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Regulatory Affairs Certification (RAC) Global

Scope

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Sample Questions

Question # 1:

Which of the following statements regarding the off-label use of drugs is

CORRECT?

A. Although the regulatory authority reviews and approves drugs for specific

indications, the approval does not limit the use of those drugs in clinical

practice.

B. The regulatory authority does not restrict physician prescribing for off-label

indications or regulate the manufacturer's promotion for such use.

C. Sponsors are allowed to distribute publications about unapproved uses of

approved drugs and devices as long as the marketing application is under

review by the regulatory authority.

D. The peer-reviewed literature can ensure high-quality off-label promotion of

medications, thereby increasing access to much needed drugs and devices.

Answer: A

Question # 2:

A drug product presents degradation during the manufacturing process. In

addition to the amount, what information should be provided FIRST in

order to use API overage?

A. Specification

B. Formulation

C. Property

D. Justification

Answer: D

Question # 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. Discuss with the regulatory apriority and attempt to reach an acceptable

solution.

B. Inform the internal departments to redesign the product to comply with

this requirement.

C. Inform the regulatory authority that such a requirement is not

applicable to the product.

D. Notify senior management that the product cannot be registered.

Answer: A

Question # 4:

Which of the following statements regarding export regulations for an

approved product is CORRECT?

A. The product must not be in accord with the specifications of the foreign

purchaser.

B. The product must not be in conflict with the laws of the country to

which it is intended for export.

C. The product must not be labeled on the outside of the shipping package

that it is intended for export.

D. The product must not be sold or offered for sale in domestic commerce.

Answer: B

Question # 5:

The intermediate manufacturing process was changed during development

of a pharmaceutical. The change may impact the API specification. Which

functional area is responsible for the final approval of the change?

A. Production

B. Analytical

C. Quality

D. Regulatory

Answer: C, D

Question # 6:

Under which of the following circumstances would a regulatory authority

require a more detailed premarket submission, a more rigorous audit,

and/or the provision of more performance evaluation data than would

normally apply to an IVD device of that risk class?

A. The device is an updated version of a compliant device from the same

manufacturer and contains no substantive change.

B. Internationally recognized standards are available to cover the main

aspects of the device and have been used by the manufacturer.

C. The manufacturer's experience level with the type of IVD medical device

is limited.

D. The device incorporates well-established technology that is already

present in the market.

Answer: C

Question # 7:

According to WHO, what are the temperature and humidity conditions for a

Zone IVb long term stability study?

A. 25: C and 60% RH

B. 30° C and 35% RH

C. 30c C and 65% RH

D. 30: C and 75% RH

Answer: D

Question # 8:

During routine surveillance, a regulatory authority sent a company the

following communication: "Hepatotoxicity and suicidal behavior were

identified as potential safety issues for the company's product. The

regulatory authority is evaluating these issues to determine the need for

any regulatory action." Which action would be the most appropriate FIRST

step for the company to take?

A. Contact the regulatory authority to argue that its conclusions are wrong.

B. Contact the regulatory authority to discuss its findings.

C. Repeat the Hepatotoxicity tests and send the results to the regulatory

authority.

D. Wait for the regulatory authority's final publication on its findings.

Answer: B

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