Free RAC-GS Sample Questions and 100% Cover Real Exam Questions (Updated 100 Questions)
Download Real RAPS RAC-GS Exam Dumps Test Engine Exam Questions
NEW QUESTION 10
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. Use the community patent system.
- B. File patents of interest in target countries.
- C. Use the Madrid system.
- D. File design patents in target countries.
Answer: B
NEW QUESTION 11
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 ISO national member body
- B. The ISO technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 12
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 13
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 14
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. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
Answer: B
NEW QUESTION 15
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 16
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. Placebo-controlled
- B. Cross-over
- C. Active-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION 17
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 stability
- B. Product requirements
- C. Product formulation
- D. Product registration
Answer: A
NEW QUESTION 18
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 19
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. Contact the trade association for advice.
- C. Prepare documents for the files.
- D. Communicate with the relevant internal departments.
Answer: D
NEW QUESTION 20
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 21
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. Plasma pooling
- B. Plasma fractionation
- C. Individual plasma donation
- D. Product distribution
Answer: D
NEW QUESTION 22
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 23
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Request a meeting with the regulatory authority to discuss the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 24
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. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 25
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?
- A. Safety and efficacy
- B. Compatibility and safety
- C. Volume and material
- D. Efficacy and material
Answer: B
NEW QUESTION 26
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. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 27
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk reduction
- C. Risk evaluation
- D. Risk analysis
Answer: A
NEW QUESTION 28
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Local reimbursement requirements
- B. Training program for sales people
- C. Service operation procedures .
- D. Written procedure for product traceability
Answer: B
NEW QUESTION 29
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 30
A process is ultimately validated to ensure which of the following?
- A. The process consistently meets the desired Quantity standards
- B. The process meets the quality system requirements.
- C. The process consistently produces the desired results.
- D. The process meets the regulatory requirements.
Answer: C
NEW QUESTION 31
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 32
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 33
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Causes of non-conformities
- B. Inadequate training
- C. Adverse environmental impacts
- D. Late and/or incorrect deliverables
Answer: A
NEW QUESTION 34
......
New RAC-GS exam dumps Use Updated RAPS Exam: https://www.trainingdumps.com/RAC-GS_exam-valid-dumps.html
Verified RAC-GS Dumps Q&As - RAC-GS Test Engine with Correct Answers: https://drive.google.com/open?id=1Q97Dt8pqZrYz46YX3qxWNbqw3l0Vs6la
