Data data data…
It seems that this new decade will become the decade of data.
Technology and healthcare sectors are evolving and therefore regulations must follow the same path. HMA and EMA joint Big Data Taskforce (BDTF) have released a document analysing the current situation and establishing the top-ten recommendations to focus on.
The first recommendation is to develop DARWIN (a Data Analysis and Real World Interrogation Network). An EU data platform that supports better decision-making on medicines.
One of the strategic objectives is to improve data quality and for that HMA and EMA BDTF encourage and promote the use of ISO IDMP for regulatory submissions.
ISO IDMP is intended to be implemented during the next years, but before this, there is a lot work to do to improve data quality knowledge and create new processes based on data.
Asphalion is always willing to help companies to establish their new processes to improve their performance.