DQSA, FMD, Serialisation – Even more need for a Master Data Management (MDM) strategy, with a GS1 Compliant PIM at the heart

It’s a wonder we ever meet in person. With the explosion in digital technology we could just gather on Skype. The ease and convenience of online meetings oftentimes overshadows and underrates the value of actually getting together. This was amply demonstrated at the offices of Lifestar who recently hosted a meeting for the QP Forum. The Forum, organised by Alex Hall of QPQuandary, is a networking and learning group for QPs in the UK. QPs are the people ultimately responsible for the quality and integrity of pharmaceuticals; they are the “Qualified Persons” who certify that every batch of medicinal product manufactured has been made as it should and that the medicines we take are as safe as they can be.

When you get a group like this together you expect the usual “Where are you from?” “How was your journey?” kind of ice-breaker session. What you don’t expect is how rapidly such a diverse group of professionals get to the heart of the matter. Even before the formal presentations had begun we were in deep discussions of exactly how you trace human derived cell therapies, especially when you’re using them in the context of clinical trials.  Not your usual small talk…

The meeting consisted of Hall providing her characteristically comprehensive, informed and concise fly through of the European Union’s Falsified Medicines Directive (FMD), the main subject of the evening, before Chris Doyle of Genshone got onto the main topic of serialisation.  To point out the difficulties likely to be faced by pharma companies in the UK in meeting the demands of the EU FMD, Doyle used LANSA’s experience in delivering a Product Information Management (PIM) solution for the Food & Drug Administration’s (FDA) Unique Device Identification mandate and his knowledge of the USA’s Drug Quality and Security Act (DQSA).

It was noted that the central difficulty faced in the USA has been the volume of data that needs to pass between trading partners in the medical supply chain in order to achieve the level of track and trace that the US authorities will require after the deferred DQSA deadline of 1st May 2015. The fact that the central purpose of the FMD is to achieve verification at the point of dispensing means that the data management challenge pharma companies will face across Europe will be yet more exacting; a challenge that cannot be delayed any longer.

LANSA had been asked to sponsor the meeting because of our experience in master data management, specifically in regard to our PIM solution’s ability to publish pharmaceuticals’ item attribute details to the FDA’s Global Unique Device Identification Database (GUDID). Our use of the Global Data Synchronization Network (GDSN) to make these GUDID submissions means we have great insight into the benefits and pitfalls of using the FDA’s platform for regulatory compliance, and our experience will prove invaluable to this audience in meeting the demands of the EU FMD.

The opportunity to exchange views on these big data management challenges with an audience as diverse as this, with attendance from NHS, GSK, Tesco, Hospira, Nelson’s and many others is invaluable.  Given the choice between this forum with canapes and white wine and Skype on a rainiy Thursday night – I’d choose canapes every time.

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