[2021] Use Valid RAC-GS Exam - Actual Exam Question & Answer
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NEW QUESTION 56
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?
- A. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - B. The device incorporates well-established technology that is already present in the market.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - D. The manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 57
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. All senior management from the main office
- B. As many as required by international standards
- C. The minimum number of attendees necessary to address the issues
- D. As many as government attendees
Answer: C
NEW QUESTION 58
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Pre-clinical studies
Answer: A
NEW QUESTION 59
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Manufacturer
- B. Consumer
- C. Regulatory authority
- D. Distributor
Answer: A
NEW QUESTION 60
At a recent scientific meeting, Company Y had two booths:
. At one booth, Company Y provided brochures on a completed Phase II study.
. In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed
products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting
that Company Y stop this practice in the future and demanding a formal response to the letter. How
should the regulatory affairs professional at Company Y BEST respond?
- A. Acknowledge receipt of the letter in a written response but do nothing further.
- B. Inform the local regulatory authority of the letter and discuss how to respond.
- C. Inform Company X that it has no right to send such a letter and do nothing further.
- D. Inform the legal department of the letter and discuss how to respond.
Answer: D
NEW QUESTION 61
Which term does NOT describe the same concept as the others?
- A. Follow-on protein products
- B. Biosimilars
- C. Monoclonal antibody
- D. Subsequent entry biologics
Answer: C
NEW QUESTION 62
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?
- A. Revision history
- B. Relevance to regulations
- C. Scope and level of detail
- D. Expiration date
Answer: B
NEW QUESTION 63
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Physical processing and packaging
- B. Production of Intermediate(s)
- C. Isolation and purification
- D. Introduction of the API starting material
Answer: A
NEW QUESTION 64
A company is currently marketing an implantable orthopedic medical device. The R&D department is
planning to change the material used for the implant. The R&D department states that the change does
not impact the safety and effectiveness of the product. What action should the regulatory affairs
professional take FIRST?
- A. Prepare regulatory submissions that detail the medical device's change in materials.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. No action is needed in this situation.
- D. Review the content of change and supporting data for the equivalency with the current material.
Answer: D
NEW QUESTION 65
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. Notify the global regulatory authorities.
- C. Assess the potential safety risk.
- D. Send a "Dear Dr." letter to customers.
Answer: B
NEW QUESTION 66
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. Contact the regulatory authority that issued this request and discuss the requirement.
- B. Consult with colleagues about the request.
- C. Initiate testing immediately to ensure compliance.
- D. Send a letter back to the regulatory authority indicating why the regulation does not apply to the
product.
Answer: A
NEW QUESTION 67
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical
device?
- A. Risk management
- B. Risk control
- C. Risk estimation
- D. Risk analysis
Answer: D
NEW QUESTION 68
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Export license
- B. Import license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 69
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?
- A. Wait for the regulatory authority's final publication on its findings.
- B. Contact the regulatory authority to discuss its findings.
- C. Contact the regulatory authority to argue that its conclusions are wrong.
- D. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
Answer: B
NEW QUESTION 70
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 batch number printed on the packaging of the affected
product. - B. Ask that the regulatory authority provide the actual product subject to the complaint.
- C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product. - D. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release.
Answer: A
NEW QUESTION 71
According to ICH, how many stability time points are normally required to establish a two-year shelf life for
a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: B
NEW QUESTION 72
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. Although the regulatory authority reviews and approves drugs for specific indications, the approval
does not limit the use of those drugs in clinical practice. - C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby
increasing access to much needed drugs and devices. - D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the
manufacturer's promotion for such use.
Answer: B
NEW QUESTION 73
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized due to complications of the product administration.
- B. Subject is hospitalized for the purpose of product administration.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject's hospitalization is prolonged during the clinical trial.
Answer: B
NEW QUESTION 74
In order to develop a global drug product, what is the MOST important environmental characteristic to
consider in the country of intended use?
- A. Product registration
- B. Product stability
- C. Product formulation
- D. Product requirements
Answer: B
NEW QUESTION 75
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. Inform the authority that the time is not suitable and request a new time
- C. Arrange for an inspection without all intended personnel.
- D. Negotiate with colleagues and the authority to find a better time.
Answer: D
NEW QUESTION 76
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. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: A
NEW QUESTION 77
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