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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)
Hans-Georg Eichler, MD, MSC
Consulting Physician, Austrian Association of Social Security Bodies, Austria
EMA Perspective
John Whyte, DrMed, MD, MPH
Chief Medical Officer, WebMD, United States
FDA Perspective
Durhane Wong-Rieger, PHD, MA
President and Chief Executive Officer, Canadian Organization For Rare Disorders, Canada
Patient Perspective
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