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Good Data Discipline: Responding to new XEVMPD Maintenance Guidelines

Read our article in DIA’s Global Forum

At the end of January 2014, formal guidelines were issued concerning the way updates must be made to European pharmacovigilance data. Miranda Pothiawala, director at Samarind, discusses the implications now that tight timeframes have been set for getting submitted product data in order.

As of two years ago, any life sciences company distributing products in Europe has been subject to a mandate to submit comprehensive product information and documentation to a central electronic database – the EudraVigilance Medicinal Product Dictionary (EVMPD) – in the interests of improving patient safety.

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