GetReal Conference 2026: Speakers preview the debates shaping the future of decision-ready RWE

As real-world evidence (RWE) becomes more firmly embedded within regulatory and HTA decision-making, questions are emerging around how evidence can be generated, evaluated, and applied with confidence across different decision contexts – issues that will form the focus of discussion at the GetReal 2026 Conference.

Taking place June 29–30 in Utrecht, The Netherlands, the conference will bring together regulators, HTA bodies, industry, patient advocates, and academia under the theme “Translating Real-World Data into Decision-Ready Evidence: Bringing Data, Methods, and Decision Context Together.” Set within a smaller-scale environment designed to encourage open discussion between attendees and speakers, the conference will explore many of the practical challenges now shaping the field, including data quality, methodological rigor, AI-enabled analytics, and the operational realities of meeting growing evidence expectations across healthcare systems.

To preview the meeting, we spoke with several speakers about the questions, challenges, and emerging debates they believe will shape discussions over the two days. Before exploring these topics in more detail, Mariam Bibi, Managing Director of the GetReal Institute, reflects on the theme underpinning this year’s conference:

“The promise of RWE lies not in the data itself, but in our ability to translate it into evidence that informs better decisions. The GetReal Conference 2026 will bring together diverse perspectives to explore how data, methods, and decision context can be aligned to build trust and deliver meaningful impact. Through practical examples, case studies, and shared experiences, attendees will gain valuable insights into how RWD can be transformed into decision-ready evidence that supports healthcare decision-making.”

REGISTER NOW

Can one evidence package satisfy regulators, HTAs, and payers?

Session 1: Understanding the Decision Context: What do Regulators, HTAs & Payers Actually Need?
Moderator: Christine Leopold (Utrecht University)
Speakers: Alexandra Pacurariu (EMA), Niklas Hedberg (TLV), Sahar Barjesteh van Waalwijk van Doorn-Khosrovani (LUMC, CieBAG), Ramiro Gilardino (HTAi Dynamic HTA Working Group) and Francesco Pignatti (EMA)

As RWE is increasingly used across regulatory, HTA, and payer decision-making, stakeholders continue to face questions around whether a single evidence package can realistically satisfy differing evidentiary expectations. While regulators may prioritize safety and effectiveness and evidentiary validity, HTA bodies and payers often focus more heavily on comparative effectiveness, uncertainty, long-term outcomes, and economic impact. This session will explore how evidence requirements diverge across decision-makers and what this means for evidence planning and study design.

Ramiro Gilardino (HTAi Dynamic HTA Working Group):

“The question is increasingly important as healthcare systems move beyond one-time decisions at launch. Regulators, HTA bodies, and payers make different decisions throughout the technology lifecycle, often requiring different evidence at different moments. From a Dynamic HTA perspective, the challenge is less about creating separate evidence packages and more about designing evidence strategies that support continuous learning and decision-making. Using a mock case study, we’ll explore how evidence requirements evolve and what this means for regulatory, HTA, and payer stakeholders.”

What actually makes data “fit-for-purpose”?

Session 2: Data Foundations: Assessing Fitness for Purpose Across the Evidence Lifecycle
Moderator: Seamus Kent (Erasmus University)
Speakers: Alexandra Pacurariu (EMA), Dmitry Etin (Health Data Governance and Interoperability Advisor), Daniala Weir (Utrecht University) and Radek Wasiak (Adigens Health)

As decision-makers place greater scrutiny on RWE submissions, the concept of “fit-for-purpose” data has become central to discussions around evidence credibility. However, important questions remain around how data quality, completeness, relevance, provenance, interoperability, and transparency should be assessed in practice, particularly across different use cases and healthcare settings. At the same time, Europe is rapidly building a stronger data infrastructure through initiatives such as DARWIN EU and the European Health Data Space (EHDS), with the potential to transform how RWE is generated, accessed, and evaluated across countries. This session will examine how stakeholders are defining and operationalizing fitness-for-purpose in an evolving evidence landscape, and explore how emerging European data infrastructure may shape future standards, scalability, and trust in RWE generation.

Dmitry Etin (Health Data Governance & Interoperability Advisor)

“Regulations like the EHDS or initiatives like DARWIN EU are making more health data easier to find and access across Europe. But access is not the same as usability, and it is not always timely. What quality a dataset is and how well they are documented – these are real challenges to address. We must make sure researchers can discover and make use of data that is fit for their needs and can answer their research questions, which we will explore further in our session.”

How is target trial emulation evolving from a research methodology to a regulatory and HTA tool?

Session 3A: Target Trial Emulation: From Framework to Submission
Speakers: Radek Wasiak (Adigens Health), Ciara Coakley (Adigens Health), Xabier Garcia de Albeniz (Adigens Health), Daniala Weir (Utrecht University), Judit Sebares Huerta (Utrecht University), Leo Russo (GetReal Institute) and Manuel Gomes (University College London [UCL])

Target trial emulation (TTE) has emerged as one of the most discussed methodological approaches in RWE, offering a structured framework for addressing causal questions using observational data. As interest grows among regulators, HTA bodies, and industry, attention is increasingly turning from methodological development to practical implementation. This session will explore the opportunities, challenges, and real-world experiences of applying TTE in submissions and decision-making settings.

Radek Wasiak (Adigens Health)

“Regulatory and HTA decision-making is shifting; a single pivotal trial increasingly sits alongside RWE in part because indications in which drugs are developed are defined more narrowly. In that context, target trial framework and its implementation through emulation matter because they provide a structure for generating RWE that is rigorous to be trusted, and transparent to be understood, by stakeholders with very different backgrounds: regulators, clinicians, payers, and industry. The key question is no longer about if the target trial framework is here to stay, but where it goes next. This session is therefore deliberately forward-looking: exploring data feasibility, new use cases, and what each stakeholder group needs to do to realise its potential.”

