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RAPS RAC-GS exam covers a wide range of topics related to regulatory affairs, including regulatory strategies, submissions, compliance, and post-approval activities. RAC-GS exam is divided into four different modules, each of which focuses on a specific area of regulatory affairs. The modules include: Global Strategy and Governance, Product Development and Regulation, Regulatory Submissions and Approvals, and Post-Marketing Regulatory Activities.
NEW QUESTION # 44
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 B
- C. Class C
- D. Class A
Answer: C
NEW QUESTION # 45
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. Recruit a professional to gather confidential intelligence on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Enter into an agreement with Company Y to perform due diligence.
- D. Perform a thorough library search to gather detailed information on Company Y.
Answer: C
NEW QUESTION # 46
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 product route and frequency of administration
- B. Proposed dose and volume of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
Answer: C
NEW QUESTION # 47
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. Analytical
- B. Regulatory
- C. Production
- D. Quality
Answer: D
NEW QUESTION # 48
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 # 49
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. Physical processing and packaging
- C. Production of Intermediate(s)
- D. Introduction of the API starting material
Answer: B
NEW QUESTION # 50
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. Placebo-controlled
- C. Cross-over
- D. Dose-ranging
Answer: C
NEW QUESTION # 51
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 an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study. - B. Perform either an identification study or a non-clinical qualification study.
- C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study. - D. Perform both identification and non-clinical qualification studies concurrently.
Answer: A
NEW QUESTION # 52
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. Information deemed appropriate by the regulatory authority
- B. The process information and analytical result of Company Y API
- C. The process information and the comparative analytical result of APIs from both companies
- D. The process information and analytical result of Company X API
Answer: C
NEW QUESTION # 53
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Fault tree analysis
- B. Failure modes, effects, and criticality analysis
- C. Fishbone analysis
- D. Quality by design analysis
Answer: B
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. Assess the impact of the changes.
- C. Review the stability data for the changes.
- D. Establish validation procedures.
Answer: A
NEW QUESTION # 55
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Malfunction occurring before the end of service life of the medical device
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction protection operated correctly
- D. Adverse event caused by patient conditions
Answer: D
NEW QUESTION # 56
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?
- A. Efficacy and material
- B. Compatibility and safety
- C. Safety and efficacy
- D. Volume and material
Answer: B
NEW QUESTION # 57
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Early collaboration
- B. Frequent communication
- C. Documented agreement
- D. Follow-up meeting after submission
Answer: B
NEW QUESTION # 58
One month prior to the anticipated approval date for your product, the marketing application that you
submitted to a major regulatory authority has become the subject of an advisory committee meeting of
experts convened by the regulatory authority. The advisory committee members unanimously vote not to
approve your product because of a safety concern. Two days after the advisory committee meeting, the
regulatory authority requests additional information to support the safety of your product. Assuming you
have no additional data to provide, which of the following would be your MOST appropriate response to
the regulatory authority's request?
- A. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference." - B. "We disagree with the advisory committee's decision because the committee neglected the thorough
safety analysis that we provided." - C. "We have no additional information to provide at this time, but we can perform an additional analysis for
a specific safety concern, if necessary." - D. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval."
Answer: C
NEW QUESTION # 59
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. Inform the institution that granted a medical license to the Pi.
- B. Send a letter of complaint to the Ethics Committee that approved the site.
- C. Terminate the PI and inform the regulatory authorities.
- D. Increase the frequency of monitoring visits.
Answer: C
NEW QUESTION # 60
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be in accord with the specifications of the foreign purchaser.
- B. The product must not be labeled on the outside of the shipping package that it is intended for export.
- C. The product must not be in conflict with the laws of the country to which it is intended for export.
- D. The product must not be sold or offered for sale in domestic commerce.
Answer: C
NEW QUESTION # 61
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The RAC-GS exam is designed to test the knowledge and skills of regulatory professionals in a variety of areas, including global regulatory requirements, product development, regulatory submissions, and post-market surveillance. RAC-GS exam is divided into four main sections: Global Regulatory Environment, Product Development, Regulatory Submissions, and Post-Market Surveillance. Each section is designed to test a candidate's understanding of the key concepts and practices related to regulatory affairs, and the exam is designed to be challenging and comprehensive.
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