The global response to COVID-19 has shone a light on the broader potential for global data standards, including those defined via the International Organization for Standardization (ISO) ...
IDMP data are highly fragmented by internal processes, which could cause duplications, contradictions and ambiguity. Focusing on improving data quality will be a key element of any IDMP data ...
Even now, after a decade of run-up, pharma’s readiness to implement and harness ISO IDMP standards still varies wildly, as does companies’ relative maturity in supporting FAIR data principles, geared ...
Up to now, the pharma industry’s advances in implementing ISO IDMP product data standards have been patchy. New research has looked more closely at companies’ IDMP readiness, as well as their progress ...
The European Medicines Agency (EMA) has published a guide to implementing IDMP data standards that will be ”a game changer” for the life sciences sector. Remco Munnik, who has been working with the EU ...
The European Medicines Agency (EMA) has recently published the second version of its EU IDMP Implementation Guide, and it is a landmark regulation for software vendors and pharma companies alike. This ...
What marketing authorization holders need to know. Since the publication of the EU’s 2012 pharmacovigilance regulation, MAHs have been required to provide specific registered, labelled, and more ...
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