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Monday, June 28 • 2:30pm - 3:30pm
#132 SL: Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Nathalie Bere, MPH


Marco Greco, PhD

Bruno Sepodes, PharmD, PhD, MPH, MSc

Andrea Furia-Helms, MPH

avatar for Bruno Sepodes

Bruno Sepodes

Vice-Chair-CHMP; Senior Nonclinical Expert INFARMED, INFARMED, Portugal
Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European... Read More →
avatar for Nathalie Bere

Nathalie Bere

Patient Engagement, European Medicines Agency, Netherlands
Nathalie Bere has a BSc in Psychology and a Master in Public Health. Nathalie has been working with European Medicines Agency (EMA)since 1998 and is currently responsible for its engagement with patients and consumers. Patients bring specific knowledge and expertise from their real-life... Read More →
avatar for Andrea Furia-Helms

Andrea Furia-Helms

Director, Office of Patient Affairs, FDA, United States
Andrea Furia-Helms is the Director of the Office of Patient Affairs (OPA) in the Office of the Commissioner. She collaborates with patient communities, the FDA medical product Centers and other offices to incorporate patient and caregiver perspectives in cross-cutting regulatory meetings... Read More →
avatar for Marco Greco

Marco Greco

President, European Patients' Forum, Belgium
Dr Marco Greco is the President of the European Patients' Forum (EPF).He currently sits on the Management Board of the European Medicines Agency (EMA) and acts as an observer on the Patients and Consumers Working Party,on behalf of the Board.He works as an attorney at his law firm,focusing... Read More →

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum