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

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Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a
reimbursement agency?

• A."Is the product profitable for the manufacturer?"
• B."Has the product been approved for mor&4nan 10 years?"
• C."Is the product an established gold standard?"
• D."Is the product better than currently available alternatives?"

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A company is considering the development of a medical device similar to those already available. Which
of the following should be evaluated FIRST when developing a clinical evaluation document?

• A.Clinical experience
• B.Adverse event reports
• C.Clinical investigations
• D.Literature search

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During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?

• A.The minimum number of attendees necessary to address the issues
• B.All senior management from the main office
• C.As many as required by international standards
• D.As many as government attendees

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At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the
manufacturing process. Which of the following stakeholders should be notified FIRST?

• A.Clinical affairs
• B.Quality improvement
• C.Regulatory agency
• D.Quality assurance

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