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Registries: Solving the Real Life Challenges
Session Chair(s)
Julie O'Brien, PhD
EFPIA; Senior Director, Head Europe and International Regulatory Policy
Ireland
This is a Collaborative Hub session, which is a new type of session at the DIA Europe meeting. This will be a hands-on session where all participants will engage in discussion at roundtables on key questions pertinent to the use of registries. Three experts in registries will frame the session at the beginning, focusing on the current challenges regarding the use of registry data in EU regulatory and Health Technology Assessment (HTA) decision making, and identifying potential solutions for more effective use of registry data in the decision-making process. This session is intended to capture measurable outcomes and tangible next steps and promote cross pollination between existing and future initiatives on registries. This session will appeal to regulators, patient advocates, academics, industry and registry owners.
Learning Objective : The objective of this session is to improve participants’ knowledge about the current practices regarding the use of registry data in the EU regulatory and Health Technology Assessment (HTA) decision making. In addition, we aim to discuss the challenges and potential solutions for more effective use of registry data in the decision-making process.
Speaker(s)
Registry Data to Support Patient-Centred Regulatory and HTA Decision-Making: Perspectives from the More-EUROPA Project
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
EMA’s Registry-Based Study Guideline: From Conception to Implementation - Key Learnings and Impact
Gracy G Crane, PhD, MS
Roche, United Kingdom
Policy Lead
Maurille Feudjo Tepie
UCB, United Kingdom
VP & Head, GLobal RWE and Digital Sciences
Panelist
Estelle Michael
UCB, Belgium
RWE Policy & External Engagement Lead
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