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RAC Regulatory Affairs Certification Dumps RAC-GS Exam for Full Questions - Exam Study Guide
NEW QUESTION 37
Which of the following BEST describes the purpose of the ICH?
- A. To provide scientific evaluation of applications for international marketing authorization for safe,
effective, and high-quality medicines for the ICH regions - B. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH
regions - C. To lobby for improved industry standards for the development of new safe, effective, and high-quality
medicines for the ICH regions - D. To protect and promote public health through the evaluation and supervision of safe, effective, and
high-quality medicines for the ICH regions
Answer: B
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 Secretariat
- C. The country's regulatory authority
- D. The ISO technical committee in charge of the area
Answer: A
NEW QUESTION 39
Which term does NOT describe the same concept as the others?
- A. Biosimilars
- B. Monoclonal antibody
- C. Subsequent entry biologics
- D. Follow-on protein products
Answer: B
NEW QUESTION 40
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. File a report to regulatory authorities and advise the marketing department to prevent future off-label
use. - B. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
- C. Advise the senior management to send a "Dear Dr." letter.
- D. No action is required since it is an off-label use.
Answer: B
NEW QUESTION 41
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. Prepare regulatory submissions that detail the medical device's change in materials.
- B. No action is needed in this situation.
- C. Write a memo to file since the change does not impact product safety and effectiveness.
- D. Review the content of change and supporting data for the equivalency with the current material.
Answer: D
NEW QUESTION 42
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class D
- B. Class A
- C. Class B
- D. Class C
Answer: D
NEW QUESTION 43
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Deficiency of a device found by the user prior to patient use
- B. Malfunction occurring before the end of service life of the medical device
- C. Malfunction protection operated correctly
- D. Adverse event caused by patient conditions
Answer: D
NEW QUESTION 44
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. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 45
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. Regulatory
- B. Quality
- C. Analytical
- D. Production
Answer: B
NEW QUESTION 46
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Efficacy confirmation
- B. Inventory control
- C. Safety assurance
- D. Quality verification
Answer: D
NEW QUESTION 47
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. Biological activity with species and/or tissue specificity
- C. Proposed product route and frequency of administration
- D. Immunochemical and functional tests
Answer: B
NEW QUESTION 48
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?
- A. Revision history
- B. Scope and level of detail
- C. Relevance to regulations
- D. Expiration date
Answer: C
NEW QUESTION 49
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. Communicate with the sales department to stop using the promotional materials.
- B. Allow doctors to use the product for the off-label indication.
- C. Request that doctors stop using the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: A
NEW QUESTION 50
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product
does not meet one of the specific technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
- A. Notify senior management that the product cannot be registered.
- B. Inform the regulatory authority that such a requirement is not applicable to the product.
- C. Inform the internal departments to redesign the product to comply with this requirement.
- D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Answer: D
NEW QUESTION 51
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject is hospitalized due to complications of the product administration.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 52
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Documented agreement
- B. Early collaboration
- C. Follow-up meeting after submission
- D. Frequent communication
Answer: D
NEW QUESTION 53
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 batch number printed on the packaging of the affected
product. - B. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release. - C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product. - D. Ask that the regulatory authority provide the actual product subject to the complaint.
Answer: A
NEW QUESTION 54
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Fishbone analysis
- B. Quality by design analysis
- C. Failure modes, effects, and criticality analysis
- D. Fault tree analysis
Answer: C
NEW QUESTION 55
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the
medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Assess the potential safety risk.
- B. Send a "Dear Dr." letter to customers.
- C. Withdraw the affected product from the markets.
- D. Notify the global regulatory authorities.
Answer: D
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. Inform the institution that granted a medical license to the Pi.
- C. Send a letter of complaint to the Ethics Committee that approved the site.
- D. Terminate the PI and inform the regulatory authorities.
Answer: D
NEW QUESTION 57
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. Initiate a global submission process after all submission data are finalized.
- C. Utilize the STED template to complete global requirements.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
Answer: A
NEW QUESTION 58
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 Madrid system.
- C. File design patents in target countries.
- D. Use the community patent system.
Answer: A
NEW QUESTION 59
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby
increasing access to much needed drugs and devices. - B. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the
manufacturer's promotion for such use. - C. Although the regulatory authority reviews and approves drugs for specific indications, the approval
does not limit the use of those drugs in clinical practice. - D. 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.
Answer: C
NEW QUESTION 60
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. Active-controlled
- B. Cross-over
- C. Placebo-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION 61
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