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NEW QUESTION 48
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 49
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Systematic procedure to review published scientific journals
- B. Systematic procedure to review experiences with the products in use
- C. Vigilance procedure to ensure the full traceability of the products
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
Answer: C
NEW QUESTION 50
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 51
A process is ultimately validated to ensure which of the following?
- A. The process consistently produces the desired results.
- B. The process consistently meets the desired Quantity standards
- C. The process meets the regulatory requirements.
- D. The process meets the quality system requirements.
Answer: A
NEW QUESTION 52
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 53
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 54
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. Stop product manufacturing.
- B. Review the stability data for the changes.
- C. Establish validation procedures.
- D. Assess the impact of the changes.
Answer: A
NEW QUESTION 55
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 56
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 57
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30: C and 75% RH
- B. 30c C and 65% RH
- C. 25: C and 60% RH
- D. 30 C and 35% RH
Answer: A
NEW QUESTION 58
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Deny the auditor access to the room and retrieve only the requested records.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Allow the auditor access to the room and records due to the current audit.
Answer: A
NEW QUESTION 59
Which of the following is the PRIMARY purpose of an audit report?
- A. To train sales representatives
- B. To define how to prepare new product submissions
- C. To carry out a complete review of product applications
- D. To document compliance history
Answer: D
NEW QUESTION 60
A company is preparing the submission package for a drug to be registered in international markets.
When preparing the legal documentation, which document MUST comply with the WHO
recommendations?
- A. Certificate of Pharmaceutical Product
- B. Certificate of GMP
- C. Certificate of Analysis for the finished product
- D. Certificate of Free Sale
Answer: A
NEW QUESTION 61
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. Malfunction protection operated correctly
- C. Deficiency of a device found by the user prior to patient use
- D. Malfunction occurring before the end of service life of the medical device
Answer: A
NEW QUESTION 62
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 63
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. Early technical design and product release
- B. Concept development and early technical design
- C. Concept development and validation
- D. Product release and validation
Answer: B
NEW QUESTION 64
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 65
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