If your answer to any of these questions is yes then you clearly suffer from Serialisation Fatigue (also known as Traceability Tiredness), that “nervous exhaustion which comes from spending a lot of time and attention on understanding what the globally established and emerging traceability requirements mean for you as a pharma company – originator, generics company, contract manufacturer or parallel trader – or, indeed, any other participant in the pharmaceutical supply chain”.
As early adopters of serialisation, 3C Integrity own up to being as guilty as anyone of increasing this fatigue through sharing repeated messages about the challenges you may face, the importance of getting a clear understanding of what it means for you and most of all the urgency to get started before time is running out.
We recognise that our messages can be a contributory factor to traceability tiredness but we know how essential these messages are to serialisation success and how important it is to recognise the symptoms and not ignore them or the underlying condition.
Despite repeated delays in some key markets and frustrating lack of clarity in others, there is no denying that on top of the traceability compliance requirements that are already in force throughout the World, an overwhelming second wave is rushing towards the industry which you ignore at your peril.
Having been involved in this area for almost 10 years, 3C Integrity have a keen understanding of the size and complexity of the task ahead. We are not overstating the case if we stress that by delaying your implementation of serialisation you are putting significant parts of your sales – up to 80% – and therefore likely your whole business at risk.
So here are four tips from Dr. 3C to help you recognise and deal with Serialisation Fatigue.
Day-to-day activities can stop you focusing on serialisation and putting a plan of action together. Engaging stakeholders can also be a challenge and something you would rather put off. Try not to concentrate all your activities, engagement and planning in one burst. You are looking for a sustained approach to serialisation to keep you going until implementation and not burn out on route.
Research is rarely wasted and can always be useful. Mapping the wider landscape of serialisation such as systems, participants, compliance reporting will help you identify trouble spots early on. It could also help you pinpoint where you could improve your current processes as well.
A review of your current capabilities will help you understand where you need to invest but also where you can tailor implementation to your current (and future!) processes.
Meeting the requirements of the EU-FMD and other requirements might not necessarily mean what you think. Extending your knowledge of the subject is the best way to find the right messages on serialisation and inform your own implementation programme.
At 3C Integrity we regularly run innovative, vendor-independent training events that offer a unique and invaluable chance to ensure your programme is on the right course. We’ll be announcing details of our next serialisation training event shortly, we also provide in-house training events and consultancy for clients across the world contact events@excellishealth.eu for more information.
You can also see Ian Haynes at FlyPharma in Heathrow on the 10th September at 9.30. Meanwhile you can catch Christoph Krähenbühl at the Jahresforum Pharma Track and Trace in Berlin on the 14th September. Keep an eye on Twitter and LinkedIn for more details of our conference appearances.