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DIA 2021 Global Annual Meeting
Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes
Nathalie Bere, MPH
- Patient Engagement
- European Medicines Agency, Netherlands
Patient data helps ensure more patient-relevant regulatory outcomes. Patients are integrated within EMA and FDA’s regulatory procedures with demonstrated value. Relevant, robust and adaptable methodologies are vital to meet the changing health landscape.
Learning Objective : Discuss patient engagement methodologies within regulatory procedures; Identify value of patient input with tangible evidence; Describe the need for continuous, and adaptable, leveraging of the patient perspective for a better balance between scientific objectives and patient goals and ultimately reach more patient-relevant regulatory outcomes.
Marco Greco, PhD
- European Patients' Forum, Belgium
Bruno Sepodes, PharmD, PhD, MPH, MSc
- Vice-Chair-CHMP; Senior Nonclinical Expert INFARMED
- INFARMED, Portugal
Andrea Furia-Helms, MPH
- Director of Patient Affairs, Office of Clinical Policy and Programs
- FDA, United States