QUESTION 42
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

QUESTION 43
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 44
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 45
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

QUESTION 46
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 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?

QUESTION 48
A process is ultimately validated to ensure which of the following?

QUESTION 49
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?

QUESTION 50
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

QUESTION 51
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

QUESTION 52
Which of the following is the PRIMARY purpose of an audit report?

QUESTION 53
Which of the following statements regarding the off-label use of drugs is CORRECT?

QUESTION 54
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

QUESTION 55
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

QUESTION 56
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

QUESTION 57
Which of the following is MOST appropriate for the purpose of lot release of biologics?

QUESTION 58
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?

QUESTION 59
According to ICH, which of the following components of study information is NOT required in a clinical study report?

QUESTION 60
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

QUESTION 61
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

QUESTION 62
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 63
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

QUESTION 64
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 65
What is the LAST stage in the development of a quality risk management process for a medical device?

QUESTION 66
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?