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NEW QUESTION 49
Who has the PRIMARY responsibility for recall of products with quality defects?

A. Regulatory authorityB. ConsumerC. ManufacturerD. Distributor

Answer: C

 

NEW QUESTION 50
In which section of the ICH Common Technical Document will the overview of clinical data appear?

A. Module 3B. Module 4C. Module 2D. Module 1

Answer: C

 

NEW QUESTION 51
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?

A. Acknowledge receipt of the letter in a written response but do nothing further.B. Inform Company X that it has no right to send such a letter and do nothing further.C. Inform the local regulatory authority of the letter and discuss how to respond.D. Inform the legal department of the letter and discuss how to respond.

Answer: D

 

NEW QUESTION 52
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?

A. Analyze the impact of the international monograph change on the local pharmacopeia.B. Transfer the notice of the upcoming international monograph change to QA for further processing.C. Confirm that the international monograph change is not related to local pharmacopeia.D. Prepare the international monograph change submission first and then prepare the local change when required.

Answer: B

 

NEW QUESTION 53
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

A. Product registrationB. Product stabilityC. Product formulationD. Product requirements

Answer: B

 

NEW QUESTION 54
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