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Pass the RAPS RAC Regulatory Affairs Certification RAC-GS Questions and answers with ExamsMirror

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Questions # 11:

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?

Options:

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.

Questions # 12:

Which of the following BEST describes the purpose of the ICH?

Options:

A.

To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

B.

To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

C.

To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

D.

To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

Questions # 13:

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

Options:

A.

Resubmit the entire package.

B.

Inform upper management immediately.

C.

Contact the legal department and ask them how to proceed.

D.

Verify the procedure in the regulation for the corrections.

Questions # 14:

The safety database for an anti-hypertensive drug consists of the following:

• 461 patients exposed for three months

• 343 patients exposed for six months

• 112 patients exposed for nine months

• 74 patients exposed for 12 months

Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

Options:

A.

100 patients for 12 months

B.

200 patients for nine months

C.

500 patients for three months

D.

3.000 total patient exposures

Questions # 15:

A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

Options:

A.

Obtain a copy of the proposed regulation and analyze the impact.

B.

Inform the company's senior management and arrange an emergency meeting

C.

Consult with the company's legal department regarding options.

D.

Arrange for additional testing of the product at the testing facility.

Questions # 16:

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

Options:

A.

Final printed label

B.

Quality, safety, and efficacy Information

C.

Administrative forms

D.

Evidence of fee payment

Questions # 17:

Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

Options:

A.

Before the enactment of the regulation, through the industry representative

B.

Before the enactment of the regulation, through formal comments gathering process

C.

After the enactment of the regulation, through the industry representative

D.

After the enactment of the regulation, through a product-specific meeting

Questions # 18:

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

Options:

A.

Transfer the notice of the upcoming international monograph change to QA for further processing.

B.

Prepare the international monograph change submission first and then prepare the local change when required.

C.

Confirm that the international monograph change is not related to local pharmacopeia.

D.

Analyze the impact of the international monograph change on the local pharmacopeia.

Questions # 19:

Which of the following situations does NOT require rapid communication to regulatory authorities?

Options:

A.

A clinically important increase in the rate of occurrence of an "expected." but serious ADR

B.

A lack of efficacy with a medicinal product used in treating a life-threatening disease

C.

A major safety finding from a newly completed animal carcinogenicity study

D.

A statistically significant increase in the number of deaths in an animal dose finding study

Questions # 20:

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Options:

A.

Deficiency of a device found by the user prior to patient use

B.

Adverse event caused by patient conditions

C.

Malfunction occurring before the end of service life of the medical device

D.

Malfunction protection operated correctly

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