100% Passing Guarantee - Brilliant RAC-GS Exam Questions PDF [Nov-2021]
RAC-GS Dumps 2021 - NewRAPS RAC-GS Exam Questions
NEW QUESTION 27
Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical
Properties and Formulation" section of an IB?
- A. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation
method of the finished product - B. A detailed summary of the physical and chemical properties of the drug product with a signed expert
statement addressing the suitability and stability of the formulation for its intended use - C. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage
and handling of the dosage form: and a description of the formulation - D. A review of available data to support the determination of the chemical structure and physical attributes
of the drug substance plus batch analysis and stability data for the finished formulation
Answer: C
NEW QUESTION 28
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?
- A. Volume and material
- B. Compatibility and safety
- C. Efficacy and material
- D. Safety and efficacy
Answer: B
NEW QUESTION 29
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 30
A regulatory affairs professional has submitted a package for regulatory review. According to the
regulation, the regulatory authority will need to respond within 90 days of submission. If there is no
response after the deadline, what is the BEST approach?
- A. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission. - B. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission. - C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time. - D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions.
Answer: D
NEW QUESTION 31
In order to develop a global drug product, what is the MOST important environmental characteristic to
consider in the country of intended use?
- A. Product registration
- B. Product stability
- C. Product formulation
- D. Product requirements
Answer: B
NEW QUESTION 32
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized due to complications of the product administration.
- B. Subject is hospitalized for the purpose of product administration.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject's hospitalization is prolonged during the clinical trial.
Answer: B
NEW QUESTION 33
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. Capacity of the manufacturing facilities to fully produce the new product
- C. Regulatory requirements for labeling and packaging
- D. Potential clinical sites for the Phase III clinical trial
Answer: A
NEW QUESTION 34
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 a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study. - C. Perform both identification and non-clinical qualification studies concurrently.
- D. Perform either an identification study or a non-clinical qualification study.
Answer: A
NEW QUESTION 35
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: A
NEW QUESTION 36
What are the MOST important elements that global regulatory agencies want to know before approving a
new product for sale in their countries?
- A. Quality and effectiveness
- B. Safety and effectiveness
- C. Safety and failure risk
- D. Quality and failure risk
Answer: B
NEW QUESTION 37
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. Proposed product route and frequency of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
Answer: C
NEW QUESTION 38
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Export license
- B. Import license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 39
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
- A. Deleting an ingredient of the drug product
- B. Introducing a new analytical method
- C. Deleting a drug substance
- D. Strengthening a precaution to the product labeling
Answer: D
NEW QUESTION 40
Why is it necessary to run supplemental safety pharmacology studies?
- A. To comply with regulatory authority requirements related to clinical studies
- B. To substitute the utilization of GLP
- C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: C
NEW QUESTION 41
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 42
According to ICH, which of the following components of study information is NOT required in a clinical
study report?
- A. Detailed CV of all investigators
- B. Randomization scheme and codes
- C. Protocol and protocol amendments
- D. List of lECs or lRBs
Answer: A
NEW QUESTION 43
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 community patent system.
- C. File design patents in target countries.
- D. Use the Madrid system.
Answer: A
NEW QUESTION 44
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 technical committee in charge of the area
- C. The ISO national member body
- D. The ISO Secretariat
Answer: C
NEW QUESTION 45
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Prepare documents for the files.
- B. Communicate with the relevant internal departments.
- C. Request a permanent waiver from the new regulation.
- D. Contact the trade association for advice.
Answer: B
NEW QUESTION 46
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage
should the manufacturer be able to trace back the product?
- A. Product distribution
- B. Plasma fractionation
- C. Plasma pooling
- D. Individual plasma donation
Answer: A
NEW QUESTION 47
A global company is developing a sophisticated implantable medical device that is coated with antibiotics
and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a
medical device. The same product, without the antibiotics and biologics, is marketed as a medical device
in Country Y. The company is proposing to start marketing the coated device in Country Y. Which
regulatory approach should the company propose?
- A. Apply for review of the additional part of the product as a pharmaceutical product in Country
- B. Submit the product as a medical device in Country Y as the product is already marketed in Country X
as a medical device. - C. Examine decisions made about similar products in Country Y to propose the classification of the
product. - D. Submit the product for review as a pharmaceutical product in Country Y.
Answer: A
NEW QUESTION 48
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 49
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