DIA Europe 2024

With many significant technology and business investments going on in parallel towards transforming product lifecycle management in Europe, it can sometimes be challenging to understand where this will lead us. What possibilities will be unlocked for regulators and industry but also crucially for citizens and healthcare professionals, who are the centre of this transformation. This session will provide an insight into the developments underway in building fundamental enabling technologies for interoperability and will explore from a European, national and industry perspective how they will lead us towards a more integrated way of working in the future – all with the goal of ensuring safe and effective medicines and reach patients as efficiently as possible. The session will offer a user/patient perspective on practical use cases enabled by the transition to ePI, and the industry perspectives on data-driven submissions and use cases for the health of the patient in Europe and everywhere in the world. Learning Objectives: • Gain an insight into the approach being taken to transform product lifecycle management technology in the European regulatory space and how this approach intends to unlock the potential for more efficient and effective medicines regulation and healthcare outcomes. • Hear how a collaborative and standards-based approach to this transformation will be leveraged by regulators to improve business operations and deliver healthcare information towards patients and citizens, with the example of ePI and FHIR data exchange. • Understand the importance of this digital transformation from an industry perspective, aspirations for a more data-driven future and how a joined-up approach will support access to safe and effective medicines for patients and veterinarians and lead towards global alignment.