How can patient voices be embedded more meaningfully throughout the RWE lifecycle?

Session 3B: Patient Engagement: Embedding the Patient Voice in RWE
Speakers: Mariam Bibi (GetReal Institute), Iyar Mazar (Pfizer), James Turnbull (IQVIA) and Marieke Heisen (Patvocates)

Patient engagement is increasingly recognized as a critical component of evidence generation, yet questions remain about how patient perspectives can be incorporated consistently and meaningfully across study design, data collection, analysis, and decision-making. As regulators, HTA bodies, and industry place greater emphasis on patient-centered evidence, stakeholders are exploring how to move beyond consultation toward genuine partnership.

Marieke Heisen (Patvocates)

“Patient involvement and patient experience data (PED) are now essential in RWE because they bring the real-world perspective that clinical trials often miss. When patients are part of the design of studies from the start, that's when research captures what truly matters: long-term outcomes, better quality of life, and impact on their daily lives. Patients define what brings value, and early involvement ensures that this value is measured. Without it, we risk generating evidence that is incomplete and ultimately less meaningful for decision-making. At a time when patient organisations are also producing robust, trusted evidence, this session will challenge the field to move beyond tokenism and enable meaningful, sustained collaboration.”

What will it take for AI-enabled evidence to gain the confidence of decision-makers?

Session 4: AI & Machine Learning: Accelerating the Translation of RWD into Decision-Ready Evidence
Moderator: Shaun Rowark (NICE)
Speakers: Kathi Seidl-Rathkopf (FlatIron), Iain Armstrong (PHA UK), Michel Dumontier, (Universiteit Maastricht, REALM EU), Caspar Safarlou (UMC Utrecht) and James Gwinnutt (IQVIA) 

AI and advanced analytics are increasingly being integrated into evidence generation workflows, creating new opportunities to analyze, curate, and interpret large-scale healthcare data. At the same time, AI tools raise important questions around transparency, reproducibility, governance, and trust. This session will explore how AI-enabled approaches are being evaluated within regulatory and HTA settings and what may be needed for decision-makers to use these outputs with confidence.

Shaun Rowark (NICE)

“AI‑enabled evidence can transform decision‑making by uncovering insights previously out of reach – such as structuring free text records – and by accelerating the scale and speed at which RWD is synthesized. However, progress in RWD has always been guided by transparency. To build confidence in these advanced methods, the same principle must underpin AI‑enabled approaches. Without transparency, trust cannot be established; and without trust, evidence cannot effectively inform decisions.”

What does the first JCA report indicate about the role of RWE in HTA?

Session 6: EU Joint Clinical Assessment: One Year In, What Have We Learned?
Moderator: Christine Leopold (Utrecht University)
Speakers: Anne Willemsen (Chair of the Joint Clinical Assessment Subgroup/Zorginstituut Nederland), Sascha van Boemmel-Wegmann (Flatiron), Niklas Hedberg (TLV), Tarang Sharma (Evidence to Policy) and Martin Parkinson (Thermo Fisher)

With the implementation of Europe’s Joint Clinical Assessment (JCA) framework now underway, attention is turning toward what the first assessments may reveal about the evolving role of RWE in HTA decision-making. Stakeholders are increasingly examining how RWE can support evidence gaps, comparative effectiveness, and long-term outcomes, while also navigating varying expectations around methodology, feasibility, and timelines. This session will reflect on the early implications of JCA for evidence generation strategies across Europe.

Christine Leopold (Utrecht University)

“The publication of the first JCA marks a pivotal moment for the HTA community in Europe and beyond. I am looking forward to discussing with our panelists, who bring perspectives from both HTA bodies and industry, what the first JCA tells us about the future of evidence generation and assessment. We will explore the role that RWE played in the assessment, the lessons that can be drawn for future submissions, and the implications for stakeholders across the evidence ecosystem. We will also examine the PICOs that were considered, the evidence that was submitted, and what this reveals about evidence expectations under the EU HTA Regulation. Don’t miss this unique opportunity to engage in a timely discussion on one of the most significant developments in European HTA.”

How are growing post-approval evidence expectations reshaping RWE?

Session 7: Post-Approval Evidence Obligations: LTFU, Conditional Authorisations & Outcomes-Based Contracts)
Moderator: Lourens Bloem (Utrecht University)
Speakers: Peter Mol (CHMP/CBG-MEB), Andreas Schuil (Orchard Tx), Christine van Hattem (Utrecht University) and Marieke Heisen (Patvocates)

As regulators and HTA bodies increasingly require long-term follow-up, ongoing evidence generation, and post-approval commitments, the role of RWE across the product lifecycle continues to expand. These expectations are creating new operational, methodological, and infrastructure challenges for sponsors, healthcare systems, and data partners alike. This session will explore how stakeholders are approaching long-term evidence generation and what this may mean for the future of registries, observational studies, and real-world data collection.

Lourens Bloem (Utrecht University)

“As cell and gene therapies increasingly enter routine practice, expectations for post-approval evidence generation continue to grow. At Utrecht University, we are working to better understand the role of post-approval evidence requirements to address uncertainties about these treatments. One important area is the long-term follow-up of patients, which can extend to 15 years after treatment and is often performed using registry-based studies. These studies are highly complex to perform. We have investigated the challenges encountered during the conduct of these studies and during the session, will explore the strategies that stakeholders consider important to address or prevent these challenges.”