[Q55-Q74] Real RAPS RAC-US Exam Questions [Updated 2024]

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Real RAPS RAC-US Exam Questions [Updated 2024]

RAC-US Exam Dumps Pass with Updated 2024 Regulatory Affairs Certification (RAC) US

To be eligible to take the RAC-US exam, individuals must have at least two years of regulatory affairs experience and a bachelor’s degree in a related field. RAC-US exam is offered twice a year and is available in both online and paper-based formats.

NEW QUESTION 55
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 56
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

25: C and 60% RH

30 C and 35% RH

30c C and 65% RH

30: C and 75% RH

NEW QUESTION 57
What is the LAST stage in the development of a quality risk management process for a medical device?

Risk analysis

Risk reduction

Risk acceptance

Risk evaluation

NEW QUESTION 58
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y’s products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.

Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

NEW QUESTION 59
Which of the following BEST describes the purpose of the ICH?

To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

NEW QUESTION 60
A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

In vitro studies show the product to be superior.

Government survey data indicate the product is superior.

Results of a three-year, post-market patient survey indicate the product is superior.

Results of adequate, well-controlled comparative clinical trial show the product is superior.

NEW QUESTION 61
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

Submit the product for review as a pharmaceutical product in Country Y.

Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

Apply for review of the additional part of the product as a pharmaceutical product in Country

Examine decisions made about similar products in Country Y to propose the classification of the product.

NEW QUESTION 62
Which of the following is NOT required to be included in a marketing application?

Final printed label

Quality, safety, and efficacy Information

Administrative forms

Evidence of fee payment

NEW QUESTION 63
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 64
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 65
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?

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

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

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

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

NEW QUESTION 66
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

Fishbone analysis

Failure modes, effects, and criticality analysis

Fault tree analysis

Quality by design analysis

NEW QUESTION 67
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?

Quality improvement

Quality assurance

Clinical affairs

Regulatory agency

NEW QUESTION 68
In which section of the ICH Common Technical Document will the overview of clinical data appear?

Module 1

Module 2

Module 3

Module 4

NEW QUESTION 69
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

Concept development and validation

Concept development and early technical design

Early technical design and product release

Product release and validation

NEW QUESTION 70
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

Document any failure to follow regulatory compliance processes in employee performance reviews.

Develop documented procedures for regulatory compliance processes and train personnel.

Train all new employees on regulatory compliance processes and assign a mentor to them.

Train employees on all regulatory compliance processes using state-of-the-art systems.

NEW QUESTION 71
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

Resubmit the entire package.

Inform upper management immediately.

Contact the legal department and ask them how to proceed.

Verify the procedure in the regulation for the corrections.

NEW QUESTION 72
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?

The ISO national member body

The ISO technical committee in charge of the area

The ISO Secretariat

The country’s regulatory authority

NEW QUESTION 73
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?

Intellectual properly

Clinical trial data

Safety issues

Marketing materials

NEW QUESTION 74
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

Local reimbursement requirements

Service operation procedures

Training program for sales people

Written procedure for product traceability

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