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Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes
Session Chair(s)
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.
Speaker(s)
Panelist
Marco Greco, PHD
European Patients' Forum, Belgium
President
Panelist
Bruno Sepodes, PHARMD, PHD, MPH, MSC
INFARMED, Portugal
Vice-Chair CHMP (EMA); Senior Expert INFARMED
Panelist
Andrea Furia-Helms, MPH
FDA, United States
Director of Patient Affairs, Office of Clinical Policy and Programs