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

出題：1

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

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

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

C. "Product X is a guaranteed cure for arthritis."

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

正解：D 解答を投票する

出題：2

A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

A. Recommend an immediate product recall.

B. Compare the approved text with the product label

C. Notify the regulatory authority.

D. Inform the production team.

正解：B 解答を投票する

出題：3

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

A. Plan regulatory approval update meetings with senior management and stakeholders.

B. Identify countries where special requirements exist during the product development phase.

C. Utilize the STED template to complete global requirements.

D. Initiate a global submission process after all submission data are finalized.

正解：B 解答を投票する

出題：4

A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

A. Consult with colleagues about the request.

B. Contact the regulatory authority that issued this request and discuss the requirement.

C. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

D. Initiate testing immediately to ensure compliance.

正解：B 解答を投票する

出題：5

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?

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

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

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

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

正解：B 解答を投票する

出題：6

A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

B. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.

C. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

D. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

正解：B,C 解答を投票する

出題：7

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：8

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?

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

B. After the enactment of the regulation, through the industry representative

C. Before the enactment of the regulation, through the industry representative

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

正解：D 解答を投票する

出題：9

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Regulatory agency

B. Quality assurance

C. Quality improvement

D. Clinical affairs

正解：B 解答を投票する

出題：10

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. Notify senior management that the product cannot be registered.

C. Inform the internal departments to redesign the product to comply with this requirement.

D. Inform the regulatory authority that such a requirement is not applicable to the product.

正解：A 解答を投票する

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