GetReal Institute 2024 Annual Conference: Editor’s highlights

Written by Laura Dormer, Editor

Following the inaugural event in March 2023, the GetReal Institute is now gearing up for its second annual conference, taking place May 14–15, 2024 in Utrecht, The Netherlands. The Evidence Base team will be attending the conference again this year, where we’ll be providing daily roundups as well as deeps dives into some of the presentations. Here, I share an overview of the sessions and speakers to look out for at the event.

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GetReal Institute 2024 Annual Conference

As health technology assessment (HTA) bodies and regulatory agencies are increasingly recognizing the importance of incorporating real-world evidence (RWE) into their decision-making processes, there is a growing need for the development of robust methodologies to collect, analyze and interpret RWE to ensure its validity and reliability for informing HTA and regulatory decisions. This necessitates collaboration and a shared understanding among industry, policymakers, researchers and regulatory bodies to define best practices and navigate the complexities of RWE generation and utilization. With the main theme of ‘A Growing Convergence: RWE for Regulatory and HTA Decision-Making’, the 2-day GetReal Institute 2024 Annual Conference aims to foster these discussions by bringing together leading experts to share their invaluable insights and experience on the generation, analysis and utilization of RWE.


Day One – Shaping the future of real-world evidence in regulatory and health technology assessment decision-making

Shahid Hanif (GetReal Institute) will open Day One of the conference by moderating a panel discussion on, ‘“Throwback” to last year, how is regulatory and HTA converging?‘ The panel includes Anna Steenrod (Roche), Francois Houyez (EURORDIS) and Irene Nunes (Genmab), who will provide a multistakeholder reflection on developments in the field since last year’s conference.

This will be followed by an update on the use of RWE in regulatory decision-making, featuring Patrice Verpillat (European Medicines Agency [EMA]) and Alison Cave (Medicines and Healthcare products Regulatory Agency [MHRA]). The session, ‘What does good look like? Progress in Regulatory Decision-Making with RWE‘, will be moderated by Álmath Spooner (AbbVie).

During ‘The Big Debate: This house believes we are making good progress towards adopting RWE as part of the HTA Regulation‘, HTA representatives will delve into the current landscape of European HTA bodies and their progress in incorporating RWE into their assessments. Francois Houyez will be joined by Karen Facey (RWE4Decisions), Inka Heikkinen (MSD) and Juan Carlos Rejón Parrilla (Andalusian Health Technology Assessment Unit [AETSA]).

The conversation will continue by exploring the practical experiences of applying RWE methods for HTA decision-making. Stephen Duffield (NICE), Soledad Isern de Val (HTA agency in Aragón [IACS]) and moderator Anja Schiel (Norwegian Medicines Agency [NOMA]) will provide their unique insights during the session ‘Deploying methods in HTA: the experiences of HTA bodies using RWE methods‘.


Day Two – Advancing RWE methods and the future outlook

During Day Two of the GetReal Institute 2024 Annual Conference, there will be two sessions on ‘Methods Deep-Dive: A Scientific Discussion on RWE Methods Being Applied‘. Attendees will hear from experts speakers providing ‘hands-on’ insights and use cases exploring external control arms, the implementation of common data models, and the pragmatic and decentralized approaches of future trials.

The keynote will explore ‘A Vision For The Future: What If We Accelerate The Convergence of Regulatory & HTA?‘ Patrice Verpillat will envision a future where the convergence of RWE within and across regulatory and HTA bodies is accelerated to enhance the evidence base in submissions, swiftly address uncertainties, and ultimately facilitate timely access for patients.

In the closing discussion of the day, the ‘Regulatory & HTA Town Hall‘, stakeholders will share their voice and opinions in advancing the acceptability of RWE. Moderated by Niklas Hedberg (TLV), the discussants include:

  • Iñaki Gutierrez Ibarluzea – Basque Foundation for Health Innovation and Research (BIOEF)
  • Elena Petelos – University of Crete/Health Technology Assessment international (HTAi)
  • Wim Goettsch – Utrecht University/Sustain-HTA
  • Francois Houyez – EURORDIS
  • Patrice Verpillat – EMA
  • Bettina Ryll – Melanoma Patient Network Europe

Meet The Evidence Base at the GetReal Institute 2024 Annual Conference

If you’re attending the GetReal Institute 2024 Annual Conference and are interested in meeting with Laura Dormer and Jo Walker of The Evidence Base, please email Jo directly.