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Archive for category: General Regulatory Issues


Regulatory Information Management (RIM) and VNeeS for Veterinary

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


XEVMPD – How do we do it? – part 1

Most of you will have seen the latest EMA guidance by now (all 484 pages of it) – and read the much more digestible 4-page article by Andrew Marr in Scrip. Andrew’s article is an excellent summary of what’s required, and I thought it might be useful to reflect on the points he raises and translate his ‘what you need to do’ into a ‘how to do it’.

I’ve divided the points up into a discussion about the new fields, how to improve the quality of your data, the impact of the tidying up the controlled vocabularies, local language SmPCs (summaries of product characteristics) and timelines. I’ll talk about the new fields this time, and the rest in the next couple of blogs.

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Medicinal Product Line Outsourcing: an Option Worth Considering? – Part I

The Opportunity

Change creates opportunity, so they say. Well, here’s one change that might benefit – if handled right – the medicine originator, the service provider and, most importantly, the patient by just moving the responsibilities of an entire medicinal product line into different hands.

What opportunity am I talking about – as outsourcing itself is neither new nor terribly exciting? Read More


Will We See Big Pharma Coming ‘Home’ sooner than we expected?

Today, I’d like to talk about some of the bigger trends affecting the pharmaceutical sector. Without a doubt, there has been a huge amount of change that affects every part of the sector, from the main players in it to the smallest – change which we all need to start working out how to cope with, I think you will agree.

Take downsizing. I don’t need to remind you of the way some of the biggest corporations in this sector have pulled a lot of resources out of Europe, moving and re-aligning, opening new facilities in Asia. We’ve seen this happen across the globe, actually, so not just in Europe.

What’s driving this? The reason is because drug development – and clinical trials in particular – is cheaper to run in those countries. But when it happens, it’s unquestionably a huge shock to the present host country and the whole supply chain around that old business.

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The Importance of a ‘Single Place of Truth’

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.

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