[2024年更新]RAC-USはRAC Regulatory Affairs Certificationリアルな無料試験練習テスト
無料RAC Regulatory Affairs Certification RAC-US試験問題を提供します
RAPS RAC-US認定試験は、医療産業の規制関連全般をカバーする包括的な試験です。この試験は、規制戦略、製品開発、臨床試験、規制申請、品質システム、そして市場後の活動などのトピックを扱います。この試験は、米国の規制および規制要件に関する候補者の知識、およびその知識を実践的な場面で適用する能力をテストするよう設計されています。
RAC-US認定試験は、米国の規制専門家の知識とスキルをテストするために設計された厳格な試験です。これは、規制戦略、コンプライアンス、品質システム、法的および倫理的問題など、規制業務に関連するさまざまなトピックをカバーする多肢選択式の質問で構成されています。この試験は、候補者が、医療製品の開発、製造、および商業化に関与する規制要件とプロセスを包括的に理解できるように設計されています。
質問 # 55
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. Deleting a drug substance
- D. Introducing a new analytical method
正解：B
質問 # 56
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. Initiate a mandatory recall of the product in Country Y.
- C. Review alt distribution records and complaints reported in Country Y.
- D. Draft a formal letter to customers in Country Y about this recall.
正解：C
質問 # 57
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Documented agreement
- C. Follow-up meeting after submission
- D. Early collaboration
正解：A
質問 # 58
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- B. A major safety finding from a newly completed animal carcinogenicity study
- C. A statistically significant increase in the number of deaths in an animal dose finding study
- D. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
正解：D
質問 # 59
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
- A. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
- B. Contact the regulatory authority that issued this request and discuss the requirement.
- C. Consult with colleagues about the request.
- D. Initiate testing immediately to ensure compliance.
正解：B
質問 # 60
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. Delay product launch until required studies are completed.
- C. Educate patients and healthcare providers on how to use the product
- D. Label the product for use in appropriate populations.
正解：A
質問 # 61
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 # 62
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Request documentation from the sub-contractor.
- B. Ask the vendor to take responsibility.
- C. Request an inspection from a regulatory authority.
- D. Document and perform audits.
正解：D
質問 # 63
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 design patents in target countries.
- B. Use the community patent system.
- C. File patents of interest in target countries.
- D. Use the Madrid system.
正解：C
質問 # 64
Why is it necessary to run supplemental safety pharmacology studies?
- A. To substitute the utilization of GLP
- B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- C. To comply with regulatory authority requirements related to clinical studies
- D. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
正解：D
質問 # 65
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. Notify the regulatory authority.
- B. Recommend an immediate product recall.
- C. Compare the approved text with the product label
- D. Inform the production team.
正解：C
質問 # 66
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
- A. Qualify another supplier and execute a supplier agreement.
- B. Review the company's existing Quality Management System
- C. Reformulate the products with a replacement material.
- D. Complete a gap analysis to identify options.
正解：A
質問 # 67
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：B
質問 # 68
The requirements for document control are located in which of the following documents?
- A. ICH guidelines
- B. IEC 60601
- C. ISO 13485
- D. WHO guidelines
正解：C
質問 # 69
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk evaluation
- B. Risk reduction
- C. Risk analysis
- D. Risk acceptance
正解：D
質問 # 70
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- B. Perform either an identification study or a non-clinical qualification study.
- C. Perform both identification and non-clinical qualification studies concurrently.
- D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
正解：D
質問 # 71
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 # 72
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RAPS RAC-USリアルな問題と知能問題集：https://www.goshiken.com/RAPS/RAC-US-mondaishu.html
RAC-US問題集でRAC Regulatory Affairs Certification高確率練習問題集：https://drive.google.com/open?id=17o9y2Vec81XsTxEMsl0EUUKHW7xOQ7vK