[2023] Pass Key features of RAC-US Course with Updated 100 Questions [Q17-Q33]

QUESTION 17
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 18
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

QUESTION 19
Who has the PRIMARY responsibility for recall of products with quality defects?

QUESTION 20
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?

QUESTION 21
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

QUESTION 22
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?

QUESTION 23
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

QUESTION 24
According to ICH, which of the following components of study information is NOT required in a clinical study report?

QUESTION 25
During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

QUESTION 26
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?

QUESTION 27
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?

QUESTION 28
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?

QUESTION 29
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 30
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

QUESTION 31
What is the LAST stage in the development of a quality risk management process for a medical device?

QUESTION 32
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 33
Which question is pertinent to demonstrate a new pharmaceutical’s effectiveness during evaluation by a reimbursement agency?