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Author Archive for: olaf


eCTD EU M1 v3.0 – A somewhat hasty implementation?

The EMA just released a new version 6.1 of the eCTD technical validation criteria, having corrected the MD5 checksums for two of the regional files. The good news is that the MD5 checksum did in fact exactly what it was supposed to do, i.e. protecting file integrity. Because of additions such as “EDQM” in eu-regional.xsl, eu-regional.dtd and eu-envelope.mod (eSubmission EU Module 1), the MD5 checksum changed. Although the checksum for eu-regional.dtd was altered in the eCTD validation criteria version 6.0, checksums for the other two seem to have been missed. This has now been corrected with version 6.1.

However, were these the only changes undertaken? Well, not quite. Read More


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


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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