QUESTION: 45

During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

Allow the auditor access to the room and records due to the current audit.
Allow the auditor accompanied access to the room to retrieve the records.
Deny the auditor access to the room and retrieve only the requested records.
Deny the auditor access to the room and records due to confidentiality concerns.

Answer(s): B

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QUESTION: 46

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?

Adverse event reports
Clinical experience
Clinical investigations
Literature search

Answer(s): C

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QUESTION: 47

As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

Inform the regulatory authorities.
Delay the start of product production.
Correct the label text.
Abort the product launch.

Answer(s): A

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QUESTION: 48

A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

Use the Madrid system.
Use the community patent system.
File patents of interest in target countries.
File design patents in target countries.

Answer(s): C

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QUESTION: 45

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QUESTION: 48