[Nov 14, 2021] RAC-GS PDF Recently Updated Questions Dumps to Improve Exam Score
RAC-GS Dumps Full Questions with Free PDF Questions to Pass
NEW QUESTION 23
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 2
- B. Module 1
- C. Module 4
- D. Module 3
Answer: A
NEW QUESTION 24
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Summarize regulatory documents and history and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - C. Obtain competitor research and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: A
NEW QUESTION 25
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a
reimbursement agency?
- A. "Is the product an established gold standard?"
- B. "Is the product profitable for the manufacturer?"
- C. "Is the product better than currently available alternatives?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: C
NEW QUESTION 26
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?
- A. Clinical affairs
- B. Regulatory agency
- C. Quality assurance
- D. Quality improvement
Answer: C
NEW QUESTION 27
You discover that your company's top selling product in the last two years has been used off-label. The
off-label use is estimated to be about 70%, and it has been consistent since the product was first released
to the market. Which of the following is MOST appropriate?
- A. No action is required since it is an off-label use.
- B. File a report to regulatory authorities and advise the marketing department to prevent future off-label
use. - C. Advise the senior management to send a "Dear Dr." letter.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D
NEW QUESTION 28
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?
- A. Assess the impact of the changes.
- B. Stop product manufacturing.
- C. Establish validation procedures.
- D. Review the stability data for the changes.
Answer: B
NEW QUESTION 29
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?
- A. Discontinue the project.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
Answer: B
NEW QUESTION 30
Which of the following claims would classify an apple as a drug?
- A. "It will prevent colds."
- B. "It will satisfy hunger."
- C. "It will make you look younger."
- D. "It will whiten teeth."
Answer: A
NEW QUESTION 31
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk reduction
- C. Risk evaluation
- D. Risk analysis
Answer: A
NEW QUESTION 32
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?
- A. Intellectual properly
- B. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 33
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage
should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Plasma fractionation
- C. Individual plasma donation
- D. Product distribution
Answer: D
NEW QUESTION 34
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. For at least two years after the last approval of an application in an ICH region
- B. Three years after the last clinical study site was supplied with investigational drugs
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For a minimum of 10 years after completion of the clinical study
Answer: A
NEW QUESTION 35
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. Compare the approved text with the product label
- B. Inform the production team.
- C. Notify the regulatory authority.
- D. Recommend an immediate product recall.
Answer: A
NEW QUESTION 36
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be in conflict with the laws of the country to which it is intended for export.
- C. The product must not be labeled on the outside of the shipping package that it is intended for export.
- D. The product must not be in accord with the specifications of the foreign purchaser.
Answer: B
NEW QUESTION 37
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Malfunction protection operated correctly
Answer: A
NEW QUESTION 38
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?
- A. The ISO national member body
- B. The ISO technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 39
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 stability
- B. Product requirements
- C. Product formulation
- D. Product registration
Answer: A
NEW QUESTION 40
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A major safety finding from a newly completed animal carcinogenicity study
- B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- C. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
- D. A statistically significant increase in the number of deaths in an animal dose finding study
Answer: C
NEW QUESTION 41
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