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Wednesday, June 30 • 10:00am - 11:00am
#310 SL: Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-600-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Juan Garcia-Burgos, MD, PhD


Update from CIOMS
Lembit Rago, DrMed, MD, PhD

Update from FDA
Theresa Mullin, PhD

Update from Health Canada
Talia Lacroix, MPA

Update from Eurodis
François Houyez

avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →
avatar for François Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France
François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also... Read More →
avatar for Talia Lacroix

Talia Lacroix

Senior Policy Analyst, Health Product and Food Branch, Health Canada, Canada
Talia Lacroix is a Senior Policy Analyst in Health Canada’s Health Products and Food Branch, the area that regulates the safety, quality, and efficacy of drugs and devices in Canada. Talia has spent the last 15 years contributing to regulatory frameworks, guidance, and policy; including... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Lembit Rago

Lembit Rago

Secretary General, Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Dr Lembit Rägo was a Professor of Clinical Pharmacology and Director General of the Estonian State Agency of Medicines until joining WHO Geneva in 1999. When retiring WHO in 2016 Dr Rägo served as the Head of the WHO’s Unit, Regulation of Medicines and Other Health Technologies... Read More →

Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   05: Patient Engagement, Session