Using IDMP Preparations to Improve Data Management at Veeva R&D and Quality Summit Connect
The release of the EU Identification of Medicinal Products (IDMP) Implementation Guide version 2.0 triggered the countdown to a mandatory submission deadline. With the clock now ticking, biopharma companies must prioritize IDMP readiness programs.
AstraZeneca, Bristol Myers Squibb, and Takeda discussed their IDMP preparations in a panel session at the Veeva R&D and Quality Summit Connect. The panelists provided practical guidance on data and organizational readiness. They also described how they’re using IDMP compliance as an opportunity to enhance data governance, data quality, and cross-functional engagement.
IDMP as a Catalyst to Strengthen Data Governance
Emma Luke, Regulatory Data Governance and Quality Lead, shared lessons learned from AstraZeneca’s five-year journey towards IDMP readiness. xEVMPD and now IDMP have driven AstraZeneca to manage data holistically. A central data governance organization provides oversight across R&D with key roles focused on data quality and policy. A new regulatory data office adds another level of accountability and granularity. Emma advised biopharma firms to focus on data, not just the deliverable. “It’s no longer just about getting the submission out the door,” she said. “It’s about getting the right data at the right time during the process and being able to move it around the enterprise.”
Setting the Foundation with Data Readiness
Patrick Middag, IT Business Partner Global Regulatory Sciences, detailed the prudent, phased approach Bristol Myers Squibb has taken to prepare for IDMP. After evaluating their data, processes, and systems, the company launched several foundational workstreams, including data remediation, data compliance, and data governance. These data readiness activities will help “get our house in order” before IDMP mandatory compliance. Patrick encouraged regulatory teams to think broadly and cross-functionally during IDMP preparations. “It’s very clear through our change management efforts that IDMP will become everyone’s responsibility,” he stated. “There’s a lot of education going on to prepare peoples’ mindsets.”
Organizational Readiness Requires Cross-Functional Collaboration
Marguerite Tyler-McWilliams, Takeda’s Associate Director of Regulatory Informatics and Analytics, reiterated the value of cross-functional partnerships when readying the business for IDMP. Takeda’s regulatory team is reaching out to manufacturing and supply chain to make sure they understand the IDMP process and the data elements for which they’re responsible. “Breaking down silos is really important,” Marguerite stressed. Regulatory’s awareness campaign ensures “that we’re all working towards the same goal and have exchangeable data without a second outreach.” Takeda is also applying data governance principles, like controlled vocabularies, to improve interdepartmental data sharing.
Thanks to the panelists for sharing their strategies for IDMP readiness. And a special thank you to Patrick Middag for representing the industry’s interests as a member of the EU IDMP/SPOR Task Force. To watch the full session recording, Veeva R&D and Quality Summit Connect hub.