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Pharma IT Insights
IDMP Gap Analysis for the transition from xEVMPD to PMS
Bridging the Compliance Gap
By Daniel Isaac Kemajou Njamen
September 26, 2024
Pharma IT Insights
Bridging the Compliance Gap: IDMP Gap Analysis for the transition from xEVMPD to PMS
By Daniel Isaac Kemajou Njamen
September 27, 2024
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In the pharmaceutical industry, compliance with global standards like the Identification of Medicinal Products (IDMP) is crucial for ensuring the accuracy of medicinal data, safeguarding public health, and maintaining regulatory approval
With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. This transition heightens the need to align internal systems with public health platforms to avoid regulatory pitfalls and preserve public trust.
In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated AI solution to solve them. Pharma IT’s innovative IDMP Gap Analysis Tool offers a powerful, interactive solution for identifying and closing compliance gaps in their product data.
The Challenge of Data Synchronization and IDMP Compliance
The IDMP standard is a global framework, governed by the International Organization for Standardization (ISO) which aims to improve the transparency, accuracy, and safety of medicinal product data across the entire product lifecycle.
For pharmaceutical companies, the transition from xEVMPD to PMS introduces several new layers of complexity to IDMP adherence, especially in managing data from multiple sources. Key data points such as drug traceability, pharmacovigilance information, and lifecycle data must be consistent between internal systems (e.g. RIM, Veeva, and Regulatory Submissions systems) and public health platforms (e.g. databases managed by the European Medicines Agency (EMA) such as EMA’s PLM portal and EMA SPOR management services.
Discrepancies between internal data, and public health pages can result in severe regulatory consequences such as fines, legal actions, or even the withdrawal of marketing authorizations
Inaccurate or outdated information on public health pages like those of the FDA, EMA, or ANSM can also erode public trust by undermining the credibility of a company and its products.
However, the manual effort required to keep public health information synchronized with internal systems is a significant concern. This manual process is not only time-consuming but also prone to human error, leading to further potential data mismatches.
IDMP Gap Analysis Tool
To overcome these challenges, Pharma IT has developed an automated AI-powered IDMP Gap Analysis Tool, which provides an interactive approach to identifying and addressing compliance gaps:
- Interactive Data Mapping and Validation: One of the core strengths of the IDMP Gap Analysis Tool is its ability to map all relevant data (including inputs from internal systems like Regulatory Operations, Supply Chain, and RIM Systems) into the ISO IDMP data model. This feature allows users to interactively view and validate their data against the latest regulatory requirements, ensuring that all medicinal product data is accurately reflected in the PMS.
- Real-Time Insights: The IDMP Gap Analysis Tool extracts and analyses data from both internal systems and public health pages in real-time, including those managed by the EMA. You’ll always have the most up to date view of your data.
- Operational Efficiency: The tool reduces the manual workload on compliance teams by automating the synchronization of data across multiple sources, including legacy systems and newly developed platforms. This automation minimizes the risk of human error and allows compliance teams to focus on more strategic initiatives rather than getting bogged down in manual data reconciliation tasks.
- Customized Feedback for Standardization: The tool provides tailored recommendations based on specific gaps identified in the IDMP compliance process. This customization is crucial for reducing inconsistencies and errors in medicinal data, thereby accelerating time-to-market and enhancing efficiency.
- Transparency and Engagement Pharmacovigilance: The interactive nature of the IDMP Gap Analysis Tool fosters transparency and active engagement within compliance teams. By presenting data in an accessible format, the tool helps teams understand the scope and impact of data gaps, particularly those affecting pharmacovigilance.
- Alignment to EMA’s Roadmap (see Figure 1): As EMA continues to roll out its roadmap for transitioning to PMS, including the migration of SIAMED and XEVMPD data, the IDMP Gap Analysis Tool remains agile and adaptable. It integrates new updates and guidelines into its analytical framework, providing companies with a future-proof solution that evolves alongside regulatory changes.
Figure 1: The EMA’s Roadmap for the transition to PMS, including the mighration of SIAMED and XEVMPD data. Source: European Medicines Agency
Automate data synchronization, close compliance gaps, and stay ahead of evolving regulatory standards
The transition from xEVMPD to PMS represents a major regulatory challenge for the pharmaceutical industry, but it also presents an opportunity to enhance data accuracy, operational efficiency, and public trust.
With this powerful tool, pharmaceutical companies can navigate the complexities of PMS migration with confidence, ensuring compliance, trust, and long-term success in an increasingly regulated market.
Pharma IT’s IDMP Gap Analysis Tool uses real-time, interactive insights to empower your compliance team to pinpoint and close gaps in product data.
Contact us today to schedule a demo to see firsthand how our tool can help you stay ahead of regulatory changes, reduce risk, and optimize your compliance strategy.
About the author
Daniel Isaac Kemajou Njamen is a Consultant at Pharma IT and a passion-driven software developer with a master’s degree in Mechatronics Engineering, where he profiled in Software Development. Daniel has performed the role of Software Developer within different industries, including the Medical Device Industry, where he developed code for Hearing Instrument features implementation and defect mitigation. He is proficient in C, C++, and Python programming languages and has hands-on experience with Agile Processes.
