Module 12 Presentations

xEVMPD-SPOR-IDMP

ISO IDMP

xEVMPD

xEVMPD

Directive 2010/84/EC

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No structure

Regulation (EU) No 1235/2010

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July 2012 implemented

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• 1 registration ~ 80 data elements (RMS + MedDRA)

ISO IDMP

• Should have been implemented in 2016, but standard not ready/mature

• Standard now ready and implementation for now foreseen in different steps (Iterations)

SPOR

• In order to implement ISO IDMP, EMA started Master Data Management project for: Substances, Products, Organizations and Referentials

• Product data (PMS) is used through PLM eAF

• 1 registration ~ 150 data elements

The Organisation for Professionals in Regulatory Affairs