RAC-US試験無料問題集（100題）「RAPS Regulatory Affairs Certification (RAC) US 認定」

出題：1

A process is ultimately validated to ensure which of the following?

A. The process consistently meets the desired Quantity standards

B. The process meets the quality system requirements.

C. The process consistently produces the desired results.

D. The process meets the regulatory requirements.

正解：C 解答を投票する

出題：2

The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

A. Initiate a mandatory recall of the product in Country Y.

B. Draft a formal letter to customers in Country Y about this recall.

C. Review alt distribution records and complaints reported in Country Y.

D. Prepare the legal team in Country Y for possible litigations.

正解：C 解答を投票する

出題：3

In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

A. Capacity of the manufacturing facilities to fully produce the new product

B. Potential clinical sites for the Phase III clinical trial

C. Previous actions taken by regulatory authorities on similar products

D. Regulatory requirements for labeling and packaging

正解：C 解答を投票する

出題：4

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

A. 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.

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

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

D. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.

正解：D 解答を投票する

出題：5

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

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

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

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

正解：D 解答を投票する

出題：6

A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

A. Insist that key personnel be available for the inspection.

B. Negotiate with colleagues and the authority to find a better time.

C. Arrange for an inspection without all intended personnel.

D. Inform the authority that the time is not suitable and request a new time

正解：B 解答を投票する

出題：7

According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

A. 9

B. 5

C. 7

D. 3

正解：C 解答を投票する

出題：8

Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

A. Deleting an ingredient of the drug product

B. Deleting a drug substance

C. Strengthening a precaution to the product labeling

D. Introducing a new analytical method

正解：C 解答を投票する

出題：9

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

A. Promote off-label use to a carefully selected patient population.

B. Delay product launch until required studies are completed.

C. Educate patients and healthcare providers on how to use the product

D. Label the product for use in appropriate populations.

正解：A 解答を投票する

出題：10

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?

A. Assess the impact of the changes.

B. Establish validation procedures.

C. Review the stability data for the changes.

D. Stop product manufacturing.

正解：D 解答を投票する

RAC-US試験無料問題集「RAPS Regulatory Affairs Certification (RAC) US 認定」