The presentation “Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?” was given by Deborah Cooper, Vice President Consulting at GENPACT Pharmalink, at LORENZ userBridge.15 in Vienna, Austria.
In her presentation, Deborah Cooper discussed the impact of the ISO IDMP Implementation Roadmap on RIM strategies and presented the GENPACT IDMP readiness assessment for customers.
The ISO IDMP Standard and Iterative Implementation Roadmap
Based on EU Commission Implementing Regulation No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616). This should simplify the exchange of information between regulatory authorities, enhancing the interoperability of systems at EU level and internationally. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards.
This phased implementation was originally planned to commence in July 2016 with the release of terminologies, or so-called controlled vocabularies, and organization identifiers.
Information update: Currently the SPOR Task force (formerly known as EMA ISO IDMP Task Force) is working primarily on the RMS and OMS, which means Referentials and Organizations, for which User Acceptance Tests are scheduled for the autumn of 2016. Following that, it is now expected that the EMA ISO IDMP implementation guidelines will be issued by the end of Q1 2017. This presents a one-year delay in the start of iteration 1, vs. the original timing.
Once implemented, EMA will replace its current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 common product model.
In her presentation Deborah pointed out that this phased approach has its benefits, but also presents some challenges: The benefits include more achievable timelines, increased time to gather and normalize data, and the opportunity to engage with stakeholders in a more business focused approach. With the phased approach, the implementation can be better aligned with existing company RIM implementation roadmaps, while the introduction of the EMA SPOR model supports company internal Master Data Management strategies.
The challenges include the increased complexity of the overall program, a wider focus, lower annual budget and less dedicated resources. This phased approach imposes an increased data exchange with the agency (gateway) – iterative and additive (non-synonymous versions). In addition, a staging repository will be required for sub-set data. The iterative delivery of the modular IDMP solution will require increased validation and migration effort, an increased number of revisions, rollouts and SOP trainings. Substantial stakeholder management engagement is required as well.
Impact on RIM Systems Covering Processes for IDMP Compliance
Almost all phases of a medicinal product life cycle starting with concepts and feasibility studies, continuing with development, product launch readiness and product launch up to the discontinuation of a product, are covered by RIM systems supporting the related processes in the RIM workflow:
- Regulatory Intelligence and Strategy
- Registration Planning and Tracking
- Labeling and Maintenance
- Dossier Preparation and Publishing
- Submission Management and Maintenance
- Health Authority Communication and Reporting
- Quality Oversight and CAPA Management
- Batch Release
- Change Management and Control
- Analytics, Commercialization, Packaging and Artwork
Aligned with the introduction of IDMP, the IDMP and Master Data Management process is also introduced to take care of the related data elements.
Deborah Cooper explained that IDMP requires a new generation of RIM systems. While the first-generation RIM systems only supported local command and control and the delivery of XEVMPD data to the EMA, the RIM systems of the second generation have to be able to handle pharma products, packaged products, medicinal products, marketing authorizations, manufacturers, substances, strengths and clinical data on a regional basis for ISO compliance. In turn, RIM systems of the third generation will have to go beyond the regional approach and handle globally compliant master data. These new RIM systems require comprehensive internal data management, standardization and data governance, which exceed the boundaries of the traditional older generation systems.
Implementation Methodology for the Industry: IDMP Readiness Assessment and Roadmap
How can pharmaceutical companies now approach the new IDMP requirements and the impact on their RIM systems? Deborah proposed starting with an IDMP readiness assessment. The ISO IDMP standard defines the data models supporting the structuring of authorized, investigational and structured substance information. Four constituents have to be reviewed to determine the impact of ISO IDMP data on the company’s repository and RIM system(s):
- Data: What data exactly is required (mandatory/conditional/optional)? How difficult is it to find? What is the process for missing data? What is the data quality like? Can you leverage your current XEVMPD strategy? Should the data be transitioned manually or by electronic “ETL” (extraction, transformation and loading)?
- Systems: Which systems contain the data? How much transformation of the data source is required? What is the most pragmatic solution for the ISO IDMP system? What impact does this have on the overall RIMS roadmap?
- Processes: What is the impact on the current process? What can be done to avoid rework? How should you define the maintenance process? What impact will this have on new regional adoption of ISO IDMP?
- People Change Management: What cross-functional engagement will be required?
For the assessment Deborah proposed the following process steps:
- Identify sample products from the portfolio
- Identify possible sources of information
- If found, identify the golden sources of information
- Identify the gap between the available information and the ISO IDMP compliance requirements
- Build a model for compliance with the sample product information
- Evaluate solution options to add the missing information (manual, automated, hybrid)
- Estimate possible effort requirements for complying the sample products
- Do the forecast of effort requirements for the complete product portfolio
If the possible sources of information cannot be identified in step 2, the percentage of such information should be determined and considered in the final portfolio analysis.
Executing this assessment, customers may find the following results, based on GENPACTs experience: XEVMPD data elements make up approximately 33% of the new ISO IDMP Standard. Between 80-94% of information required for ISO IDMP can be derived from systems and documents or from validated external sources. 6% of fields are still not confirmed by European Medicines Agency, 19.2% of fields are associated with Medical Devices.
As shown in the figure above, GENPACT has developed a complete ISO IDMP roadmap for customers, starting with the readiness assessment, continuing with a transition phase followed by the manual and/or automated collection of data phase and finally ending with the maintenance phase.
So coming back to the initial question: What comes first, RIM or IDMP? My answer would be: They go hand in hand, but from the very beginning data quality is crucial, so this is what really comes first! No matter which timeline and which approach companies take: high quality medicinal product data will always help!
Written by Ernst Lange, Global Key Account Manager at LORENZ Life Sciences Group.