For several companies, the announcement of the EMA that the DADI project will be main focus for regulatory data submissions has meant that they needed to revisit/realign their IDMP implementation projects once again. But is/was this really needed and if so how can this be avoided going forward?
It can indeed not be denied that the approach needed to achieve compliance is shifting continuously but at the same time it is important to realize that the underlying ISO-IDMP structure remains the same. The benefits that an implementation of ISO-IDMP bring to the life science industry remains the same. As such it is important that your implementation strategy is not only focused around achieving compliance. But that it also keeps in mind internal improvements in data quality and process’s the implementation of the ISO-IDMP standard can bring. Achieving compliance should be an important part of your strategy but your strategy should not be controlled by compliance only.
Webinar Series Part 2 of 3: Process Optimization.
In this session we will be looking at both external (compliance) and internal facing processes’. How do you best address the phased DADI approach and how do you align this with the need to keep the xEVMPD submissions going in parallel. What is needed internally to ensure that data is shared within your organization at the appropriate time and how do you build processes’ which ensure data is not only shared but also stays in sync over time.