About this event
The life sciences industry is on the cusp of a data revolution, with IDMP at its core. However, many organisations are grappling with the challenges of integrating SPOR services, aligning with FAIR principles, and leveraging ontologies effectively. The result? Inefficiencies, compliance risks, and missed opportunities for innovation.
Join us for an insightful webinar on "Ontology-Driven Integration: IDMP Efforts with a FAIR Outcome," where we'll unlock the secrets to seamless data integration and IDMP compliance.
Register to see Michiel Stam, Management Consultant and Senior Regulatory Expert, MAIN5, and Haidi Koçi, Client Delivery Analyst, Generis, provide invaluable insights into:
· The pivotal role of SPOR services within the EMA’s master data management strategy
· How integrating these services with key applications is revolutionising data quality and availability, significantly reducing manual labour and rework
· The power of IDMP ontology (IDMP-O) and knowledge graphs for achieving true data interoperability
· Aligning master data management with FAIR principles to ensure your data is Findable, Accessible, Interoperable, and Reusable
This webinar will provide a comprehensive understanding of how ontology-driven methods can lead to a FAIR outcome in IDMP data integration, setting a new standard for data management in the industry.
Secure your spot today and be part of the conversation that shapes the future of data interoperability.
Hosted by
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Team member
Haidi Koci Client Delivery Analyst @ GenerisT
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Guest speaker
Michiel Stam Management Consultant and Senior Regulatory Expert @ MAIN5G
I am a Management Consultant and Senior Regulatory Expert at MAIN5 with 15 years of experience in Regulatory Information Management (RIM) and IDMP. In my role I offer strategic direction and subject matter expertise to implement effective Regulatory Information Management (RIM) solutions. Beyond compliance, my focus lies on unlocking the true value of an organization's data through initiatives like XEVMPD, IDMP, and SPOR. By aligning people, cross-functional processes, and tools, I ensure efficient and sustainable data quality. Additionally, I have extensive experience with eCTD and other electronic submission formats. Throughout my career, I have successfully led various submission and regulatory information management projects for Pharma and Biotech companies. This includes the preparation and submission of initial MAA's and post-authorization maintenance for agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA), as well as other regions.
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Guest speaker
Katharina Mayer Principal Consultant @ MAIN5G
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Team member
Karolina Rogowska Head of Marketing @ GenerisT
