DIA EUROPE 2021

The paradigm shift from document based processes to (semi)-structured date for electronic product information, will create new opportunities for medicines information dissemination withininhealth systems. Regulatory efficiencies and operational excellence will also be achieved for the benefit of Regulators and Industry via a coherent and consistent implementation of ePI across Europe with significant consequential value for patients and healthcare providers. To achieve this, a standard should be adopted in the creation, submission and review process. As Regulatory data becomes the primary communication form between marketing authorisation holders and Health Authorities, its accuracy, completeness and reliability is more important than ever. Post-approval ePI also presents opportunities for leveraging advances in AI and natural language processing, which have the potential to enable intelligent labelling solutions.Therefore, this session will explore the requirements and skills sets needed for rolling out and implementing ePI within MAHs and Health Authorities. The session will also demonstrate how AI can potentially play a role in future ePI based operations.