The Head of Medicinal Agencies (HMA) eSubmission Roadmap (November 2014) already highlighted that from 2016 all new veterinary Marketing Authorisation Application’s (MAA’s) for the Decentralised and Centralised Procedure (DCP and CP respectively) have to be in VNeeS format. Furthermore, from 2017 all veterinary submissions via the EU procedures need to be compliant with VNeeS. The recently released guideline prepared by the Veterinary Harmonisation Group (March 2015) provides some more details with regards to formats, file folder structure and naming conventions, coming into effect October 2015 already.
This highlights a number of challenges for the pharmaceutical industry providing veterinary medicines. Read More
How can Samarind help you achieve what I have been talking about in my previous two posts – Is it time to turn your reporting structure ‘upside down’ and the importance of a single place of truth – that will help you escape the net of complexity that you get from having multiple, silo-ed systems?
By Dr Olaf Schoepke, Director of Strategic Development, Samarind RMS
Last time I blogged here, we spoke about how important drug information can get spread around multiple systems. We believe that clients are finding this more and more an inefficient way to work, which is why we are starting to recommend that instead they move to ‘flip’ data – keeping it on one system that can then be the source for when it needs to be driven to where it needs to be at the right time in the whole massive research-trials-approval-pharmacovigilance-reporting process.
If you want to know why, think about those big systems, the five or six trails or submissions structures which you are probably currently working with. So, when you think about these silos, for example, if you have to use four or five silos for four or five systems, how do you combine these? At the moment, you take one system and you integrate it with the others. Say you currently have a kind of base, a foundation, which is fine: now you can link system 1 to system 2 and then system 2 to system 3 and back to system 1 and so on.