Free RAPS RAC-GS Exam Dumps Questions & Answers

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

• A.Training program for sales people
• B.Service operation procedures
• C.Local reimbursement requirements
• D.Written procedure for product traceability

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.Ask the trade association representative to provide an overview of the new product area to the marketing team.
• C.Summarize regulatory documents and history and provide the information to the management team.
• D.Obtain regulatory documents and history and provide the information to R&D.

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

• A.Advise the senior management to send a "Dear Dr." letter.
• B.Discuss with regulatory authorities to investigate how to have the off-label indication approved.
• C.File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
• D.No action is required since it is an off-label use.

Which of the following is NOT required to be included in a marketing application?

• A.Administrative forms
• B.Evidence of fee payment
• C.Quality, safety, and efficacy Information
• D.Final printed label

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