Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making
Table of contents
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:
- Achieve a common understanding on what constitutes ‘patient experience data’, including patient engagement, patient preferences and patient reported outcomes.
- Reflect on current methods for collecting and incorporating patient data into medicines development and regulatory assessments
- Consider how direct patient data collection from real-world healthcare can be leveraged and used
- Agree on priorities to enhance the collection and use of patient experience data
The recording of this meeting will be made available after the event.
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Executive summary - Patient experience data in EU medicines development and regulatory decision-making workshop (PDF/234.51 KB)
First published: 17/10/2022
EMA/354012/2020 -
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Agenda - Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making (PDF/416.94 KB)
First published: 22/07/2022
Last updated: 20/09/2022 -
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Presentation - EMA framework for engagement (M. Mavris, EMA) (PDF/408.1 KB)
First published: 28/09/2022 -
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Presentation - How patient engagement can contribute to the development and approval of medicines (Y. Le Cam, EURORDIS) (PDF/256.58 KB)
First published: 28/09/2022 -
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Presentation - How patients can contribute to the safety monitoring of medicines (S. Strauss, MEPRAC) (PDF/503.42 KB)
First published: 28/09/2022 -
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Presentation - Survey results, proposed themes (L. D'Apote, EUCOPE) (PDF/1.02 MB)
First published: 28/09/2022 -
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Presentation - how patient preferences can contribute to development and regulation of medicines (J. Veldwijk, ESHPM) (PDF/1.51 MB)
First published: 28/09/2022 -
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Presentation - Considerations and learnings from use-cases (M. Muller, EFPIA) (PDF/1.03 MB)
First published: 28/09/2022 -
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Presentation - Patient Preference Research (K. Morgan, MPE) (PDF/1.21 MB)
First published: 28/09/2022 -
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Presentation - PRO data generation in practice (C. Torre, UL) (PDF/566.5 KB)
First published: 28/09/2022 -
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Presentation - Clinical Outcome Assessment (COA) Implementation and Utility (E. Dashiell-Aje, EuropaBio) (PDF/694.24 KB)
First published: 28/09/2022 -
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Presentation - European Health Data Space (J. De Barros, EC) (PDF/530.67 KB)
First published: 28/09/2022 -
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Presentation - Data platforms (E. Vroom, WDO) (PDF/928.42 KB)
First published: 28/09/2022 -
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Presentation - Qualification of novel methodologies (T. Vetter, EMA) (PDF/391.65 KB)
First published: 28/09/2022 -
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Presentation - Patient experience data in decision making and future guidance (S. Bhatti, EFPIA) (PDF/513.56 KB)
First published: 28/09/2022 -
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Presentation - ICH Patient-focused drug development (PFDD) initiative (M. Bonelli, EMA) (PDF/183.73 KB)
First published: 28/09/2022 -
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Presentation - Tools to collect patient generated data (T. Stamm, MUV) (PDF/7.47 MB)
First published: 28/09/2022 -
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Presentation - Patient's Reported Outcomes (PRO) role in clinical development and approval decisions (A.Elferink, MEBSAWP) (PDF/1.21 MB)
First published: 29/09/2022