2022 Latest RAPS RAC-GS Real Exam Dumps PDF
RAC-GS Exam Dumps, RAC-GS Practice Test Questions
NEW QUESTION 53
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. Perform a thorough library search to gather detailed information on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
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. No action is needed in this situation.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
Answer: C
NEW QUESTION 55
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. Regulatory agency
- C. Quality assurance
- D. Quality improvement
Answer: C
NEW QUESTION 56
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. ISO 14971 risk analysis
- B. Failure mode and effect analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: A
NEW QUESTION 57
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Quality by design analysis
- B. Fishbone analysis
- C. Failure modes, effects, and criticality analysis
- D. Fault tree analysis
Answer: C
NEW QUESTION 58
Why is it necessary to run supplemental safety pharmacology studies?
- A. To substitute the utilization of GLP
- B. To comply with regulatory authority requirements related to clinical studies
- 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 59
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
- A. Introducing a new analytical method
- B. Deleting an ingredient of the drug product
- C. Strengthening a precaution to the product labeling
- D. Deleting a drug substance
Answer: C
NEW QUESTION 60
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Malfunction protection operated correctly
Answer: A
NEW QUESTION 61
After submission to the regulatory authority, a substantial error was found in the application. In order to
resolve this issue, what should be done FIRST?
- A. Verify the procedure in the regulation for the corrections.
- B. Contact the legal department and ask them how to proceed.
- C. Resubmit the entire package.
- D. Inform upper management immediately.
Answer: A
NEW QUESTION 62
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 63
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. All senior management from the main office
- C. As many as government attendees
- D. The minimum number of attendees necessary to address the issues
Answer: D
NEW QUESTION 64
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. The time frame in which the patent will expire
- B. International import and export regulations
- C. The stability of the drug in all zone conditions
- D. Doha Declaration in the TRIPS Agreement
Answer: C
NEW QUESTION 65
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. Send a "Dear Dr." letter to customers.
- B. Withdraw the affected product from the markets.
- C. Assess the potential safety risk.
- D. Notify the global regulatory authorities.
Answer: D
NEW QUESTION 66
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Deny the auditor access to the room and retrieve only the requested records.
Answer: A
NEW QUESTION 67
A company is developing a device-drug combination product. Which of the following should be evaluated
FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 68
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Summarize regulatory documents and history and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - C. Obtain competitor research and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: A
NEW QUESTION 69
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be in conflict with the laws of the country to which it is intended for export.
- C. The product must not be labeled on the outside of the shipping package that it is intended for export.
- D. The product must not be in accord with the specifications of the foreign purchaser.
Answer: B
NEW QUESTION 70
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Consumer
- B. Distributor
- C. Manufacturer
- D. Regulatory authority
Answer: C
NEW QUESTION 71
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. Adverse event reports
- B. Literature search
- C. Clinical experience
- D. Clinical investigations
Answer: D
NEW QUESTION 72
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