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Archive for category: XEVMPD

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Underwhelmed by the draft ISO IDMP implementation guides

I’ve been re-reading the ISO IDMP implementation guides. These were distributed for comments towards the end of last year, and we expect revised documents for the main two (covering ISO 11615 – medicinal products and ISO 11616 – pharmaceutical products) soon.

Although I’m used to reading long technical documents – the XEVMPD and UDI ones for example – I hadn’t read an ISO implementation guide before, so I didn’t really know what to expect. I found the ISO IDMP standards themselves to be very good and I think I assumed that these would be of similar quality and usefulness. Unfortunately, in their draft state at least, I must admit I was disappointed.
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EMA’s QC process, the 3rd ACK and other XEVMPD frustrations

I have been following the progress of the EMA’s XEVMPD QC process and the developments around the dreaded ‘3rd Ack’ for months now, and I’ve had discussions with many people about the challenges this causes for MA Holders. The key issue is that as part of the QC process, the EMA contractors are actually changing any data that they decide is incorrect, without telling the owners of the data exactly what they have changed.

There are a number of problems with this: Read More

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XEVMPD – how do we do it – part 3

Following the publication of the latest EMA guidance – which was updated again on 5th March – my previous blogs examined the five new fields that are required by the EMA and the XEVMPD data quality and controlled vocabularies. Here in the final blog of this set I’m covering local language SmPCs and timelines, and offering my opinion on the situation and how best to achieve compliance.

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