Which of the following best describes the appropriate criteria for initiating Cohort Event Monitoring (CEM) in pharmacovigilance?

Question

Which of the following best describes the appropriate criteria for initiating  Cohort Event Monitoring (CEM)  in pharmacovigilance?

Answer

When a drug reaches the end of its patent life

Answer

When a medication becomes available over-the-counter (OTC)

Answer

When a drug has no reported adverse events during pre-marketing trials

Answer

When a new chemical entity or a new class of medicine is introduced, especially if it has a history of potential adverse effects

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