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European Biopharmaceutical Review

Compliance Complexity in the Data Management Landscape

With regulatory complexity soaring, the momentum behind product data management transformation should be peaking. However, the evidence suggests that this is not the case and that life sciences companies may be investing uneconomically each time they digitise a process or update an existing IT system, because they are continuing to approach each project in isolation, instead of as part of a bigger vision. While, encouragingly, organisations now appear to recognise the need for a more holistic approach, in 2019, life sciences companies will need to focus attention on developing a vision for delivering this and mapping it to a hard strategy. If not, companies risk throwing good money after bad by enhancing existing information silos and will fail to make a dent in expanding regulatory compliance workload.

There is no question that regulatory compliance demands are growing more onerous. In addition to a growing emphasis on expanded product detail and high data quality, integrity, and consistency, the different regulatory bodies around the world retain their own particular focus on what needs to be delivered, and how. Between the transition to the ISO IDMP medicinal products database in EU markets, similar ambitions in the US, and more diverse information digitation initiatives in regions such as Asia, life sciences firms have their work cut out to ensure they have, and can easily find, all of the data they need, and combine and deliver this in an efficient and reliable way to the regulatory authorities.

Something Has to Give

For now, compliance and complexity go hand in hand. Between the diverse IT systems and particular processes employed by different functions across organisations, to the number of products and countries these are sold into and their respective regulatory expectations, there are thousands of elements, and millions of data points, that must be aligned to achieve marketing authorisations and keep products in the market. Furthermore, each change to a requirement or to a process can increase the complexity one hundred-fold.

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Romuald Braun is Vice President of Strategy for Life Sciences at AMPLEXOR. He holds a Master’s degree in drug regulatory affairs and an Engineers’ diploma in data technology. Romauld has spent the last 26 years working in compliance, document management, and content management-related roles in this industry, in client-based as well as consulting and project management roles.
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Romuald Braun
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