Our IDMP Consultant Adnan Jamil attended the 2nd Annual IDMP Update Forum in Philadelphia, together with Christian Buckley (Astellas). They participated in the expert panel discussion and provided attendees with their experiences from the Astellas IDMP program. Several topics were discussed within the panel discussion:
Building Cross-Functional Support for IDMP
Since IDMP has a broad impact on the business, requiring data to be collected from multiple organizational domains (regulatory affairs, clinical, manufacturing, etc.) The panel members discussed how the cross-functional support for IDMP was built at their companies to ensure an ongoing collaboration and support from the different areas. Additionally, the drivers for changing the internal processes (e.g. data management, labeling, etc.) were shared.
Solution Patterns and Organizational Applicability
As there are numerous solution options available, each organization needs to assess the most fit choice. Choosing a solution was one of the more prevalent discussion topics at the conference. Chris and Adnan shared the road Astellas had taken towards the final IT architecture, the solutions that were put in place (controlled vocabularies management tool, structured authoring tool, business glossary and an IDMP application), adaptations to existing systems (e.g. RIMS) as well as the interaction between these systems.
Short and Long Term Strategies
As IDMP keeps evolving (e.g. EMA’s iterative approach, implementation by other regions), the strategies adopted for IDMP programs could include a combination of tactical and long term steps. This way, the programs could start delivering tangible results and potential improvements on a short(er) term. The approaches taken by the different companies were discussed. Astellas’ early adopter approach and the resulting benefits were shared with the attendees.
Data Governance and Ownership
IDMP has a significant larger scope, compared to xEVMPD (e.g. data fields, investigational medicinal products). With this change, a significant focus on the data governance within organizations is expected. The panel members described the maturity of data governance within their organization, as well as a description what this data governance consist of.
Would you like to know more about these topics, and about how Iperion can support you in making the right decisions for your company? Contact us!