Transition plan from Article 57/XEVMPD data submission to SPOR
In the context of the implementation of the ISO IDMP standards, the European Medicines Agency (EMA) is establishing services to support the management of master data, i.e. substance, product, organisation and referential (collectively referred to as 'SPOR') data.
The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. The phased implementation plan envisages the prioritisation of the 'Referentials' and the 'Organisation' management services (RMS and OMS) in 2016 with the view of making them available in 2017.
#GoodClinicalPractices #GoodManufacturingPractices #RegulatoryAffairsHuman #LegislationClinicalResearch #LegislationPharmacovigilance #LegislationQualityManagement #RegulatoryAffairsVeterinary #LegislationRegulatoryAffairs
