13th RWE, MARKET ACCESS,​ PRICING & REIMBURSEMENT

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

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KEY INDUSTRY EXPERT SPEAKERS

Available Shortly

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Available Shortly

Senior Representative

Recordati Rare Diseases

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access

Available Shortly

Senior Representative

Global Market Access and Pricing Head

Available Shorlty

Swami Nathan,

Head, US/Global Pricing and Contracting

Regeneron

Available Shortly

Senior Representative

Pharma

INTRODUCTION

The 13th RWE, Market Access, Pricing & Reimbursement 2026 Europe takes place at a critical juncture for European healthcare, where the convergence of real-world evidence (RWE), evolving HTA frameworks, pricing pressures, and digital transformation is redefining how value is assessed and access is granted. As the EU HTA Regulation moves into implementation, and healthcare systems face ongoing financial constraints, stakeholders must adapt to a rapidly changing environment that demands greater alignment, transparency, and innovation.

Across Europe, expectations around evidence generation are shifting. While randomised controlled trials (RCTs) remain essential, there is increasing reliance on RWE to complement clinical data and support decision-making across regulatory and HTA processes. The introduction of Joint Clinical Assessments (JCA) presents an opportunity to streamline evaluations across member states, but also raises important questions around methodological consistency, data quality, and national-level interpretation. As a result, organisations must adopt integrated evidence strategies that align clinical development with real-world insights to meet the needs of multiple stakeholders.

At the same time, pricing and reimbursement landscapes are becoming more complex and constrained. External reference pricing, policy reforms, and economic pressures are intensifying scrutiny on the value of new therapies. This is particularly evident for high-cost innovations, where payers are increasingly demanding clear and measurable outcomes. In response, the industry is advancing innovative pricing models, including outcomes-based agreements, indication-based pricing, and risk- sharing approaches. However, scaling these models across diverse European markets requires robust data infrastructure and stronger collaboration between industry, payers, and regulators.

A key priority is the shift toward patient-centric value frameworks. Decision-makers are placing greater emphasis on outcomes that matter most to patients, such as quality of life and long-term impact. This is especially important in areas like advanced therapies and rare diseases, where traditional evidence pathways are often limited and uncertainty remains high. Incorporating patient- reported outcomes and leveraging longitudinal RWE are becoming essential for demonstrating meaningful and sustainable value.

In parallel, digital transformation is accelerating the evolution of market access. Advances in artificial
intelligence, data analytics, and digital health technologies are enabling more dynamic, data-driven
decision-making. From wearable devices to integrated health data platforms, new sources of real-world
data are expanding the evidence base. However, this progress also introduces challenges around data
interoperability, governance, privacy, and ethical use, particularly within the context of GDPR and
cross-border data sharing.

This congress brings together senior leaders and experts from across the healthcare ecosystem to
explore these critical issues. Through focused sessions, panel discussions, and real-world case studies,
participants will gain practical insights into aligning evidence with HTA requirements, navigating pricing and reimbursement complexities, embedding patient-centricity, and leveraging digital
innovation to improve access outcomes.

Ultimately, the 13th RWE, Market Access, Pricing & Reimbursement 2026 Europe provides a platform for collaboration, knowledge exchange, and forward-thinking strategy. As Europe moves toward a more harmonised and data-driven future, the ability to translate evidence into value and value into patient access will be more important than ever.

We look forward to welcoming you to the RWE, MAPR 2026 congress!

Gain insights on:

  • Evaluate the role of real-world evidence (RWE) in European HTA and regulatory decision-making
  • Differentiate between RCT and RWE methodologies and assess their application in market access strategies
  • Interpret the implications of the EU HTA Regulation and Joint Clinical Assessments for evidence generation and submissions
  • Analyze variations in pricing, reimbursement, and market access pathways across key European markets
  • Develop integrated market access strategies that align clinical, HEOR, and commercial functions
  • Assess the impact of pricing pressures, policy changes, and budget constraints on access and reimbursement decisions
  • Compare innovative pricing and reimbursement models, including outcomes-based and value-based agreements
  • Evaluate the integration of patient- centric outcomes, including PROs, into HTA and reimbursement frameworks
  • Examine market access challenges and reimbursement approaches for advanced therapies and rare diseases
  • Assess the role of real-world data in demonstrating long-term outcomes and value post-launch
  • Evaluate the use of digital technologies, AI, and advanced analytics in pricing and market access decision-making
  • Formulate forward-looking strategies to adapt to evolving European policies, data ecosystems, and collaborative healthcare models

