The EMA is getting ready to release its tool for creating EVMPD records online. The intention is to have that ready by the end of January and while that seems helpful, I have my doubts. The problem is that it’s an enormous management task to repeatedly enter the same information each time you create a new record. I don’t know yet if there’s any simple way of managing the information over time using their tool, or if it’s only there to create the record to be sent. What they’d have to create is really your information management system, which I don’t believe is the EMA’s intent.
From my experience with similar tools, they’re not always very friendly to use. For example, the tools the FDA has created for SPL, drug listings, and establishment registrations and the EMA’s Light Authoring Tool for PIM weren’t necessarily the best ways to manage information.
To find more information please click here : CSC: EVMPD-Guidance Sorely Lacking as Mandate Approaches - By: Joel Finkle, Senior Strategist, CSC Life Sciences
I dont necesarily agree. From my side I think it would be completely possible, that EMA would jump on what they developed for PIM, tweak as needs be and roll that out as their tool. The PIM tool, while it was somewhat clunky it was able to capture metadata and that could work in this case.
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