Regular Free Updates RAC-GS Dumps Real Exam Questions Test Engine Feb 20, 2023 [Q39-Q58]

QUESTION 39
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?

QUESTION 40
Who has the PRIMARY responsibility for recall of products with quality defects?

QUESTION 41
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?

QUESTION 42
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?

QUESTION 43
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

QUESTION 44
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug
produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly
different color and break easily.
Which of the following actions should the regulatory affairs professional take?

QUESTION 45
According to ICH, how many stability time points are normally required to establish a two-year shelf life for
a product?

QUESTION 46
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?

QUESTION 47
A company’s product was approved by a regulatory authority with the condition that further studies must
be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the
LEAST effective way to achieve this goal?

QUESTION 48
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?

QUESTION 49
The safety database for an anti-hypertensive drug consists of the following:
. 461 patients exposed for three months
. 343 patients exposed for six months
. 112 patients exposed for nine months
. 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

QUESTION 50
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?

QUESTION 51
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?

QUESTION 52
A company is developing a new product for the global market. A new international guideline will
recommend relevant studies in the pediatric population, and the guideline will be effective before the
approval of the company’s new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this
guideline on the successful registration of the new product?

QUESTION 53
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?

QUESTION 54
Which of the following situations does NOT require rapid communication to regulatory authorities?

QUESTION 55
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?

QUESTION 56
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?

QUESTION 57
In which section of the ICH Common Technical Document will the overview of clinical data appear?

QUESTION 58
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?