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