Session (CTI)

ISSUE: Patient Experience Data (PED) are considered in the EU as data that directly reflect the experience of a patient or carer, without input or interpretation by a healthcare professional, third party, or (AI-based) device. Recent years have seen initiatives by regulators internationally to encourage the collection and use of PED in medicine development and throughout the whole lifecycle of medicines, to not only meet the requirements for quality, safety and efficacy, but also to incorporate patients’ and carers’ broader perspectives . This can allow a more informed assessment and decision-making by medicine regulators, health technology assessment (HTA) bodies and healthcare professionals and patients themselves. However, the current lack of up-to-date and consolidated guidance on PED creates several uncertainties, both for stakeholders collecting or generating these data to support health related claims as well as for those on the receiving end of these data in their assessment for decision making. EMA is developing a reflection paper to describe general principles on the use of PED across the lifecycle of medicinal products to encourage systematic consideration of PED in medicines development programs and regulatory submissions. This session will discuss the key aspects of the EMA’s upcoming reflection paper on PED , preliminary perspectives from different stakeholders and possible next steps to further strengthen the use of PED in regulatory and access decision making. OVERVIEW: To set the scene, an overview of the key aspects of the EMA’s reflection paper on PED will be provided (15 min), followed by a short presentation on ongoing EMA’s work to describe how PED is being incorporated in applications for marketing authorisation and extension of indication (15 min). A panel discussion and a Q&A will follow, to reflect different perspectives (see above list of panellists) and propose some possible next steps.