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DIA 2021 Global Annual Meeting


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

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.

Speaker(s)

Lembit  Rago, DrMed, MD, PhD

Update from CIOMS

Lembit Rago, DrMed, MD, PhD

  • Secretary General
  • Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Theresa  Mullin, PhD

Update from FDA

Theresa Mullin, PhD

  • Associate Director for Strategic Initiatives, CDER
  • FDA, United States
Talia  Lacroix, MPA

Update from Health Canada

Talia Lacroix, MPA

  • Senior Policy Analyst, Health Product and Food Branch
  • Health Canada, Canada
François  Houyez

Update from Eurodis

François Houyez

  • Information and Access Director, Health Policy Advisor
  • European Organisation for Rare Diseases (EURODIS), France