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最新的 RAC Regulatory Affairs Certification RAC-GS 免費考試真題:

1. 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) Discuss with regulatory authorities to investigate how to have the off-label indication approved.
B) Advise the senior management to send a "Dear Dr." letter.
C) File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
D) No action is required since it is an off-label use.

2. 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?

A) Contact the legal department and ask them how to proceed.
B) Inform upper management immediately.
C) Resubmit the entire package.
D) Verify the procedure in the regulation for the corrections.

3. 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.

4. 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) Adverse event reports
B) Clinical investigations
C) Clinical experience
D) Literature search

5. Which of the following BEST describes the purpose of the ICH?

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

問題與答案：

問題 #1 答案： A

問題 #2 答案： D

問題 #3 答案： B,D

問題 #4 答案： B

問題 #5 答案： D