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RAC-GS Real Exam Questions

Regulatory Affairs Certification (RAC) Global Scope

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Question 1 Single choice

The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.

Which of the following actions should the regulatory affairs professional take?

  1. A

    Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.

  2. B

    Ask that the regulatory authority provide the actual product subject to the complaint.

  3. C

    Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.

  4. D

    Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.

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Correct answer: A

Question 2 Single choice

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach.
The reviewer is referring to which of the following?

  1. A

    ISO 14971 risk analysis

  2. B

    Failure mode and effect analysis

  3. C

    Fault tree analysis

  4. D

    Hazard and operability study

Show answer and explanation

Correct answer: A

Question 3 Multiple choice

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

  1. A

    Module 1

  2. B

    Module 2

  3. C

    Module 3

  4. D

    Module 4

Show answer and explanation

Correct answers: B, C

Question 4 Single choice

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.

What should the regulatory affairs professional do FIRST to meet the new requirement?

  1. A

    Contact the trade association for advice.

  2. B

    Communicate with the relevant internal departments.

  3. C

    Prepare documents for the files.

  4. D

    Request a permanent waiver from the new regulation.

Show answer and explanation

Correct answer: B

Question 5 Single choice

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

  1. A

    Safety and failure risk

  2. B

    Safety and effectiveness

  3. C

    Quality and failure risk

  4. D

    Quality and effectiveness

Show answer and explanation

Correct answer: B

Question 6 Single choice

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?

  1. A

    100 patients for 12 months

  2. B

    200 patients for nine months

  3. C

    500 patients for three months

  4. D

    3.000 total patient exposures

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Correct answer: A

Question 7 Multiple choice

An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance.

Which of the following actions should the regulatory affairs professional complete FIRST?

  1. A

    Stop product manufacturing.

  2. B

    Establish validation procedures.

  3. C

    Assess the impact of the changes.

  4. D

    Review the stability data for the changes.

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Correct answers: A, C

Question 8 Single choice

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

  1. A

    "Product X is a guaranteed cure for arthritis."

  2. B

    "Product X is effective for the treatment of arthritis."

  3. C

    "Product X is safe for arthritis and without side effects."

  4. D

    "Product X is effective in all patients with arthritis."

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Correct answer: B

Question 9 Multiple choice

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

  1. A

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

  2. B

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

  3. C

    A major safety finding from a newly completed animal carcinogenicity study

  4. D

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

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Correct answers: A, D

Question 10 Single choice

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

  1. A

    25: C and 60% RH

  2. B

    30?C and 35% RH

  3. C

    30c C and 65% RH

  4. D

    30: C and 75% RH

Show answer and explanation

Correct answer: D