QUESTION: 5

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

Product stability
Product registration
Product formulation
Product requirements

Answer(s): A

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QUESTION: 6

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?

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

Answer(s): C

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