[2022年更新]RAC-USリアルな試験問題集でRAC-US練習テスト [Q51-Q67]

[2022年更新]RAC-USリアルな試験問題集でRAC-US練習テスト

RAC-US問題集でRAC Regulatory Affairs Certification高確率練習問題集

質問 51
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 because we have already provided everything needed to support our product's approval."
C. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
D. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

正解: C

質問 52
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. Justification
B. Property
C. Specification
D. Formulation

正解: A

質問 53
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. Withdraw the affected product from the markets.
B. Assess the potential safety risk.
C. Notify the global regulatory authorities.
D. Send a "Dear Dr." letter to customers.

正解: C

質問 54
Which of the following BEST describes the purpose of the ICH?

A. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
B. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
C. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
D. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

正解: A

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 a drug substance
B. Introducing a new analytical method
C. Strengthening a precaution to the product labeling
D. Deleting an ingredient of the drug product

正解: C

質問 56
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

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

正解: D

質問 57
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

A. Develop a better brand-name drug in the same class.
B. Conduct a Phase III study for a new unrelated indication of the drug.
C. Explore litigation strategy for patent infringements on the drug.
D. Develop a generic version of the drug.

正解: D

質問 58
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. As many as government attendees
B. All senior management from the main office
C. The minimum number of attendees necessary to address the issues
D. As many as required by international standards

正解: C

質問 59
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. Utilize the STED template to complete global requirements.
C. Initiate a global submission process after all submission data are finalized.
D. Plan regulatory approval update meetings with senior management and stakeholders.

正解: A

質問 60
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 country's regulatory authority
B. The ISO Secretariat
C. The ISO technical committee in charge of the area
D. The ISO national member body

正解: D

質問 61
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. Literature search
B. Adverse event reports
C. Clinical experience
D. Clinical investigations

正解: D

質問 62
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. No action is required since it is an off-label use.
B. Advise the senior management to send a "Dear Dr." letter.
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 63
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

A. Review the content of change and supporting data for the equivalency with the current material.
B. Prepare regulatory submissions that detail the medical device's change in materials.
C. Write a memo to file since the change does not impact product safety and effectiveness.
D. No action is needed in this situation.

正解: A

質問 64
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

A. Production of Intermediate(s)
B. Physical processing and packaging
C. Introduction of the API starting material
D. Isolation and purification

正解: B

質問 65
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 66
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?