Most life sciences products continue to evolve long after approved formulations have entered the market, and all of these changes must be carefully tracked, managed and reported to maintain registrations, manufacturing transparency and patient safety.
Although the value of developing more data-driven processes is now widely recognized, many life sciences organizations today still routinely create critical documents and product labeling from scratch. This involves capturing and applying the same information repeatedly, yet often in different formats and using inconsistent terminology.
Find out how life sciences manufacturers and marketing authorization holders can reduce the maintenance burden and mitigate the risk of registration delays.
With the publication of EMA’s IDMP/SPOR implementation guide (V2), the transition of the ISO IDMP product data standard can be transformational.