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Virtual

Jun 27, 2021 10:00 AM - Jul 01, 2021 4:30 PM

DIA 2021 Global Annual Meeting

Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes

Session Chair(s)

Nathalie  Bere, MPH

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)

Marco  Greco, PHD

Marco Greco, PHD

President , European Patients' Forum, Belgium

Panelist

Bruno  Sepodes, PHARMD, PHD, MPH, MSC

Bruno Sepodes, PHARMD, PHD, MPH, MSC

Vice-Chair CHMP (EMA); Senior Expert INFARMED, INFARMED, Portugal

Panelist

Andrea  Furia-Helms, MPH

Andrea Furia-Helms, MPH

Director of Patient Affairs, Office of Clinical Policy and Programs, FDA, United States

Panelist

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