Updated Aug-2021 Test Engine to Practice Test for RAC-GS Exam Questions and Answers!
Regulatory Affairs Certification (RAC) Global Scope Certification Sample Questions and Practice Exam
NEW QUESTION 15
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 16
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Specification
- B. Justification
- C. Formulation
- D. Property
Answer: B
NEW QUESTION 17
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. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority. - C. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones. - D. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority.
Answer: B
NEW QUESTION 18
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. Ask the vendor to take responsibility.
- B. Request documentation from the sub-contractor.
- C. Document and perform audits.
- D. Request an inspection from a regulatory authority.
Answer: C
NEW QUESTION 19
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical
device?
- A. Risk estimation
- B. Risk management
- C. Risk control
- D. Risk analysis
Answer: D
NEW QUESTION 20
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 21
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 22
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X
would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about
Company Y?
- A. Perform a thorough library search to gather detailed information on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Recruit a professional to gather confidential intelligence on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION 23
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. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION 24
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. Product release and validation
- B. Concept development and validation
- C. Early technical design and product release
- D. Concept development and early technical design
Answer: D
NEW QUESTION 25
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. Clinical trial data
- B. Safety issues
- C. Intellectual properly
- D. Marketing materials
Answer: B
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. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 27
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Isolation and purification
- B. Production of Intermediate(s)
- C. Introduction of the API starting material
- D. Physical processing and packaging
Answer: D
NEW QUESTION 28
The API used for an approved drug product conforms to international monograph specifications and local
pharmacopeia; however, the international monograph specifications of the API will be changing soon.
Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Confirm that the international monograph change is not related to local pharmacopeia.
- B. Prepare the international monograph change submission first and then prepare the local change when
required. - C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Transfer the notice of the upcoming international monograph change to QA for further processing.
Answer: D
NEW QUESTION 29
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 30
A company is developing a new product for the global market. A new international guideline will
recommend relevant studies in the pediatric population, and the guideline will be effective before the
approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this
guideline on the successful registration of the new product?
- A. The company should initiate the required pediatric studies immediately to avoid costly delays to the
current registration plan. - B. The company should consult with relevant regulatory authorities to determine the potential impact on
the current registration plan. - C. The new guideline has no impact on the current registration plan since all relevant registration studies
are almost completed. - D. The new guideline has no impact on the current registration plan, but the company must be prepared to
defend its decision.
Answer: B
NEW QUESTION 31
A company is considering the development of a medical device similar to those already available. Which
of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Clinical investigations
- B. Clinical experience
- C. Adverse event reports
- D. Literature search
Answer: A
NEW QUESTION 32
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30 C and 35% RH
- B. 30c C and 65% RH
- C. 30: C and 75% RH
- D. 25: C and 60% RH
Answer: C
NEW QUESTION 33
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. Regulatory application summary
- B. Risk management process
- C. Labeling
- D. Safety-related reporting
Answer: C
NEW QUESTION 34
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be labeled on the outside of the shipping package that it is intended for export.
- B. The product must not be sold or offered for sale in domestic commerce.
- C. The product must not be in accord with the specifications of the foreign purchaser.
- D. The product must not be in conflict with the laws of the country to which it is intended for export.
Answer: D
NEW QUESTION 35
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. Hazard and operability study
- B. Failure mode and effect analysis
- C. ISO 14971 risk analysis
- D. Fault tree analysis
Answer: C
NEW QUESTION 36
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Inform the company's senior management and arrange an emergency meeting
- B. Arrange for additional testing of the product at the testing facility.
- C. Consult with the company's legal department regarding options.
- D. Obtain a copy of the proposed regulation and analyze the impact.
Answer: D
NEW QUESTION 37
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 whiten teeth."
- D. "It will make you look younger."
Answer: A
NEW QUESTION 38
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. Previous actions taken by regulatory authorities on similar products
- B. Regulatory requirements for labeling and packaging
- C. Capacity of the manufacturing facilities to fully produce the new product
- D. Potential clinical sites for the Phase III clinical trial
Answer: A
NEW QUESTION 39
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