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

1. Why is it necessary to run supplemental safety pharmacology studies?

A) To substitute the utilization of GLP
B) To comply with regulatory authority requirements related to clinical studies
C) To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
D) To provide adverse reaction reports and the results of the statistical data to the regulatory authority

2. Which of the following claims would classify an apple as a drug?

A) "It will prevent colds."
B) "It will whiten teeth."
C) "It will satisfy hunger."
D) "It will make you look younger."

3. What is the LAST stage in the development of a quality risk management process for a medical device?

A) Risk analysis
B) Risk acceptance
C) Risk evaluation
D) Risk reduction

4. Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

A) Clinical trial data
B) Intellectual properly
C) Marketing materials
D) Safety issues

5. Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

A) "Product X is effective in all patients with arthritis."
B) "Product X is safe for arthritis and without side effects."
C) "Product X is effective for the treatment of arthritis."
D) "Product X is a guaranteed cure for arthritis."

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