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Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?
Session Chair(s)
Juan Garcia-Burgos, MD, PHD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Benefit-risk evaluation of medicines should incorporate patients input, values, and preferences. This session will discuss experience and methods used so far and will describe priorities to further enhance implementation pre- and post- authorization. Join the DIA Patient Engagement Community for a follow up round table discussion (session #346 RT L) on Wednesday, June 30, 3:00PM - 4:00PM EDT.
Learning Objective : Recognize the importance and added value of incorporating patients views in benefit-risk throughout the lifecycle of a medicine; Discuss current experience and learnings from incorporating patient input in benefit risk; Discuss existing methodology; Identify implementation challenges, gaps and needs; Discuss the way forward, with focus on pharmacovigilance and risk minimization activities.
Speaker(s)
Lembit Rago, DrMed, MD, PHD
Secretary General, Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Update from CIOMS
Theresa Mullin, PHD
Associate Center Director - CDER, FDA, United States
Update from FDA
Talia Lacroix, MPA
Senior Policy Analyst, Health Product and Food Branch, Health Canada, Canada
Update from Health Canada
François Houyez
Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France
Update from Eurodis
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