[Jan 25, 2022] Powerful RAC-GS PDF Dumps for RAC-GS Questions
Authentic RAC-GS Dumps - Free PDF Questions to Pass
NEW QUESTION 18
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?
- A. Develop a generic version of the drug.
- B. Develop a better brand-name drug in the same class.
- C. Conduct a Phase III study for a new unrelated indication of the drug.
- D. Explore litigation strategy for patent infringements on the drug.
Answer: A
NEW QUESTION 19
What are the MOST important elements that global regulatory agencies want to know before approving a
new product for sale in their countries?
- A. Safety and failure risk
- B. Quality and failure risk
- C. Quality and effectiveness
- D. Safety and effectiveness
Answer: D
NEW QUESTION 20
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new
drug development. Despite differences in the manufacturing processes of the companies, both APIs meet
the current specifications. Which is the MOST appropriate information to include in the final submission
documents?
- A. The process information and analytical result of Company X API
- B. Information deemed appropriate by the regulatory authority
- C. The process information and analytical result of Company Y API
- D. The process information and the comparative analytical result of APIs from both companies
Answer: D
NEW QUESTION 21
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Local reimbursement requirements
- B. Training program for sales people
- C. Written procedure for product traceability
- D. Service operation procedures .
Answer: B
NEW QUESTION 22
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Develop documented procedures for regulatory compliance processes and train personnel.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
Answer: A
NEW QUESTION 23
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. In vitro studies show the product to be superior.
- B. Results of a three-year, post-market patient survey indicate the product is superior.
- C. Government survey data indicate the product is superior.
- D. Results of adequate, well-controlled comparative clinical trial show the product is superior.
Answer: D
NEW QUESTION 24
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Inventory control
- B. Safety assurance
- C. Efficacy confirmation
- D. Quality verification
Answer: D
NEW QUESTION 25
According to ICH, which of the following components of study information is NOT required in a clinical
study report?
- A. List of lECs or lRBs
- B. Randomization scheme and codes
- C. Detailed CV of all investigators
- D. Protocol and protocol amendments
Answer: C
NEW QUESTION 26
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Contact the marketing department to recall the product.
- B. Request that doctors stop using the product for the off-label indication.
- C. Communicate with the sales department to stop using the promotional materials.
- D. Allow doctors to use the product for the off-label indication.
Answer: C
NEW QUESTION 27
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?
- A. Production
- B. Analytical
- C. Regulatory
- D. Quality
Answer: D
NEW QUESTION 28
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. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - B. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - C. The device incorporates well-established technology that is already present in the market.
- D. The manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 29
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 country's regulatory authority
- B. The ISO Secretariat
- C. The ISO national member body
- D. The ISO technical committee in charge of the area
Answer: C
NEW QUESTION 30
Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?
- A. "Product X is effective in all patients with arthritis."
- B. "Product X is safe for arthritis and without side effects."
- C. "Product X is effective for the treatment of arthritis."
- D. "Product X is a guaranteed cure for arthritis."
Answer: C
NEW QUESTION 31
In preparation for the development of a new line of products, a regulatory affairs professional is asked to
prepare a short presentation for senior management. Which of the following topics is MOST important to
cover?
- A. Capacity of the manufacturing facilities to fully produce the new product
- B. Potential clinical sites for the Phase III clinical trial
- C. Previous actions taken by regulatory authorities on similar products
- D. Regulatory requirements for labeling and packaging
Answer: C
NEW QUESTION 32
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. Fault tree analysis
- B. ISO 14971 risk analysis
- C. Hazard and operability study
- D. Failure mode and effect analysis
Answer: B
NEW QUESTION 33
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Obtain competitor research and provide the information to the management team.
- B. Summarize regulatory documents and history and provide the information to the management team.
- C. Obtain regulatory documents and history and provide the information to R&D.
- D. Ask the trade association representative to provide an overview of the new product area to the
marketing team.
Answer: B
NEW QUESTION 34
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical
device?
- A. Risk management
- B. Risk estimation
- C. Risk control
- D. Risk analysis
Answer: D
NEW QUESTION 35
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ICH guidelines
- C. IEC 60601
- D. ISO 13485
Answer: D
NEW QUESTION 36
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 statistically significant increase in the number of deaths in an animal dose finding study
- C. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- D. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
Answer: D
NEW QUESTION 37
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. Quality improvement
- B. Clinical affairs
- C. Regulatory agency
- D. Quality assurance
Answer: D
NEW QUESTION 38
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. 25: C and 60% RH
- C. 30 C and 35% RH
- D. 30c C and 65% RH
Answer: A
NEW QUESTION 39
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 access to the room and records due to the current audit.
- B. Deny the auditor access to the room and records due to confidentiality concerns.
- C. Allow the auditor accompanied access to the room to retrieve the records.
- D. Deny the auditor access to the room and retrieve only the requested records.
Answer: C
NEW QUESTION 40
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk reduction
- B. Risk evaluation
- C. Risk acceptance
- D. Risk analysis
Answer: C
NEW QUESTION 41
Company X encounters challenges in the global life cycle management of its medical devices. Which of
the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Plan regulatory approval update meetings with senior management and stakeholders.
- C. Initiate a global submission process after all submission data are finalized.
- D. Utilize the STED template to complete global requirements.
Answer: A
NEW QUESTION 42
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