RAC-GS Free Exam Questions & Answers PDF Updated on Oct-2021
Latest RAC-GS Exam Dumps Recently Updated 100 Questions
NEW QUESTION 60
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Prepare documents for the files.
- B. Communicate with the relevant internal departments.
- C. Request a permanent waiver from the new regulation.
- D. Contact the trade association for advice.
Answer: B
NEW QUESTION 61
A global company has obtained a patent in a specific country for a newly marketed product. What would
be the BEST advice In order to protect the patent in other countries?
- A. File patents of interest in target countries.
- B. Use the community patent system.
- C. File design patents in target countries.
- D. Use the Madrid system.
Answer: A
NEW QUESTION 62
One month prior to the anticipated approval date for your product, the marketing application that you
submitted to a major regulatory authority has become the subject of an advisory committee meeting of
experts convened by the regulatory authority. The advisory committee members unanimously vote not to
approve your product because of a safety concern. Two days after the advisory committee meeting, the
regulatory authority requests additional information to support the safety of your product. Assuming you
have no additional data to provide, which of the following would be your MOST appropriate response to
the regulatory authority's request?
- A. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval." - B. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference." - C. "We disagree with the advisory committee's decision because the committee neglected the thorough
safety analysis that we provided." - D. "We have no additional information to provide at this time, but we can perform an additional analysis for
a specific safety concern, if necessary."
Answer: D
NEW QUESTION 63
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Request an inspection from a regulatory authority.
- B. Request documentation from the sub-contractor.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
Answer: D
NEW QUESTION 64
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 65
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 66
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will satisfy hunger."
- C. "It will whiten teeth."
- D. "It will prevent colds."
Answer: D
NEW QUESTION 67
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?
- A. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 68
Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?
- A. "Product X is a guaranteed cure for arthritis."
- B. "Product X is effective for the treatment of arthritis."
- C. "Product X is safe for arthritis and without side effects."
- D. "Product X is effective in all patients with arthritis."
Answer: B
NEW QUESTION 69
The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to
serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?
- A. Draft a formal letter to customers in Country Y about this recall.
- B. Review alt distribution records and complaints reported in Country Y.
- C. Prepare the legal team in Country Y for possible litigations.
- D. Initiate a mandatory recall of the product in Country Y.
Answer: B
NEW QUESTION 70
The requirements for document control are located in which of the following documents?
- A. ISO 13485
- B. WHO guidelines
- C. ICH guidelines
- D. IEC 60601
Answer: A
NEW QUESTION 71
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Request a meeting with the regulatory authority to discuss the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 72
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: A
NEW QUESTION 73
A company establishes a new medical device indication for its consumer disposable products. The
regulatory affairs professional is asked to give a 30-minute training session on these products to sales
representatives. Which of the following subjects is the MOST important to discuss?
- A. Regulatory application summary
- B. Safety-related reporting
- C. Risk management process
- D. Labeling
Answer: D
NEW QUESTION 74
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. Proposed product route and frequency of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
Answer: C
NEW QUESTION 75
A company's product was approved by a regulatory authority with the condition that further studies must
be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the
LEAST effective way to achieve this goal?
- A. Educate patients and healthcare providers on how to use the product
- B. Label the product for use in appropriate populations.
- C. Delay product launch until required studies are completed.
- D. Promote off-label use to a carefully selected patient population.
Answer: D
NEW QUESTION 76
Which of the following BEST describes the purpose of the ICH?
- A. To lobby for improved industry standards for the development of new safe, effective, and high-quality
medicines for the ICH regions - B. To protect and promote public health through the evaluation and supervision of safe, effective, and
high-quality medicines for the ICH regions - C. To provide scientific evaluation of applications for international marketing authorization for safe,
effective, and high-quality medicines for the ICH regions - D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH
regions
Answer: D
NEW QUESTION 77
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 the industry representative
- B. Before the enactment of the regulation, through formal comments gathering process
- C. Before the enactment of the regulation, through the industry representative
- D. After the enactment of the regulation, through a product-specific meeting
Answer: B
NEW QUESTION 78
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on
the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 79
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 4
- B. Module 3
- C. Module 2
- D. Module 1
Answer: C
NEW QUESTION 80
During the review of a design dossier, the reviewer asks why the company has only carried out a
top-down risk approach. The reviewer is referring to which of the following?
- A. Hazard and operability study
- B. ISO 14971 risk analysis
- C. Failure mode and effect analysis
- D. Fault tree analysis
Answer: B
NEW QUESTION 81
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?
- A. Until the product has been discontinued from marketing in all ICH regions
- B. For at least two years after the last approval of an application in an ICH region
- C. For a minimum of 10 years after completion of the clinical study
- D. Three years after the last clinical study site was supplied with investigational drugs
Answer: B
NEW QUESTION 82
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Early collaboration
- B. Documented agreement
- C. Frequent communication
- D. Follow-up meeting after submission
Answer: C
NEW QUESTION 83
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Train employees on all regulatory compliance processes using state-of-the-art systems.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
Answer: C
NEW QUESTION 84
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
- A. Placebo-controlled
- B. Dose-ranging
- C. Cross-over
- D. Active-controlled
Answer: C
NEW QUESTION 85
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