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At recent the BETHEEXPERT 2017 event in Budapest, we asked Romuald Braun what pharma should be focusing on with regard to its labeling activities.
Romuald Braun: I believe that the most immediate concern in labeling is with the consistency of the available information. We get a lot of feedback from our clients, and also from the market that they have labeling documents in different countries but actually they are not sure about the content, especially the data in these documents, and whether each version is really corresponding with each other. So even if they are the same but they are not corresponding with each other - because it is not only about data but also about translations - how do you make the different languages, the different versions of documents consistent with each other?
Historically, the majority of the market has been focused on semantic technology, using these tools to re-use elements of living documents to essentially make them more consistent with each other.
However, semantic technology is siloed, which means you put yet another system in place that requires integration with other systems, adding another layer of complexity.
A labeling document is a living document, an expression of data, so my recommendation would be to start with cleaning the data to get it in sufficient order to make it consistent. From there this data can then be used with labeling documents. You could potentially fully automate the creation of labeling documents sourced by the master data of products, but you could also go step by step because that’s not just a technological issue but also an issue of how you plan and manage the organizational change. When using automation then the processes will change dramatically if you switch to that from the traditional approaches, so step by step is a way of managing all this effectively.
Well, it’s very simple, because once you have all of your events, related to the product data it’s very easy to reflect them in complex environments in all their required labeling documents. But if you do it manually in the traditional way, there is a very high risk if you miss one or two or three countries or even some products some people are not aware of the side effects and then you have medication errors.
Within labeling, because of the specific languages and nuances in each country, you will always have some need for local representation in the workforce. With the rise of globalization, the global versus local debate comes up a lot and I believe each organization must approach this according to their own needs and choose what best suits their business.
There are certain things which make absolute sense to do on a global or central level, and there are other things which makes sense to do on the local level. So I believe there will always be a need for some local representation, but obviously organizations must be wary that the local workers have the skills and experience to not let the quality suffer.