Asphalion offers a full range of services to provide a comprehensive support for data compliance for:
Being a reference point for xEVMPD services, we are fully ready to support companies with:
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.
The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.
The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:
EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.
SPOR comes from:
There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).
SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.
Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.
Effective data management involves significant effort, is time-consuming and costly.
Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.
SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.
Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.
Asphalion offers a full range of services to provide a comprehensive support for data compliance for:
Being a reference point for xEVMPD services, we are fully ready to support companies with:
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.
The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.
The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:
EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.
SPOR comes from:
There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).
SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.
Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.
Effective data management involves significant effort, is time-consuming and costly.
Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.
SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.
Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.
Regulatory Operations: Data Management Solutions
At Asphalion we can give you support and help you navigate through the awareness process and work with you to be ISO IDMP compliant whether you have, need or can’t yet access a RIM system.
Importance of 3rd Acknowledgement management in the context of data migration to PMS
⚠️ Managing EMA’s 3rd ACK is a crucial step in the context of migrating xEVMPD data into PMS, aimed at preventing and minimizing inconsistent data input into both the PMS database and eAF.
If you need further information or wish to explore how we can assist you during this transition:
Contact us!
If you need further information or wish to explore how we can assist you during this transition:
Contact us!
If you need further information or wish to explore how we can assist you during this transition:
Contact us!
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This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
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