For several companies, the announcement of the EMA that the DADI project will be the 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 cannot 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 implementation of ISO-IDMP brings to the life science industry remain 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 the internal improvements in data quality and processes, 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.
Join us to hear from the perspective of our Identification of Medicinal Products (IDMP) subject matter expert, Wim Cypers.
In this 3 part series, we will be focusing on three important aspects of an effective ISO-IDMP implementation within your organization.