RAC-US 試験問題を無料オンラインアクセス

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.

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

• A.Consult with the legal department to discuss the best course of action.
• B.Review the regulatory guidelines to determine how to proceed.
• C.Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
• D.Request a meeting with the regulatory authority to discuss the application.

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

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 time frame in which the patent will expire
• D.The stability of the drug in all zone conditions

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

• A.Contact the trade association for advice.
• B.Prepare documents for the files.
• C.Communicate with the relevant internal departments.
• D.Request a permanent waiver from the new regulation.