Who Should Attend

Network with members of the boards, VP’s, Directors, Heads/Chiefs and Senior Managers of leading biopharmaceutical and biotech companies, government, CRO and solution providers involved in:

  • Real-World Evidence
  • Real-World Data
  • Clinical Research and Development
  • Data Science, Technologies and Analytics
  • Clinical Research
  • Epidemiology
  • Health Economics and Outcomes Research
  • Market Access
  • Reimbursement
  • Patient Outcomes
  • Drug Pricing
  • Health Economics and Outcomes Research
  • Payer Relations/ Evidence
  • Regulatory Affairs, Policy
  • Public/ Government Affairs
  • Payers, HTA Officials and Physicians
  • Business Development
  • Marketing
  • Commercial Executives
  • Product Launch
  • Commercialization
  • Value Strategy
  • Product Strategy
  • Forecaster
  • Finance Officer
  • Wearable Sensors
  • Electronic &
  • Medical Records
  • Lab & Biomarkers
  • Medical and Pharmacy data
  • Technology Science and Development
  • Social Media
  • Academia
  • Pharma and Biotech  

The program

13th RWE, MARKET ACCESS, PRICING & REIMBURSEMENT World Congress 2026 Europe

Day 1 - Thursday 3rd September 2026 - Hilton London Kensington, London, UK

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

RWE Integration in European HTA & Evidence Strategy

  • EU HTA Regulation and Joint Clinical Assessments (JCA)
  • Acceptance of RWE across member states
  • Methodological challenges and credibility
  • Future outlook for hybrid evidence models

Moderator:

Panelist:

  • Key requirements under Joint Clinical Assessments (JCA)
  • Aligning clinical development with HTA expectations
  • Evidence submission timelines and coordination challenges
  • Strategic implications for pan-European launches
  • Study designs that meet payer and HTA standards
  • Selecting appropriate real-world data sources
  • Ensuring reproducibility and methodological rigor
  • Addressing cross-country evidence expectations
  • Integrating RWE endpoints into trial design
  • Hybrid trial models (RCT + RWE integration)
  • Early planning for post-launch evidence generation
  • Cross-functional alignment across clinical and access teams
  • Identifying and mitigating selection bias
  • Ensuring data completeness and consistency
  • Transparency in methodologies and reporting
  • Building trust with regulators and payers
  • Opportunities from EU data-sharing initiatives
  • Accessing cross-border datasets
  • Data interoperability challenges
  • Governance and compliance considerations
  • Overview of product and market context
  • Evidence strategy and RWE integration
  • Key success factors in HTA acceptance
  • Lessons learned for future submissions

Pricing & Market Access Strategies in a Constrained European Landscape

  • Structure and mechanics of alternative pricing models
  • Benefits and risks for payers and manufacturers
  • Implementation challenges across Europe
  • Real-world examples of adoption
  • Review use of RWD to guide pipeline and portfolio strategy
  • Considerations when using RWD to inform internal decisions
  • The growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE
  • The importance of data quality and methodological transparency in RWE.
  • How to use patient-level external controls in a comparative efficacy analysis
  • Explore the evaluation and selection of index dates for RW subjects
  • Discuss the impacts and potential biases of common index date selection methods
  • Tips for considering which indexing method to use in studies that use external controls
  • Macro-economic pressures on healthcare budgets
  • Policy reforms affecting pricing decisions
  • Increasing scrutiny on high-cost therapies
  • Strategic pricing adaptations
  • Structuring value narratives effectively
  • Integrating clinical, economic, and patient outcomes
  • Tailoring dossiers for different markets
  • Common mistakes in value communication
  • External reference pricing and cross-border impact
  • National vs EU-level pricing tensions
  • Balancing access, affordability, and innovation
  • Increasing payer influence

