. Subsequent entry biologics
- D. Biosimilars
正解: B
質問 52
Which of the following is NOT required to be included in a marketing application?
- A. Evidence of fee payment
- B. Administrative forms
- C. Quality, safety, and efficacy Information
- D. Final printed label
正解: A
質問 53
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. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- C. In vitro studies show the product to be superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
正解: B
質問 54
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
- A. All senior management from the main office
- B. The minimum number of attendees necessary to address the issues
- C. As many as required by international standards
- D. As many as government attendees
正解: B
質問 55
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
- A. Cross-over
- B. Dose-ranging
- C. Placebo-controlled
- D. Active-controlled
正解: A
質問 56
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Compatibility and safety
- B. Efficacy and material
- C. Safety and efficacy
- D. Volume and material
正解: A
質問 57
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
- A. Acknowledge receipt of the letter in a written response but do nothing further.
- B. Inform the local regulatory authority of the letter and discuss how to respond.
- C. Inform the legal department of the letter and discuss how to respond.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
正解: C
質問 58
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