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Download Regulatory Affairs Certification (RAC) US Exam Dumps

NEW QUESTION 30
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

  • A. Train employees on all regulatory compliance processes using state-of-the-art systems.
  • B. Develop documented procedures for regulatory compliance processes and train personnel.
  • C. Document any failure to follow regulatory compliance processes in employee performance reviews.
  • D. Train all new employees on regulatory compliance processes and assign a mentor to them.

Answer: B

 

NEW QUESTION 31
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  • A. Doha Declaration in the TRIPS Agreement
  • B. International import and export regulations
  • C. The time frame in which the patent will expire
  • D. The stability of the drug in all zone conditions

Answer: D

 

NEW QUESTION 32
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 pooling
  • C. Plasma fractionation
  • D. Individual plasma donation

Answer: A

 

NEW QUESTION 33
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 competitor research and provide the information to the management team.
  • D. Obtain regulatory documents and history and provide the information to R&D.

Answer: B

 

NEW QUESTION 34
……

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