Solutions Circle: 5 Ways that an RA Department Will be Impacted by IDMP Data Standards

This presentation will discuss how to assess and manage the complex impact from EMA's IDMP/SPOR program across an entire organization. The session will address ways to create an overview and evaluation of the impact across several business areas and how to create awareness within the organization about this impact. It will be discussed how to take into consideration the interdependencies between the various initiatives and how to orchestrate the preparations. The presentation will discuss strategies and methodologies for bringing systems and processes in place for the gradual adoption of the relevant data standards, whose scope and timelines are subject to changes and delays. The presentation will also provide benchmarking of where the largest challenges – as well as opportunities - lie for the pharma industry and the regulators. It will also provide an insight into the major technological challenges as well as the data governance and monitoring that are necessary to introduce across the organization for maintaining alignment and data quality across systems and processes that interface with EMA’s SPOR systems. The presentation will deliver concrete, hands-on experiences from the implementation of EMA’s SPOR program that are applicable and illustrative to a wider audience with interest in the impact from EMA’s data standardization initiative.