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

1. 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.

2. During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

A) Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
B) Perform both identification and non-clinical qualification studies concurrently.
C) Perform either an identification study or a non-clinical qualification study.
D) Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

3. A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

A) Consult with colleagues about the request.
B) Initiate testing immediately to ensure compliance.
C) Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
D) Contact the regulatory authority that issued this request and discuss the requirement.

4. 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

5. A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?

A) Use the community patent system.
B) File patents of interest in target countries.
C) Use the Madrid system.
D) File design patents in target countries.

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