Menu Back toPatient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
DIA 2021 Global Annual Meeting
Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?
Juan Garcia-Burgos, MD, PhD
- Head of Public and Stakeholders Engagement
- 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.
Update from CIOMS
Lembit Rago, DrMed, MD, PhD
- Secretary General
- Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Update from FDA
Theresa Mullin, PhD
- Associate Director for Strategic Initiatives, CDER
- FDA, United States
Update from Health Canada
Talia Lacroix, MPA
- Senior Policy Analyst, Health Product and Food Branch
- Health Canada, Canada
Update from Eurodis
- Information and Access Director, Health Policy Advisor
- European Organisation for Rare Diseases (EURODIS), France