Ultimate Guide to Prepare RAC-GS Certification Exam for RAC Regulatory Affairs Certification in 2021
Use Real RAC-GS Dumps - RAPS Correct Answers updated on 2021
NEW QUESTION 50
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 a product-specific meeting
- 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 the industry representative
Answer: B
NEW QUESTION 51
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. Protocol and protocol amendments
- C. Randomization scheme and codes
- D. Detailed CV of all investigators
Answer: D
NEW QUESTION 52
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 53
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 54
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 55
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 56
The requirements for document control are located in which of the following documents?
- A. IEC 60601
- B. ISO 13485
- C. WHO guidelines
- D. ICH guidelines
Answer: B
NEW QUESTION 57
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 58
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 regulatory documents and history and provide the information to R&D.
- B. Summarize regulatory documents and history and provide the information to the management team.
- C. Obtain competitor research and provide the information to the management team.
- D. Ask the trade association representative to provide an overview of the new product area to the
marketing team.
Answer: B
NEW QUESTION 59
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 60
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Vigilance procedure to notify the regulatory authorities about serious incidents
- B. Systematic procedure to review published scientific journals
- C. Systematic procedure to review experiences with the products in use
- D. Vigilance procedure to ensure the full traceability of the products
Answer: D
NEW QUESTION 61
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: A
NEW QUESTION 62
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 63
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. Request a permanent waiver from the new regulation.
- B. Prepare documents for the files.
- C. Contact the trade association for advice.
- D. Communicate with the relevant internal departments.
Answer: D
NEW QUESTION 64
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 65
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 66
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 67
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