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Conference

ISPOR Europe 2025

Conference: ISPOR Europe 2025

Date: November 9 - 12, 2025

Location: Glasgow, Scotland

Explore our integrated real-world evidence and modeling solutions

RWE is driving decisions in regulatory strategy, health economics, early pipeline design and market access. Certara’s expert RWE and modeling team combines >100 collective years of experience with a proven ability to provide timely, strategic value across epidemiology, clinical operations, data science, modeling and biostatistics.

Meet our experts at this year’s ISPOR Europe event Glasgow to learn how Certara’s integrated capabilities support value demonstration throughout drug development.

  • RWE studies – data acquisition, design, execution and analysis
  • Modeling and simulation – advanced modeling (ITCs, ML-based models and surrogate endpoint analysis) and health economic models (cost effectiveness, budget impact) to support strategic positioning and health technology assessment (HTA) value dossiers

Talk to Certara about your HTA strategy and submissions

Certara’s team offers expertise in aligning clinical development plans with HTA requirements, ensuring seamless integrated of evidence and strategy.

  • Early dialogue strategy
  • HEOR and modeling plans
  • Documentation development
  • Post-guidance planning

Where to hear Certara insights and expertise

Issue Panels

Monday, November 10, 10:15 – 11:15
Managed Entry Agreements: Can CEE Countries Mutualize Lessons Learned?

Managed Entry Agreements (MEAs) in CEE are often negotiated individually, leading to inconsistent access and varying financial outcomes. This panel will debate whether MEAs can be mutualized across CEE to offer harmonized frameworks and shared learnings, or if national heterogeneity renders mutualization impractical.

Moderator: Izabela Pieniazek, MSc, Certara

Speakers:

  • Ron Hren, MSc, PhD, Hren, Slovenia
  • Anna Kowalczuk, PhD, MSc, Agency for HTA and Tarriff System, Poland
  • Guenka Petrova, ScD, PharmD, PhD, Medical University of Sofia, Bulgaria
Monday, November 10, 11:45 – 12:45
AI in CEE Health System Decision Making: Can Payers, Patients and Policy Align for Smarter Access?

Central and Eastern European (CEE) payers face a paradox: single-payer systems give them rich RWD streams yet reimbursement dossiers still require long timelines for both creation and adjudication, driven by capacity limitations. This presentation will cover the benefits of AI integration, such as increased efficiency and quality control, while also addressing potential pitfalls including reproducibility issues, unclear regulatory frameworks, and the risk of data manipulation or falsification.

Moderator: Vladimir Guzvic, Health Insurance Fund of Republic of Srpska, Bosnia and Herzegovinia

Speakers:

  • Anna Kowalczuk, PhD, MSc, Agency for HTA and Tariff System, Poland
  • Maciej Grys, Certara, Poland
  • Kevin Kallmes, BS, MA, JD, Nested Knowledge, USA
Monday, November 10, 15:15 – 16:15
Building HTA Capacity in CEE: Is it possible to be made within a common roadmap? From pilot projects to sustainable systems

This panel will debate whether it is feasible to develop a comprehensive regional roadmap guiding Central and Eastern European (CEE) nations from fragmented capacity-building activities toward fully integrated, sustainable HTA infrastructures. It will identify core components—governance, financing, and shared data platforms—tailored to CEE contexts.

Moderator: Malwina Holownia-Voloskova, MSc, PharmD, Certara

Speakers:

  • Oleksandra Oleshchuk, PhD, MD, Horbachevsky Ternopil National Medical University, Ukraine
  • Eva Turk, National Institute of Public Health, Slovenia
  • Kelly Lenahan, BS, MPH, ISPOR

Poster Presentations

How Health Policy Influences HTA Outcomes: Comparative Insights from Ukraine, Moldova and Bulgaria

Authors: Malwina Holownia-Voloskova, Elena Chitan, Oresta Piniazhko, Antoan Rangelov, Grzegorz Obrzut

Are Anti-Obesity Drugs Life-Saving or Lifestyle Medicines? Reframing the Policy and Economic Debate

Authors: Malwina Holownia-Voloskova, Katarzyna Lasota, Marcin Czech

Bridging the Regulatory-Payer Evidence Gap: A Case Study with Six Minute Walk Distance and Mortality

Authors: Noemi Hummel, Agnieszka Kopiec, Emi Naslazi, Ananth Kadambi, Claus C. Becker

Matching-Adjusted Indirect Comparisons (MAICs) and Network Meta-Analyses (NMAs) of the Oral Small Molecule Chaperone Migalastat Versus Intravenous Enzyme Replacement Therapies (ERTs) for Clinical Measures in Fabry Disease

Authors: Noemi Hummel, Agnieszka Kopiec, Matthew Crabtree, Alasdair, Charlotte Sharples, Biliana O. Veleva-Rotse, Neil Johnson, Vera Gielen

Sponsor: Amicus Therapeutics

The Innovative Licensing and Access Pathway (ILAP): Early Pathway Experience, Examining Process Adaptations and Industry Impact

Authors: Elzbieta Soltysiak, Jelena Sostar, Sanja Stanisic

Evaluating the Validity of Immunotherapy in Retreatment and Rechallenge Strategies for Oncology Patients

Authors: Ilona Czarny-Ozga, Kamila Wojas-Krawczyk, Jakub Zolnierek, and Izabela Pieniazek

Systematic Literature Review and Bayesian Network Meta-Analysis of Sugemalimab Plus Chemotherapy Versus Other First-Line Treatments of Metastatic Non-Small Cell Lung Cancer without Sensitizing EGFR, ALK, ROS1 or RET Alterations

Authors: Aneta Gomulka-Pilat, Magdalena Kaczanowska, Agnieszka Kopiec, Izabela Pieniazek

Real-World Evidence in Action: Assessing Drug-Drug Interactions to Drive Value-Based Decisions

Authors: Nadia Quignot ,Erika Braithwaite, Isabelle Ragueneau-Majlessi

Early Systematic PICO Scenario Identification and Prioritization for EU HTA Joint Clinical Assessments

Authors: Kurt Neeser, Elvira Mueller, Vishwas Agashe

Bridging National and EU HTA Regulation: Policy Responses to the JCA Rollout

Authors: Kurt Neeser, Elvira Mueller, Andrea Bernardini, Katarzyna Lasota, Sanja Stanisic

AI in Evidence Synthesis: Have We Reached the Promised Land or Are We Still Wandering in the Desert?

Authors: Maciej Grus, Kevin Kallmes, Jeff Johnson, Roman Casciano

Integration of Germany’s AMNOG Framework with the Joint Clinical Assessment Process

Authors: Elvira Mueller, Kurt Neeser, Linnea Koller

Assessing the Potential Impact of NICE’s Updated HST Routing Criteria on Ultra-Orphan Drugs

Authors: Andrea Bernardini, Jelena Sostar, Vishwas Agashe, April Dominique Ocampo

Access and Evolving Evidence: A European HTA Analysis of Innovative Medicines under Evidence Generation Agreement

Authors: Marine Mathias, Katarzyna Lasota, Sanja Stanisic, Jelena Sostar

From Cost Containment to Modernization: Market Access Updates Across the EU4 and the UK in 2025

Authors: Andrea Bernardini, Katarzyna Lasota, Sanja Stanisic

Additional Resources

Meet with our HTA experts


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