Module 12 2019

Structured Data in pharma → SPOR

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. 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.

SPOR Data Services

The Organisation for Professionals in Regulatory Affairs