SPOR Data Management Services.
What is SPOR?
SPOR is an acronym for Substance, Product, Organization and Referential and refers to the EMA’s program to implement the ISO IDMP Identification of Medicinal Products) standards which aim to “to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ ” – EMA/732656/2015. European Medicines Agency. Information Management Division. 29 November 2016.
The ISO IDMP framework is comprised of 5 standards – ISO 11238 (Substances), ISO 11239 (Dosage, Units, Packaging etc.), ISO 11240 (Units of Measurement), ISO 11616 (Regulated pharmaceutical product information) and ISO 11615 (Regulated medicinal product information).
The need for SPOR has arisen to comply with this framework and for various data integrity and accuracy reasons such as different names for substances, different names used for the same organization, and generally inconsistent data across databases.
The SPOR data aims therefore to bring information stored in different systems into one high-quality, consistent master data format that provides benefits for multiple stakeholders.
To manage SPOR the EMA has set up a data portal where companies can register and update their related data with four data management services:
Substance Management Services (SMS).
Product Management Services (PMS).
Organizations Management Services (OMS).
Referential Management Services (RMS).
Why use Arriello’s SPOR data Management service?
Our experienced team can keep you fully in step with these EMA developments by efficiently managing all your SPOR data and organization profile as a SPOR user and SPOR Super user.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
