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Session 7: Part II: Real-World Evidence in Regulatory and HTA Decision-Making: Global and Regional Perspectives on Moving from Pilots to Operation
Session Chair(s)
Álmath Spooner, PhD
Head of Europe Regulatory Policy & Intelligence (RPI)
AbbVie, Ireland
Lembit Rago, DrMed, MD, PhD
Secretary General
Council for International Organizations of Medical Sciences (CIOMS), Switzerland
This session will aim to showcase the draft report and review that has been undertaken by CIOMS and EMA, respectively, into the application of real-world evidence. We will attempt to tease out critical success factors in delivering RWD/E for multiple stakeholders’ needs. The use of real-world data and real-world evidence in regulatory and HTA decision making has been under discussion for more than a decade. However, where it would have been a novelty several years ago, it is now playing an increasingly significant role through early to late-stage drug development and in regulatory and market access decisions. This is observed in the context of rare and orphan disease and other unique patient populations such as children and women of child-bearing age (WOCBA), but it is also of relevance for broader patient populations, particularly where there is a need to demonstrate efficacy and effectiveness in the longer term.
Speaker(s)
Introduction to the session
Álmath Spooner, PhD
AbbVie, Ireland
Head of Europe Regulatory Policy & Intelligence (RPI)
Introduction and Background to CIOMS Draft Report
Lembit Rago, DrMed, MD, PhD
Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Secretary General
Global and regional harmonization initiatives relating to RWE
Gracy G Crane, PhD, MS
Roche, United Kingdom
Policy Lead
Regulator-led RWE Studies – an EMA Review of the Experience Gained
Stefanie Prilla, DrSc
European Medicines Agency, Netherlands
RWE Coordinator
Executing Real-World Studies – Use Case
Daniel Prieto-Alhambra
and Professor at University of Oxford and Erasmus MC, United Kingdom
Section Head - Health Data Sciences at Botnar Research Centre
Application of RWE in HTA decision-making: use case
Elena Petelos
University of Maastricht, HTAi, Netherlands
Lecturer of Evidence-Based Medicine and Evidence-Informed Policy
Panel Discussion: Real world evidence in regulatory decision making – critical success factors?
Estelle Michael
UCB, Belgium
RWE Policy & External Engagement Lead
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