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NEW QUESTION 24
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

• A. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
• B. Consult with colleagues about the request.
• C. Initiate testing immediately to ensure compliance.
• D. Contact the regulatory authority that issued this request and discuss the requirement.

Answer: D

NEW QUESTION 25
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

• A. Assess the potential safety risk.
• B. Notify the global regulatory authorities.
• C. Send a "Dear Dr." letter to customers.
• D. Withdraw the affected product from the markets.

Answer: B

NEW QUESTION 26
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?

• A. Inform the institution that granted a medical license to the Pi.
• B. Increase the frequency of monitoring visits.
• C. Send a letter of complaint to the Ethics Committee that approved the site.
• D. Terminate the PI and inform the regulatory authorities.

Answer: D

NEW QUESTION 27
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?

• A. Identify countries where special requirements exist during the product development phase.
• B. Plan regulatory approval update meetings with senior management and stakeholders.
• C. Initiate a global submission process after all submission data are finalized.
• D. Utilize the STED template to complete global requirements.

Answer: A

NEW QUESTION 28
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

• A. Safety and failure risk
• B. Quality and failure risk
• C. Quality and effectiveness
• D. Safety and effectiveness

Answer: D

NEW QUESTION 29
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