2023年最新のRAPS RAC-US試験問題には100問があります [Q58-Q80]

2023年最新のRAPS RAC-US試験問題には100問があります

無料で使えるRAC-US別格な問題集をダウンロード2023年07月27日に更新された100問があります

RAPS RAC-US 認定を取得することは、規制関連の業務に対するコミットメントとプロフェッショナルな成長に対する献身を示すものです。この認定は、規制当局、業界関係者、雇用主によって国際的に認められています。RAPS RAC-US 認定は、キャリアを進め、収入を増やしたい規制関連の専門家にとって貴重な資格です。

RAPS RAC-US（Regulatory Affairs Certification（RAC）US）認定試験は、医療業界で働く規制専門家向けのグローバルに認知された認定プログラムです。この認定は、規制専門家の最大のグローバル組織であるRegulatory Affairs Professionals Society（RAPS）によって提供されます。RAPS RAC-US認定試験は、米国の医療業界で働く規制専門家の知識とスキルをテストするように設計されています。

質問 # 58
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 # 59
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. Arrange for an inspection without all intended personnel.
B. Insist that key personnel be available for the inspection.
C. Inform the authority that the time is not suitable and request a new time
D. Negotiate with colleagues and the authority to find a better time.

正解：D

質問 # 60
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 major safety finding from a newly completed animal carcinogenicity study
C. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
D. A lack of efficacy with a medicinal product used in treating a life-threatening disease

正解：C

質問 # 61
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. Delay product launch until required studies are completed.
B. Educate patients and healthcare providers on how to use the product
C. Promote off-label use to a carefully selected patient population.
D. Label the product for use in appropriate populations.

正解：C

質問 # 62
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Systematic procedure to review published scientific journals
B. Systematic procedure to review experiences with the products in use
C. Vigilance procedure to ensure the full traceability of the products
D. Vigilance procedure to notify the regulatory authorities about serious incidents

正解：C

質問 # 63
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Site license
B. Export license
C. Import license
D. Product license

正解：A

質問 # 64
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 registration
B. Product requirements
C. Product stability
D. Product formulation

正解：C

質問 # 65
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

A. Send a "Dear Dr." letter to customers.
B. Assess the potential safety risk.
C. Notify the global regulatory authorities.
D. Withdraw the affected product from the markets.

正解：C

質問 # 66
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

A. Delay the start of product production.
B. Correct the label text.
C. Abort the product launch.
D. Inform the regulatory authorities.

正解：D

質問 # 67
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

A. Property
B. Formulation
C. Specification
D. Justification

正解：D

質問 # 68
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 is hospitalized for the purpose of product administration.
D. Subject's hospitalization is due to an unscheduled hip operation.

正解：C

質問 # 69
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

A. Class D
B. Class B
C. Class A
D. Class C

正解：D

質問 # 70
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. Inform Company X that it has no right to send such a letter and do nothing further.
B. Acknowledge receipt of the letter in a written response but do nothing further.
C. Inform the local regulatory authority of the letter and discuss how to respond.
D. Inform the legal department of the letter and discuss how to respond.

正解：D

質問 # 71
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A. Analytical
B. Regulatory
C. Quality
D. Production

正解：C

質問 # 72
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

A. Phase I and II clinical trials
B. Pre-clinical studies
C. Phase III clinical trials
D. Phase I clinical trials

正解：C

質問 # 73
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. Analyze the impact of the international monograph change on the local pharmacopeia.
B. Confirm that the international monograph change is not related to local pharmacopeia.
C. Prepare the international monograph change submission first and then prepare the local change when required.
D. Transfer the notice of the upcoming international monograph change to QA for further processing.

正解：D

質問 # 74
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
B. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
C. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
D. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

正解：A

質問 # 75
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

A. Safety issues
B. Clinical trial data
C. Intellectual properly
D. Marketing materials

正解：A

質問 # 76
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 # 77
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?

A. Certificate of Free Sale
B. Certificate of Analysis for the finished product
C. Certificate of GMP
D. Certificate of Pharmaceutical Product

正解：D

質問 # 78
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. Biological activity with species and/or tissue specificity
B. Proposed dose and volume of administration
C. Proposed product route and frequency of administration
D. Immunochemical and functional tests

正解：A

質問 # 79
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?