Excellent RAC-GS PDF Dumps With 100% DumpExam Exam Passing Guaranted [Jan-2022]
100% Pass Your RAC-GS Regulatory Affairs Certification (RAC) Global Scope at First Attempt with DumpExam
NEW QUESTION 57
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 the industry representative
- C. After the enactment of the regulation, through a product-specific meeting
- D. Before the enactment of the regulation, through formal comments gathering process
Answer: D
NEW QUESTION 58
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 25: C and 60% RH
- B. 30c C and 65% RH
- C. 30 C and 35% RH
- D. 30: C and 75% RH
Answer: D
NEW QUESTION 59
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 60
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 61
At a recent scientific meeting, Company Y had two booths:
. At one booth, Company Y provided brochures on a completed Phase II study.
. In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed
products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting
that Company Y stop this practice in the future and demanding a formal response to the letter. How
should the regulatory affairs professional at Company Y BEST respond?
- A. Inform the local regulatory authority of the letter and discuss how to respond.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
Answer: B
NEW QUESTION 62
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 63
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?
- A. Inform the authority that the time is not suitable and request a new time
- B. Negotiate with colleagues and the authority to find a better time.
- C. Arrange for an inspection without all intended personnel.
- D. Insist that key personnel be available for the inspection.
Answer: B
NEW QUESTION 64
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Production of Intermediate(s)
- B. Isolation and purification
- C. Physical processing and packaging
- D. Introduction of the API starting material
Answer: C
NEW QUESTION 65
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 66
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices
as long as the marketing application is under review by the regulatory authority. - B. Although the regulatory authority reviews and approves drugs for specific indications, the approval
does not limit the use of those drugs in clinical practice. - C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby
increasing access to much needed drugs and devices. - D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the
manufacturer's promotion for such use.
Answer: B
NEW QUESTION 67
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 68
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 69
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Formulation
- B. Specification
- C. Property
- D. Justification
Answer: D
NEW QUESTION 70
Company X is planning to acquire the rights for a product marketed by Company Y. As part of due
diligence, what is the MOST important information the Company X regulatory affairs professional should
ask senior management to request from Company Y?
- A. Intellectual properly
- B. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 71
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Follow-up meeting after submission
- C. Documented agreement
- D. Early collaboration
Answer: A
NEW QUESTION 72
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 73
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 74
......
Trend for RAC-GS pdf dumps before actual exam: https://www.dumpexam.com/RAC-GS-valid-torrent.html
