最新的RAPS RAC-GS免費考試真題

問題1

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A. Request that doctors stop using the product for the off-label indication.

B. Allow doctors to use the product for the off-label indication.

C. Communicate with the sales department to stop using the promotional materials.

D. Contact the marketing department to recall the product.

正確答案: C

問題2

A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

A. Obtain competitor research and provide the information to the management team.

B. Obtain regulatory documents and history and provide the information to R&D.

C. Summarize regulatory documents and history and provide the information to the management team.

D. Ask the trade association representative to provide an overview of the new product area to the marketing team.

正確答案: C

問題3

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

A. "Product X is effective for the treatment of arthritis."

B. "Product X is safe for arthritis and without side effects."

C. "Product X is a guaranteed cure for arthritis."

D. "Product X is effective in all patients with arthritis."

正確答案: A

問題4

According to ICH, how many stability time points are normally required to establish a two-year shelf life for a product?

A. 9

B. 3

C. 7

D. 5

正確答案: C

問題5

Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

B. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

C. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

D. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

正確答案: D

問題6

Which of the following statements regarding export regulations for an approved product is CORRECT?

A. The product must not be sold or offered for sale in domestic commerce.

B. The product must not be labeled on the outside of the shipping package that it is intendedfor export.

C. The product must not be in accord with the specifications of the foreign purchaser.

D. The product must not be in conflict with the laws of the country to which it is intended forexport.

正確答案: D

問題7

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

A. Introduction of the API starting material

B. Physical processing and packaging

C. Production of Intermediate(s)

D. Isolation and purification

正確答案: B

問題8

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

A. Module 3

B. Module 1

C. Module 2

D. Module 4

正確答案: A,C

問題9

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. Inform upper management immediately.

B. Resubmit the entire package.

C. Contact the legal department and ask them how to proceed.

D. Verify the procedure in the regulation for the corrections.

正確答案: D

問題10

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Product license

B. Export license

C. Import license

D. Site license

正確答案: D

最新的RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS免費考試真題

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