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

1. In which section of the ICH Common Technical Document will the overview of clinical data appear?

A) Module 3
B) Module 2
C) Module 4
D) Module 1

2. 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) Reformulate the products with a replacement material.
C) Review the company's existing Quality Management System
D) Qualify another supplier and execute a supplier agreement.

3. 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

4. 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.

5. In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

A) Capacity of the manufacturing facilities to fully produce the new product
B) Potential clinical sites for the Phase III clinical trial
C) Previous actions taken by regulatory authorities on similar products
D) Regulatory requirements for labeling and packaging

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