RAC-GS Dumps By Pros – 1st Attempt Guaranteed Success [Q26-Q42]

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RAC-GS Dumps By Pros – 1st Attempt Guaranteed Success

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To be eligible to take the RAC-GS exam, a candidate must have at least five years of regulatory experience, with at least three of those years in a global regulatory environment. In addition, candidates must have a bachelor’s degree or higher in a related field, or an equivalent combination of education and experience. RAC-GS exam is offered twice a year, and candidates must register in advance and pay a registration fee to take the exam.

NEW QUESTION 26
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from
the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory
authorities?

NEW QUESTION 27
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?

Obtain a copy of the proposed regulation and analyze the impact.

Inform the company’s senior management and arrange an emergency meeting

Consult with the company’s legal department regarding options.

Arrange for additional testing of the product at the testing facility.

NEW QUESTION 28
According to ICH, which of the following components of study information is NOT required in a clinical
study report?

Randomization scheme and codes

Protocol and protocol amendments

List of lECs or lRBs

Detailed CV of all investigators

NEW QUESTION 29
Which term does NOT describe the same concept as the others?

Biosimilars

Follow-on protein products

Monoclonal antibody

Subsequent entry biologics

NEW QUESTION 30
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?

Contact the regulatory authority to argue that its conclusions are wrong.

Contact the regulatory authority to discuss its findings.

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

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

NEW QUESTION 31
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new
drug development. Despite differences in the manufacturing processes of the companies, both APIs meet
the current specifications. Which is the MOST appropriate information to include in the final submission
documents?

The process information and analytical result of Company X API

The process information and analytical result of Company Y API

The process information and the comparative analytical result of APIs from both companies

Information deemed appropriate by the regulatory authority

NEW QUESTION 32
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?

The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change.

Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer.

The manufacturer’s experience level with the type of IVD medical device is limited.

The device incorporates well-established technology that is already present in the market.

NEW QUESTION 33
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?

Production

Analytical

Quality

Regulatory

NEW QUESTION 34
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?

Initiate testing immediately to ensure compliance.

Consult with colleagues about the request.

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

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

NEW QUESTION 35
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The
intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

Perform either an identification study or a non-clinical qualification study.

Perform both identification and non-clinical qualification studies concurrently.

Perform an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study.

Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study.

NEW QUESTION 36
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?

Potential clinical sites for the Phase III clinical trial

Regulatory requirements for labeling and packaging

Capacity of the manufacturing facilities to fully produce the new product

Previous actions taken by regulatory authorities on similar products

NEW QUESTION 37
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?

Systematic procedure to review published scientific journals

Systematic procedure to review experiences with the products in use

Vigilance procedure to ensure the full traceability of the products

Vigilance procedure to notify the regulatory authorities about serious incidents

NEW QUESTION 38
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?

Transfer the notice of the upcoming international monograph change to QA for further processing.

Prepare the international monograph change submission first and then prepare the local change when
required.

Confirm that the international monograph change is not related to local pharmacopeia.

Analyze the impact of the international monograph change on the local pharmacopeia.

NEW QUESTION 39
Which of the following statements regarding the off-label use of drugs is CORRECT?

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

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

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.

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

NEW QUESTION 40
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level,
the medical device continues to have unacceptable risks. However, the development team wants to
continue development. Which is the BEST recommendation to make in this situation?

Add a warning in the IFU.

Discontinue the project.

Perform another risk-benefit analysis.

Redesign the device.

NEW QUESTION 41
According to ICH, how many stability time points are normally required to establish a two-year shelf life for
a product?

NEW QUESTION 42
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

Subject is hospitalized due to complications of the product administration.

Subject is hospitalized for the purpose of product administration.

Subject’s hospitalization is due to an unscheduled hip operation.

Subject’s hospitalization is prolonged during the clinical trial.

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To be eligible to take the RAC-GS certification exam, candidates must have at least three years of experience in regulatory affairs, with at least one year spent working in a global regulatory environment. Candidates must also have a bachelor’s degree or higher in a relevant field, or an equivalent combination of education and experience.

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