Glossary

Designated Medical Event (DME)

Serious and rare medical event that is often causally associated with drugs across multiple pharmacological / therapeutic classes. Even small number of reports of such event can trigger a signal and require special attention. The EMA maintains a list of MedDRA Preferred Terms that identifies DMEs.

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Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

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