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Day 1

3rd Real-World Evidence World Congress 2025 Europe

Hilton London Kensington, London, UK

Day 1 - Tuesday 29th April 2025

LATEST REGULATORY LANDSCAPE

  • Regulatory updates in brief
  • Understanding current changes in regulatory guidelines, considerations
  • Establishing data sources and standards
  • Creating a robust RWE strategies in a new regulatory landscape
  • Maintaining data security and privacy
    Best practices and lessons learned
  • Understanding the NICE Real-world Evidence Framework
  • Possible influence it will have on the UK and global health technology assessment (HTA) landscape
  • Comparison with other framework
  • What are we hoping to see on future update of the framework?
  • Establishing how it will support regulatory decision making
  • Role of DARWIN in delivering real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.
  • How will this connect the European medicines regulatory network to the European Commission’s European Health Data Space
  • What are the range of approved healthcare databases enabling distributed data access via DARWIN EU will evolve and expand over time.
  • Robust RWE generation to accelerate drug approval and inform clinical practice during a rapidly evolving pandemic
  • COVID-19 and the wide-ranging role of RWE in informing decision making: From disease monitoring to treatment effectiveness
  • Methodological considerations and cautionary tales of RWE generation in COVID-19
  • Best practices and lessons learned for effectively utilizing RWD/RWE in future pandemics
  • Benefits of understanding differences across stakeholders
  • Multiple stakeholder approach to planning and delivering evidence is required
  • A dedicated strategy to meet their specific evidence needs
  • Determine whether a multiple stakeholder approach is justified.

 

  • New sources of data besides those generally collected
  • Benefits of acquiring new data types
  • Type of data to acquire
  • How and when to get started

 

CURRENT TRENDS AND STRATEGIES

  • How to identify regulatory situations that can benefit from leveraging RWE
  • Choosing an appropriate type of study design
  • Key success factors ensuring fit-for-purpose data and rigorous methods
  • Tips to encourage further use of RWE in regulatory decision-making
  • PRO, HRQoL, RWE, RWD
  • Cost to Society, Health System and Government
  • Technology and Evidence Development
  • 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 is RWD and RWE bringing innovation to patients and gaining approval
  • Importance of RWD in transforming clinical research and clinical trial design
  • Experiences to date and identify practical and technological considerations to further implement real- world clinical research
  • The use of RWD early in the process to boost trial diversity and inclusion
  • Challenge in setting diversity goals early in clinical trial planning
  • Development of a diversity plan to ensure adequate representation of racial and ethnic subgroups in clinical trials
  • Utilizing RWE in the post-marketing setting to complement clinical trial findings and support post- marketing requirements or commitments for safety and efficacy data in a diverse patient population
  • Why is RWE increasingly being recognised and acknowledged as an evolution in product research and development.
  • How does RWE help regulators, pharmaceutical companies and clinicians better identify trends and patterns in patient outcomes
  • How can you make sure that only quality, reliable and relevant information are collected?
  • How is it use to reduce risk and increase safety?
  • Its use in supporting a robust post market surveillance and accelerating products to market
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