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 3 of 3: Cross Department Benefits.
In this last session we will be focusing on some specific use cases where IDMP can play a role. We will look at possible integration points with safety, manufacturing and clinical. How can the integration be achieved, what elements are needed and how can you ensure the approach is extendable.