EMT Practice Test

1. Question Content...

---

Question1: 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?

Question2: In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

Question3: During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?

Question4: A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

Question5: 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?

Question6: The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

Question7: Which of the following BEST describes the purpose of the ICH?

Question8: 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?

Question9: 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?

Question10: Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

Question11: Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

Question12: 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?

Question13: According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Question14: A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

Question15: 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?

Question16: During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

Question17: According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

Question18: 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?

Question19: A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

Question20: One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

Question21: You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

Question22: In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

Question23: 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?

Question24: In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

Question25: Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

Question26: According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

Question27: A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Question28: A process is ultimately validated to ensure which of the following?

Question29: Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

Question30: A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

Question31: The requirements for document control are located in which of the following documents?

Question32: 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?

Question33: In which section of the ICH Common Technical Document will the overview of clinical data appear?

Question34: 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?

Question35: Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

Question36: After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?