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

1. 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) Arrange for additional testing of the product at the testing facility.
B) Consult with the company's legal department regarding options.
C) Obtain a copy of the proposed regulation and analyze the impact.
D) Inform the company's senior management and arrange an emergency meeting

2. 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) Product distribution
B) Plasma fractionation
C) Plasma pooling
D) Individual plasma donation

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. Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A) Vigilance procedure to ensure the full traceability of the products
B) Systematic procedure to review published scientific journals
C) Vigilance procedure to notify the regulatory authorities about serious incidents
D) Systematic procedure to review experiences with the products in use

5. The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A) Regulatory
B) Analytical
C) Quality
D) Production

問題與答案：