Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making
Event
Human
Research and development
Date
Location
Patients have valuable insights and perspectives from living with a condition and its treatment. This includes symptoms, natural history, quality of life, unmet needs, which outcomes are important and preferences for future treatments. Input from patients, as users of medicines, can inform medicine development, enhance regulatory decision making and result in more patient-relevant outcomes.
EMA’s Regulatory Science Strategy to 2025 recognises the need to identify optimal approaches for engaging patients in medicines development and benefit-risk assessments, including the development of standards for designing, conducting, analysing and reporting relevant studies incorporating patient experience data for regulatory submission, and to elucidate how such data can best inform regulatory decisions.
This multistakeholder workshop will bring together patients, healthcare professionals, academia, regulators, and industry to discuss ways to improve the collection and use of patient experience data to achieve patient-centred medicine development and regulation.
The aims of the workshop are to:
The recording of this meeting will be made available after the event.