EOM 1352: Fri 7 June 2024, 11:36

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Discovery Park: Wed 13 November 2024, 10:35
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EMA PMS: Capitalising on Centralised Medicinal Product Data – Which Way Now for Regulatory Leaders?

By 2026, IDMP compliance will become more challenging for all pharmaceutical companies operating in the EU, due to the broader adoption of the IDMP data model. Now, all eyes are on the EMA Product Management Services (PMS) – or they next steps. should be. EMA PMS is essentially a centralised platform, designed to streamline the management and exchange of medicinal product information across the EU, and beyond. MAIN5’s Michiel Stam considers the pharma industry’s best next steps.

The “bigger picture” benefits of the ISO Identification of Medicinal Products (IDMP) – international standards for uniquely identifying and describing medicinal products – have been well articulated over the years. Yet it is through the imminent rollout of Product Management Services (PMS) by the European Medicines Agency (EMA) that this wider reality will begin to take shape – in the European Union at least. After much grappling with intricate vocabulary standardisation and compliant data structuring, pharma companies marketing products in the EU will start to glimpse the potential (ultimately) of more tightly linking authorised medicines, product pack and data carrier IDs with the latest marketing status details, electronic patient information and summaries of product characteristics.

Catalyst: Fri 8 November 2024, 14:16
Biosynth: Wed 13 November 2024, 10:18