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NEW QUESTION 34
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. Perform a thorough library search to gather detailed information on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Recruit a professional to gather confidential intelligence on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION 35
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 36
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 37
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Inadequate training
- B. Late and/or incorrect deliverables
- C. Causes of non-conformities
- D. Adverse environmental impacts
Answer: C
NEW QUESTION 38
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. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION 39
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- B. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
- C. A major safety finding from a newly completed animal carcinogenicity study
- D. A statistically significant increase in the number of deaths in an animal dose finding study
Answer: B
NEW QUESTION 40
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?
- A. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - B. The manufacturer's experience level with the type of IVD medical device is limited.
- C. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - D. The device incorporates well-established technology that is already present in the market.
Answer: B
NEW QUESTION 41
Why is it necessary to run supplemental safety pharmacology studies?
- A. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- B. To comply with regulatory authority requirements related to clinical studies
- C. To substitute the utilization of GLP
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: A
NEW QUESTION 42
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. Communicate with the sales department to stop using the promotional materials.
- B. Allow doctors to use the product for the off-label indication.
- C. Request that doctors stop using the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: A
NEW QUESTION 43
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level,
the medical device continues to have unacceptable risks. However, the development team wants to
continue development. Which is the BEST recommendation to make in this situation?
- A. Discontinue the project.
- B. Add a warning in the IFU.
- C. Perform another risk-benefit analysis.
- D. Redesign the device.
Answer: D
NEW QUESTION 44
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 stability of the drug in all zone conditions
- B. Doha Declaration in the TRIPS Agreement
- C. The time frame in which the patent will expire
- D. International import and export regulations
Answer: A
NEW QUESTION 45
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 requirements
- B. Product registration
- C. Product stability
- D. Product formulation
Answer: C
NEW QUESTION 46
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 47
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 Secretariat
- C. The country's regulatory authority
- D. The ISO technical committee in charge of the area
Answer: A
NEW QUESTION 48
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Import license
- B. Product license
- C. Export license
- D. Site license
Answer: D
NEW QUESTION 49
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