[Feb 03, 2022] Valid RAC-GS Test Answers & RAC-GS Exam PDF
Valid RAC Regulatory Affairs Certification RAC-GS Dumps Ensure Your Passing
NEW QUESTION 60
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Request documentation from the sub-contractor.
- B. Ask the vendor to take responsibility.
- C. Document and perform audits.
- D. Request an inspection from a regulatory authority.
Answer: C
NEW QUESTION 61
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. Doha Declaration in the TRIPS Agreement
- C. International import and export regulations
- D. The stability of the drug in all zone conditions
Answer: D
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
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. Malfunction protection operated correctly
- C. Deficiency of a device found by the user prior to patient use
- D. Malfunction occurring before the end of service life of the medical device
Answer: A
NEW QUESTION 64
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from
the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory
authorities?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: C
NEW QUESTION 65
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?
- A. Product literature
- B. Essential principles
- C. Instructions for use
- D. Risk analysis
Answer: D
NEW QUESTION 66
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. Labeling
- B. Safety-related reporting
- C. Regulatory application summary
- D. Risk management process
Answer: A
NEW QUESTION 67
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how
long should a sponsor retain the clinical study essential documents?
- A. For a minimum of 10 years after completion of the clinical study
- B. For at least two years after the last approval of an application in an ICH region
- C. Until the product has been discontinued from marketing in all ICH regions
- D. Three years after the last clinical study site was supplied with investigational drugs
Answer: B
NEW QUESTION 68
The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to
serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?
- A. Initiate a mandatory recall of the product in Country Y.
- B. Review alt distribution records and complaints reported in Country Y.
- C. Draft a formal letter to customers in Country Y about this recall.
- D. Prepare the legal team in Country Y for possible litigations.
Answer: B
NEW QUESTION 69
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Contact the marketing department to recall the product.
- B. Request that doctors stop using the product for the off-label indication.
- C. Communicate with the sales department to stop using the promotional materials.
- D. Allow doctors to use the product for the off-label indication.
Answer: C
NEW QUESTION 70
Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A
regulatory authority requires that all labeling for Company Y's products be converted to Company X within
three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet
this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the
situation?
- A. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority. - B. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
requirement and assign responsibilities. - C. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones. - D. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority.
Answer: D
NEW QUESTION 71
Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?
- A. "Product X is effective in all patients with arthritis."
- B. "Product X is safe for arthritis and without side effects."
- C. "Product X is effective for the treatment of arthritis."
- D. "Product X is a guaranteed cure for arthritis."
Answer: C
NEW QUESTION 72
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. Clinical experience
- B. Clinical investigations
- C. Literature search
- D. Adverse event reports
Answer: B
NEW QUESTION 73
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. Randomization scheme and codes
- C. Detailed CV of all investigators
- D. Protocol and protocol amendments
Answer: C
NEW QUESTION 74
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A major safety finding from a newly completed animal carcinogenicity study
- B. A statistically significant increase in the number of deaths in an animal dose finding study
- C. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- D. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
Answer: D
NEW QUESTION 75
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