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Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines?
Session Chair(s)
Stuart Russel Walker, PhD
Professor and Consultant
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Patients’ perspective on benefits and harms is critical to the development and review of medicines. The challenge for agencies, companies and patients is how and when this should occur. Possible solutions will be presented.
Learning Objective : Discuss how companies and agencies engage with patients to determine the benefit-risk assessment of medicines; Describe how patients and patient advocacy groups would like to be involved in decision making; Compare and contrast the differences in each stakeholder’s perspective on patients’ involvement.
Speaker(s)
EMA Perspective
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
FDA Perspective
John Whyte, DrMed, MD, MPH
WebMD, United States
Chief Medical Officer
Patient Perspective
Durhane Wong-Rieger, PhD, MA
Canadian Organization For Rare Disorders, Canada
President and Chief Executive Officer
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