[Nov 24, 2021] New RAC-GS Exam Dumps with High Passing Rate
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NEW QUESTION 16
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a
regulatory affairs professional to become involved?
- A. Concept development and early technical design
- B. Early technical design and product release
- C. Product release and validation
- D. Concept development and validation
Answer: A
NEW QUESTION 17
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. Inform the authority that the time is not suitable and request a new time
- B. Negotiate with colleagues and the authority to find a better time.
- C. Arrange for an inspection without all intended personnel.
- D. Insist that key personnel be available for the inspection.
Answer: B
NEW QUESTION 18
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 19
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 20
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 21
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 25: C and 60% RH
- B. 30c C and 65% RH
- C. 30 C and 35% RH
- D. 30: C and 75% RH
Answer: D
NEW QUESTION 22
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 23
A company is developing a device-drug combination product. Which of the following should be evaluated
FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 24
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. Label the product for use in appropriate populations.
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Educate patients and healthcare providers on how to use the product
Answer: B
NEW QUESTION 25
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. Labeling
- B. Safety-related reporting
- C. Risk management process
- D. Regulatory application summary
Answer: A
NEW QUESTION 26
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. Initiate testing immediately to ensure compliance.
- B. Send a letter back to the regulatory authority indicating why the regulation does not apply to the
product. - C. Contact the regulatory authority that issued this request and discuss the requirement.
- D. Consult with colleagues about the request.
Answer: C
NEW QUESTION 27
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Vigilance procedure to notify the regulatory authorities about serious incidents
- B. Vigilance procedure to ensure the full traceability of the products
- C. Systematic procedure to review experiences with the products in use
- D. Systematic procedure to review published scientific journals
Answer: B
NEW QUESTION 28
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 29
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?
- A. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
requirement and assign responsibilities. - B. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones. - C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority. - D. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority.
Answer: C
NEW QUESTION 30
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 31
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. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 32
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?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION 33
As a member of the product launch review committee, a regulatory affairs professional discovers a major
issue with the labeling of a product prior to production. In addition to informing the committee, which is the
BEST approach to address the issue?
- A. Inform the regulatory authorities.
- B. Delay the start of product production.
- C. Correct the label text.
- D. Abort the product launch.
Answer: A
NEW QUESTION 34
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 actual product subject to the complaint.
- B. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release. - C. Ask that the regulatory authority provide the batch number printed on the packaging of the affected
product. - D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product.
Answer: C
NEW QUESTION 35
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. No action is needed in this situation.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
Answer: C
NEW QUESTION 36
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
Answer: B
NEW QUESTION 37
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. The time frame in which the patent will expire
- B. International import and export regulations
- C. The stability of the drug in all zone conditions
- D. Doha Declaration in the TRIPS Agreement
Answer: C
NEW QUESTION 38
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?
- A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study. - B. Perform an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study. - C. Perform both identification and non-clinical qualification studies concurrently.
- D. Perform either an identification study or a non-clinical qualification study.
Answer: B
NEW QUESTION 39
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Quality by design analysis
- B. Fishbone analysis
- C. Failure modes, effects, and criticality analysis
- D. Fault tree analysis
Answer: C
NEW QUESTION 40
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 the industry representative
- C. After the enactment of the regulation, through a product-specific meeting
- D. Before the enactment of the regulation, through formal comments gathering process
Answer: D
NEW QUESTION 41
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