Question No :01
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. Enter into an agreement with Company Y to perform due diligence.
B. Recruit a professional to gather confidential intelligence on Company Y.
C. Request the needed information from the Board of Directors of Company Y.
D. Perform a thorough library search to gather detailed information on Company Y.
Answer: A
Question No :02
Which of the following is NOT required to be included in a marketing application?
A. Final printed label
B. Quality, safety, and efficacy Information
C. Administrative forms
D. Evidence of fee payment
Answer: D
Question No :03
According to ISO 14971, what is the FIRST step when developing a risk management plan
for a medical device?
A. Risk estimation
B. Risk analysis
C. Risk control
D. Risk management
Answer: B
Question No :04
According to the GHTF, which of the following is NOT an exemption rule when evaluating
the decision to report an adverse event?
A. Deficiency of a device found by the user prior to patient use
B. Adverse event caused by patient conditions
C. Malfunction occurring before the end of service life of the medical device
D. Malfunction protection operated correctly
Answer: B
Question No :05
What is the LAST stage in the development of a quality risk management process for a
medical device?
A. Risk analysis
B. Risk reduction
C. Risk acceptance
D. Risk evaluation
Answer: C
Question No :06
Which of the following is NOT considered a serious adverse event in a cardiovascular
clinical trial?
A. Subject is hospitalized due to complications of the product administration.
B. Subject is hospitalized for the purpose of product administration.
C. Subject's hospitalization is due to an unscheduled hip operation.
D. Subject's hospitalization is prolonged during the clinical trial.
Answer: B
Question No :07
Which of the following situations does NOT require rapid communication to regulatory
authorities?
A. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
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: A
Question No :08
Which of the following changes to a drug product is MOST likely to be implemented without
prior regulatory authority approval?
A. Deleting an ingredient of the drug product
B. Deleting a drug substance
C. Introducing a new analytical method
D. Strengthening a precaution to the product labeling
Answer: D
Question No :09
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?
A. Contact the regulatory authority to argue that its conclusions are wrong.
B. Contact the regulatory authority to discuss its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
D. Wait for the regulatory authority's final publication on its findings.
Answer: B
Question No :10
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory
authority for review and approval. The regulatory authority issues the company a written
commitment that if the studies are completed as outlined in the protocol and the results
meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all prespecified criteria, the company receives a letter from the regulatory authority stating that it
no longer believes that the product will be approved based on a recent withdrawal of a
similar product in another country.
What is the BEST response?
A. Notify the regulatory authority regarding Its obligation to honor the commitment to
approve the application.
B. Consult with the legal department to discuss the best course of action.
C. Review the regulatory guidelines to determine how to proceed.
D. Request a meeting with the regulatory authority to discuss the application.
Answer: D
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