[DIA Europe 2024] Reimagining Labelling E2E Process: EU Centralised Procedure

Preparing labelling content for submission and authorisation today is still a very convoluted manual process, which involves lots of transcription and adaptation to meet regulatory requirements. Furthermore, downstream processes such as translations, artwork creation and compendium publishing are equally dependent on manual steps, not to mention the upstream core labelling conformance checking. Obviously, basic MS Word (copy/paste) is still the number one tool in a Regulatory Operations professional’s toolkit and productivity has reached its limits. Cost of poor quality is high, and mitigating risks of labelling mistakes becomes increasingly difficult. Meanwhile, digital technologies have advanced, and they are ready to transform this space. In this session, we reimagine the labelling end-to-end process thanks to digital technologies, with a focus on the EU centralized procedure, where 96% of marketing authorisations are based on languages other than English. We discuss how modern content and notably translation technologies can support the challenge of managing all EU/EEA languages, with a focus on achieving and maintaining the highest quality and regulatory compliance whilst improving productivity. Industry experience and lessons learnt are also shared. Learning Objectives: 1) Recognize the typical challenges with regard to end-to-end EU centralised procedure for labelling, from authoring to translation and update cycles; 2) Assess the importance of adopting emerging content and language processing innovations, in order to modernize regulatory practice; 3) Gain insight into the experiences, lessons learnt and key success factors for a sustainable digital transformation - meeting both the regulators’ policy standards for patient safety and company’s (global) objectives. For a Global Pharma organisation, EU CP labelling is just one of the many Global Labelling challenges.