[2024年01月18日]RAC-US試験問題集で100%合格率RAC-US試験！ [Q24-Q49]

[2024年01月18日]RAC-US試験問題集で100%合格率RAC-US試験！

試験問題集リアルRAC Regulatory Affairs Certification問題集100解答を試そう！

Regulatory Affairs Certification（RAC）USは、規制分野での知識と専門知識を検証したい規制専門家向けに設計された試験です。この試験は、規制専門職を促進し、規制産業を進展させることを目的とした国際的な組織であるRegulatory Affairs Professionals Society（RAPS）によって提供されています。 RAC-US認定は、世界的に認められ、規制分野の雇用主に高く評価されています。

RAC-US認定試験は、製品開発、規制申請、コンプライアンス、ポストマーケット監視など、広範な規制トピックをカバーしています。この試験は2つのパートに分かれており、第1部は規制アフェアの基礎に焦点を当て、第2部はより高度なトピックをカバーしています。この試験は、候補者の規制アフェアに関する知識、スキル、能力をテストし、規制コミュニティが設定した高い基準を満たすことを確認するように設計されています。

質問 # 24
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A. Early collaboration
B. Frequent communication
C. Follow-up meeting after submission
D. Documented agreement

正解：B

質問 # 25
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

A. "Product X is effective for the treatment of arthritis."
B. "Product X is effective in all patients with arthritis."
C. "Product X is a guaranteed cure for arthritis."
D. "Product X is safe for arthritis and without side effects."

正解：A

質問 # 26
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Quality and effectiveness
B. Quality and failure risk
C. Safety and failure risk
D. Safety and effectiveness

正解：D

質問 # 27
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

A. Inform the company's senior management and arrange an emergency meeting
B. Obtain a copy of the proposed regulation and analyze the impact.
C. Consult with the company's legal department regarding options.
D. Arrange for additional testing of the product at the testing facility.

正解：B

質問 # 28
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

A. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

正解：B

質問 # 29
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 an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
C. Perform both identification and non-clinical qualification studies concurrently.
D. Perform either an identification study or a non-clinical qualification study.

正解：B

質問 # 30
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

A. The ISO technical committee in charge of the area
B. The country's regulatory authority
C. The ISO Secretariat
D. The ISO national member body

正解：D

質問 # 31
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

A. Summarize regulatory documents and history and provide the information to the management team.
B. Ask the trade association representative to provide an overview of the new product area to the marketing team.
C. Obtain regulatory documents and history and provide the information to R&D.
D. Obtain competitor research and provide the information to the management team.

正解：A

質問 # 32
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A. Develop documented procedures for regulatory compliance processes and train personnel.
B. Train all new employees on regulatory compliance processes and assign a mentor to them.
C. Train employees on all regulatory compliance processes using state-of-the-art systems.
D. Document any failure to follow regulatory compliance processes in employee performance reviews.

正解：A

質問 # 33
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. Complete a gap analysis to identify options.
B. Review the company's existing Quality Management System
C. Reformulate the products with a replacement material.
D. Qualify another supplier and execute a supplier agreement.

正解：D

質問 # 34
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. Inform the regulatory authorities.
C. Abort the product launch.
D. Correct the label text.

正解：B

質問 # 35
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. Negotiate with colleagues and the authority to find a better time.
B. Insist that key personnel be available for the inspection.
C. Arrange for an inspection without all intended personnel.
D. Inform the authority that the time is not suitable and request a new time

正解：A

質問 # 36
Which of the following is MOST appropriate for the purpose of lot release of biologics?

A. Efficacy confirmation
B. Quality verification
C. Inventory control
D. Safety assurance

正解：B

質問 # 37
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A. Scope and level of detail
B. Expiration date
C. Relevance to regulations
D. Revision history

正解：C

質問 # 38
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Product release and validation
B. Early technical design and product release
C. Concept development and validation
D. Concept development and early technical design

正解：D

質問 # 39
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 # 40
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

A. Doha Declaration in the TRIPS Agreement
B. International import and export regulations
C. The stability of the drug in all zone conditions
D. The time frame in which the patent will expire

正解：C

質問 # 41
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 # 42
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 legal department of the letter and discuss how to respond.
C. Inform the local regulatory authority 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：B

質問 # 43
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. Confirm that the international monograph change is not related to local pharmacopeia.
B. Prepare the international monograph change submission first and then prepare the local change when required.
C. Analyze the impact of the international monograph change on the local pharmacopeia.
D. Transfer the notice of the upcoming international monograph change to QA for further processing.

正解：D

質問 # 44
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

A. Inform the institution that granted a medical license to the Pi.
B. Send a letter of complaint to the Ethics Committee that approved the site.
C. Terminate the PI and inform the regulatory authorities.
D. Increase the frequency of monitoring visits.

正解：C

質問 # 45
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Written procedure for product traceability
B. Training program for sales people
C. Local reimbursement requirements
D. Service operation procedures

正解：B

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. Utilize the STED template to complete global requirements.
B. Initiate a global submission process after all submission data are finalized.
C. Plan regulatory approval update meetings with senior management and stakeholders.
D. Identify countries where special requirements exist during the product development phase.

正解：D

質問 # 47
A process is ultimately validated to ensure which of the following?

A. The process meets the regulatory requirements.
B. The process consistently produces the desired results.
C. The process meets the quality system requirements.
D. The process consistently meets the desired Quantity standards

正解：B

質問 # 48
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?