13th RWE, MARKET ACCESS,​ PRICING & REIMBURSEMENT World Congress 2026 Europe​

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

Day 2 - Friday 4th September 2026 - Hilton London Kensington, London, UK

Patient-Centric Value, Outcomes & Advanced Therapies

  • Patient-reported outcomes (PROs) in HTA
  • Equity and access disparities
  • Outcomes-based agreements
  • Value frameworks beyond clinical endpoints

Moderator:


Panelist:

  • Role of patient-reported outcomes (PROs)
  • Incorporating patient voice in HTA frameworks
  • Measuring quality of life and functional outcomes
  • Barriers to adoption across Europe
  • Structuring outcomes-based reimbursement contracts
  • Data collection and performance tracking
  • Operational and administrative challenges
  • Scalability across multiple markets
  • Evidence limitations in small populations
  • High upfront costs and payer concerns
  • Regulatory and HTA complexities
  • Access disparities across countries
  • Annuity and staged payment models
  • Risk-sharing agreements
  • Linking payment to long-term outcomes
  • Financial sustainability considerations
  • Post-launch evidence requirements
  • Use of registries and longitudinal data
  • Demonstrating durability of treatment effect
  • Supporting re-assessment and reimbursement
  • Patient journey and unmet need
  • Access barriers and solutions implemented
  • Outcomes measurement approach
  • Impact on access and patient outcomes

Digital Transformation, Data & the Future of Market Access

  • Leveraging predictive analytics for pricing and reimbursement decisions
  • Scenario modelling to optimise launch and access strategies
  • AI-driven insights to strengthen payer engagement and negotiations
  • Challenges, limitations, and governance of AI in decision-making
  • Expanding beyond traditional data: wearables, apps, and remote monitoring
  • Validating digital endpoints for regulatory and HTA acceptance
  • Integrating new data streams into evidence generation strategies
  • Opportunities and risks in using patient-generated health data
  • Overcoming fragmentation across national health data systems
  • Advancing interoperability standards and cross-border data sharing
  • Role of European data initiatives and collaborations
  • Public-private partnerships enabling scalable data ecosystems
  • Navigating GDPR and evolving European data regulations
  • Ethical considerations in secondary use of health data
  • Digital platforms for payer and stakeholder engagement
  • Ensuring transparency, trust, and security in data-driven access models
  • Transitioning from static evidence to real-time, data-driven decision-making in pricing and reimbursement
  • The growing role of AI and advanced analytics in shaping market access and payer negotiations
  • Overcoming data fragmentation and interoperability challenges across European healthcare systems
  • Balancing innovation with regulation, GDPR compliance, and ethical use of health data
  • Ensuring equitable, patient-centric access in an increasingly digital and data-driven ecosystem

Moderator:


Panelists:

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Testimonials

Thank you for a good experience with the PARADIGM Global Events… very high level, very good Organization, we overpassed our expectatives, we will be pending for another congress related to pharmaceutical and biotech… we learned a lot, and i think that the content of agenda was state of the art, thank you again.
SALVADOR BERRIOS
ERP/ CRM / Product Configurator Manager
The consistently high quality of international faculty was most impressive. It was also obvious that they were carefully chosen not only for their particular expertise but also for their ability to communicate the subject matter to clinical and non-clinical participants alike. As market access consultant for pharma clients of various sizes, I now feel much better prepared to explain the nuances & dynamics involved in bringing their products to market. In addition, I am in a much better position to intelligently advice my clients & help them set realistic expectations
THOMAS MARTIN
Associate Vice President, VCGA - Quintiles
I was impressed with the organization of this event. I attend many conferences per year and find the organizers on site to be detached and not focus on good service to the delegates. This team was even providing weather forecast warning to ensure everyone was aware and made appropriate plans. Well Done.
ADRIANA E. MANZI
PhD, Managing Director, Atheln, Inc

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