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質問 48
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 local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
- B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
- C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
- D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
正解: B
質問 49
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Systematic procedure to review published scientific journals
- B. Vigilance procedure to ensure the full traceability of the products
- C. Systematic procedure to review experiences with the products in use
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
正解: B
質問 50
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 51
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
- A. Submit the product for review as a pharmaceutical product in Country Y.
- B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
- C. Apply for review of the additional part of the product as a pharmaceutical product in Country
- D. Examine decisions made about similar products in Country Y to propose the classification of the product.
正解: C
質問 52
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Consumer
- B. Distributor
- C. Regulatory authority
- D. Manufacturer
正解: D
質問 53
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. Transfer the notice of the upcoming international monograph change to QA for further processing.
- C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Prepare the international monograph change submission first and then prepare the local change when required.
正解: B
質問 54
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. The stability of the drug in all zone conditions
- B. The time frame in which the patent will expire
- C. International import and export regulations
- D. Doha Declaration in the TRIPS Agreement
正解: A
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. Dose-ranging
- B. Cross-over
- C. Placebo-controlled
- D. Active-controlled
正解: B
質問 56
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Product license
- B. Site license
- C. Export license
- D. Import license
正解: B
質問 57
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will whiten teeth."
- C. "It will satisfy hunger."
- D. "It will prevent colds."
正解: D
質問 58
During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?
- A. Failure mode and effect analysis
- B. Fault tree analysis
- C. ISO 14971 risk analysis
- D. Hazard and operability study
正解: C
質問 59
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR - B. A statistically significant increase in the number of deaths in an animal dose finding study
- C. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- D. A major safety finding from a newly completed animal carcinogenicity study
正解: A
質問 60
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Individual plasma donation
- B. Product distribution
- C. Plasma fractionation
- D. Plasma pooling
正解: B
質問 61
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. Initiate a mandatory recall of the product in Country Y.
- B. Draft a formal letter to customers in Country Y about this recall.
- C. Review alt distribution records and complaints reported in Country Y.
- D. Prepare the legal team in Country Y for possible litigations.
正解: C
質問 62
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 manufacturer's experience level with the type of IVD medical device is limited.
- B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
- D. The device incorporates well-established technology that is already present in the market.
正解: A
質問 63
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