RAC-GS Online Practice Questions and Answers

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. Utilize the STED template to complete global requirements.

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

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

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

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. 100 patients for 12 months

B. 200 patients for nine months

C. 500 patients for three months

D. 3.000 total patient exposures

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.

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

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

During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.

Which of the following is the most appropriate action to take FIRST?

A. Withdraw the affected product from the markets.

B. Send a "Dear Dr." letter to customers.

C. Notify the global regulatory authorities.

D. Assess the potential safety risk.

Which of the following is the PRIMARY purpose of an audit report?

A. To carry out a complete review of product applications

B. To define how to prepare new product submissions

C. Todocument compliance history

D. To train sales representatives

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

A. 3

B. 5

C. 7

D. 9

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?

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.

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. Biological activity with species and/or tissue specificity

C. Immunochemical and functional tests

D. Proposed product route and frequency of administration

The requirements for document control are located in which of the following documents?

A. ICH guidelines

B. IEC 60601

C. ISO 13485

D. WHO guidelines