DIA EUROPE 2021

Involvement of patients is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. Patients have been increasingly involved in European Medicines Agency (EMA) procedures and Committees for many years and the value of their input is broadly recognized by Industry as well as the EMA. However, there is room for further development and an opportunity to evolve and incorporate a more systematic approach to ensuring the patient’s voice is not only heard but consistently actioned in regulatory procedures and decision making across the medicines value chain, from development, through evaluation to deployment. The session will bring together patients, academia, industry, regulators, HTA bodies and payers to discuss the journey of making patient engagement part of standard processes. Participants will gain insights about existing tools and best practice and discuss: - Qualitative and quantitative approaches to provide more systematic patient preference and patient-relevant endpoints into benefit risk decision-making process building on existing IMI programmes and other initiatives. - Deployment of existing tools and approaches including metrics to determine shared value of patient engagement