Free Access RAPS.RAC-US.v2022-09-26.q36 Practice Test (Page 2)

Question 1

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

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

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

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

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

Question 2

An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

A.Assess the impact of the changes.

B.Stop product manufacturing.

C.Review the stability data for the changes.

D.Establish validation procedures.

Question 3

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A.Documented agreement

B.Follow-up meeting after submission

C.Frequent communication

D.Early collaboration

Question 4

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 either an identification study or a non-clinical qualification study.

B.Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

C.Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

D.Perform both identification and non-clinical qualification studies concurrently.

Question 5

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.Inform the company's senior management and arrange an emergency meeting

B.Arrange for additional testing of the product at the testing facility.

C.Obtain a copy of the proposed regulation and analyze the impact.

D.Consult with the company's legal department regarding options.

Other Version: 1070RAPS.RAC-US.v2023-04-24.q35; 1484RAPS.RAC-US.v2022-06-05.q36; 1940RAPS.RAC-US.v2022-01-21.q33; 85RAPS.Pass4surecert.RAC-US.v2021-09-28.by.meroy.35q.pdf

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