Proper and full implementation of the ISO-IDMP standard is expected by regulatory bodies in the year 2023. It is therefore crucial for pharmaceutical companies to implement a solution that not only solves that issue but is also sustainable.
Various Pharmaceutical companies, the Pistoia Alliance and Accurids have come together to create a. IDMP Ontology.
Having a well-defined ontology that bridges the gap between regional and functional perspectives on common substance-related data items and global and scientifically objective representations is crucial. Our project's purpose is to create an IDMP Ontology that enables deep, semantic interoperability based on FAIR principles to improve and supplement the existing ISO IDMP standards.
The governance of critical IDMP standards and implementations is not delegated to a single governing body. Diverse IDMP implementations across geographical areas and legal domains are already leading to variations in interpretation between implementing entities.
Given the lack of semantic coherence among regulatory bodies, there is a concern that regulatory compliance requirements may result in high integration and interoperability costs, limiting the benefits of IDMP in medication safety, innovation, and other areas.
Organizations will struggle with data concerns, such as the requirement to map product data across the company and throughout the product lifecycle, rather than focusing on developing new medications.
Today’s IDMP implementations in various organizations are diverse, built-in silos, not fully standardized and have already created inconsistencies of interpretation.
As a solution to the mentioned challenges, the IDMP core ontology has been developed by the Pistoia Alliance, in co-operation with various big pharmaceutical companies. The goal is to enable deep, semantic interoperability based on FAIR data principles to augment the existing ISO IDMP standards of the European Medical Agency.
With this IDMP Ontology, corporations can ascend to a decreased risk of compliance issues as well as burdens from a regulatory side, providing a decisive advantage in the overall market situation.
This will ultimately enable entirely new ways of collaboration and enable early adopters to gain a competitive advantage in innovation, drug safety and overall operational efficiency.
The Pistoia Alliance was chosen to administer this program, which aims to develop a minimum viable product (MVP) ontology that adds value to the ISO IDMP standards for data usability across organizational borders and regulatory countries. For this initiative, the Pistoia Alliance has assembled a core team comprising pharmaceutical players, regulatory authorities, standards organizations, non-profit organizations, and solution suppliers.
Building a custom solution IDMP software poses many hurdles, such as high cost, long time to deployment as well as ongoing costs of maintenance. It is therefore economically as well as functionally smart to implement an IDMP software that is already deployed and that has been developed in accordance with various pharmaceutical companies.
You can schedule a demo to learn more about your individual use cases and the benefits your corporation can realise through the simple implementation of Accurids: