Module 12 2019

SPOR

xEVMPD

IDMP

Master data = any non-transactional information considered to play a key role in the core operation of a business & re-used for multiple purposes.

Substances: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute medicinal product.

Products: Harmonised data and definitions to uniquely identify medicinal product based on regulated information.

SPOR Data Services

Organisations: Data that comprises of organisation name and location address data for organisations: MAH, sponsors, regulatory authorities, manufacturers.

Referentials: Lists of terms ( controlled vocabularies ) used to describe attributes of products.

The Organisation for Professionals in Regulatory Affairs