최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US

문제1

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. Quality

B. Production

C. Regulatory

D. Analytical

정답: A

문제2

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

A. Develop a generic version of the drug.

B. Develop a better brand-name drug in the same class.

C. Explore litigation strategy for patent infringements on the drug.

D. Conduct a Phase III study for a new unrelated indication of the drug.

정답: A

문제3

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 peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

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 regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.

정답: A

문제4

A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

A. The ISO Secretariat

B. The ISO national member body

C. The ISO technical committee in charge of the area

D. The country's regulatory authority

정답: B

문제5

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

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

D. Contact the regulatory authority to discuss its findings.

정답: D

문제6

Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

A. Intellectual properly

B. Marketing materials

C. Safety issues

D. Clinical trial data

정답: C

문제7

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A. Proposed dose and volume of administration

B. Proposed product route and frequency of administration

C. Immunochemical and functional tests

D. Biological activity with species and/or tissue specificity

정답: D

문제8

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A. Adverse environmental impacts

B. Inadequate training

C. Late and/or incorrect deliverables

D. Causes of non-conformities

정답: D

문제9

A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

A. For a minimum of 10 years after completion of the clinical study

B. For at least two years after the last approval of an application in an ICH region

C. Until the product has been discontinued from marketing in all ICH regions

D. Three years after the last clinical study site was supplied with investigational drugs

정답: B

문제10

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?

A. 500 patients for three months

B. 100 patients for 12 months

C. 3.000 total patient exposures

D. 200 patients for nine months

정답: B

최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US

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