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最新的 RAC Regulatory Affairs Certification RAC-US 免費考試真題:

1. During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A) Contact the marketing department to recall the product.
B) Request that doctors stop using the product for the off-label indication.
C) Allow doctors to use the product for the off-label indication.
D) Communicate with the sales department to stop using the promotional materials.

2. 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?

A) Deny the auditor access to the room and records due to confidentiality concerns.
B) Allow the auditor accompanied access to the room to retrieve the records.
C) Deny the auditor access to the room and retrieve only the requested records.
D) Allow the auditor access to the room and records due to the current audit.

3. In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A) Inform the regulatory authority that such a requirement is not applicable to the product.
B) Inform the internal departments to redesign the product to comply with this requirement.
C) Discuss with the regulatory apriority and attempt to reach an acceptable solution.
D) Notify senior management that the product cannot be registered.

4. In which section of the ICH Common Technical Document will the overview of clinical data appear?

A) Module 3
B) Module 2
C) Module 4
D) Module 1

5. According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

A) 30c C and 65% RH
B) 30 C and 35% RH
C) 30: C and 75% RH
D) 25: C and 60% RH

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