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PIM – pipe dream or reality?

PIM – pipe dream or reality?Labeling and regulatory affairs experts as well as representative from technology companies attended the two-day ExpertForum on Labelling, SmPC & PIM [PDF link] in rainy Munich. They all came to learn more about PIM (Product Information Management) and how it will be implemented and will affect their business. PIM has been talked about for almost 10 years now but no one seemed sure it would actually be implemented.

Despite some earlier questions, it is clear PIM is here to stay, and the EMA is firmly standing by its recommendation that PIM will need to be used for all submissions within the Centralised Procedure. Sure, everyone agrees that the timelines have slipped mostly due to implementation and performance challenges but by 2011 PIM will be prevalent for handling the labeling for new drug applications in the EMA.

What are the advantages of PIM? It provides structured XML format for labeling content ensuring that documents are compliant with the QRD all of the time – with the current process, it is estimated that over 42% of the time spent on submissions in spent fixing formatting issues. Additionally, PIM encourages reuse of content, making submissions more consistent and compliant.

The challenges that remain lie mainly in the technology, the authoring tool (Light Authoring Tool, LAT) that is currently provided by EMA for PIM does not provide the functionality nor the flexibility that the users need, the PRS (PIM Review System) in its current version is not scalable, its performance is lackluster and its intended users (National Competent Authority, NCA) are questioning its usability. Last but not least migration of existing product documentation will require some planning and some time.

But the tide is definitely turning, the PRS is being revamped and its new version (6.0) is expected to be released by the end of Q3. Technology suppliers are coming to the rescue by providing authoring and editing platforms as well as integrating with tools to streamline the translation process. With seven products currently going through PIM within the Centralised procedures and major pharmaceutical companies willing to invest the time and resources to work with PIM, it is safe to say that PIM is becoming a reality!

For more information about PIM, please visit the EMA web site.

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.


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