- 29th - 30th April 2025
- London, UK
3rd Real-World Evidence World Congress 2025 Europe
Trends and Strategies to Achieve Optimum Patient Access to Healthcare
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RWE, MARKET ACCESS, PRICING & REIMBURSEMENT
Dear Colleagues,
Real-world evidence is the clinical evidence regarding the usage and potential benefit/risk of medical products derived from analysis of RWD. These are empirical data acquired outside the framework of randomized controlled trials and originated from routine clinical practice. RWD is data associated with patient health status and/or the delivery of health care routinely collected from a variety of sources such as patient disease registries, electronic health records (EHRs), patient-generated data, other sources such as wearables and mobile devices, etc. It is gathered and converted to RWE through robust analytics and a validated approach. The focus on RWE affects every stage of the drug/device development lifecycle.
With exponential growth in the use of technologies such as computers, medical devices, wearables, and biosensors to collect and amass considerable amounts of health-related data along with the development of advanced, new analytical capabilities, these data can now be analyzed. The information collected is increasingly accessible and useful for outcomes research and regulatory purposes and can be applied to medical product development and approval. RWE is now being used by medical product developers to aid clinical trial designs and observational studies to generate innovative, new treatment approaches. The healthcare community and regulatory agencies utilized RWE to develop guidelines and decision support tools for use in clinical practice and to make informed healthcare and regulatory decisions.
While RWE is playing an increasingly critical role in supporting every aspect of successful evidence generation programs and presents immense possibilities, it also brings substantial challenges that continue to cast shadows on its validity. Concerns such as data viases, data quality, and the possible false results due to data mining, progress have diminished primarily.
The 2 days congress aims to provide cutting-edge, and comprehensive discussions in a collaborative format to improve standards and practice for the collection and analysis of data for better decision-making for health globally. We are putting together an agenda that focuses on “The significance of Real-World Evidence in changing the future of trial design, drug development and healthcare to improve patient outcomes”. We are gathering high-caliber expert speakers to participate and share their knowledge and expertise through Keynotes, Presentations, and Panel discussions.
We look forward to welcoming you to the RWE 2025 congress!
Sincerely yours,
Jocelyn Raguindin
Conference Director
Paradigm Global Events
GAIN LATEST INSIGHTS ON:
- Acknowledge the importance of RWD and RWE not only to better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support.
- Identify future opportunities in leveraging Real-world data and Real-world evidence for regulatory decision-making that addresses the need to adequately update and develop timely and accurate guidelines.
- Understanding the promise of real-world data as a potential catalyst for addressing challenges faced in clinical trials, to assist in study design and as a data source to facilitate clinical research.
- Recognise crucial aspects of real-world data that can have an effect on data quality and approaches to addressing these factors
- Gain insights and examine how stakeholders are impacted by real-world data and real-world evidence
- Recognize the regulatory and clinical development framwork that made an RWE-enabled development strategy attractive
- Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization
- Evaluate future applications of real-world evidence in drug development, clinical trials, and evidence generation
- Network with like-minded professionals focused on real-world data and real-world evidence to deliberate on best strategies, practices and lessons learned
- Global and European MA trends, collaboration and spillovers
- Payer & industry perspective for better access
- Patient-centred approach for better outcome
- And much more...
WHO SHOULD ATTEND?
This Congress will provide information to pharmaceutical and biotech companies, researchers, physicians, institutional review boards (IRBs), patient organizations and advocates, and regulatory agencies about the implementation of Real-World Evidence.
Network with members of the boards, VP’s, Directors, Heads/Chiefs, and Senior Managers of leading Pharmaceuticals and Biotech Companies, Government, CRO’s and Solution Providers Involved in:
- Real-World Evidence
- Real-World Data
- Clinical Research and Development
- Data Science, Technologies and Analytics
- Medical Affairs
- Regulatory Affairs and Policy
- Regulatory Science
- RWE, and Data Management
- Policy
- Clinical Development
- Clinical Research
- Epidemiology
- Health Economics and Outcomes Research
- Pharmacovigilane
- Technology Science and Development
- Informatics
- Clinical Studies
- Clinical Operations
- Market Access
- Reimbursement
- Patient Outcomes
- Drug Pricing
- Health Economics and Outcomes Research
- Payer Relations/ Evidence
- Medical Affairs, Global Patient Advocacy & Alliances
- Government Policy and Advocacy
- Digital Patient Experience Lead
- Clinical Operations
- Clinical Insights and Experience
- Head of Strategy, Access Services
- Product Lifecycle
- Patient and Disease Registries
- Wearable Sensors
- Electronic & Medical Records
- Lab & Biomarkers
- Medical and Pharmacy data
- Social Media
- Mortality
- Omics
- Public / Government Affairs
- Payers, HTA Officials and Physicians
- Business Development
- Marketing
- Commercial Executives
- Academia
- And much more...
Key Industry Expert Speakers
Full Lists Available Shortly.
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Senior Level Executive
Available Shorlty
Schedule
Content Rich Program Agenda! Featuring Keynote Presentations, Stream Sessions, Panel, and Round Table Discussions.
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
CHALLENGES AND POTENTIALS
- Challenges that could inhibit the administration and efficiency of RWE
- Best practices and lessons learned from other industries
- Collaboration between regulators and RWD/RWE organisations to develop collective experience so that RWE use can be better regulated
- Analyzing RWD to determine brand marketing effectiveness
- Major factors contributing to the pharmaceutical industry’s excitement about RWE
- Addressing the challenges of collecting and consolidating RWD data that can be put to good use.
- Important role of RWE clinical trials
- Real-world data and evidence as a more integral part of the drug development process.
- How are patient registries used to generate real-world data for rare diseases and orphan drugs?
- Does different stakeholder types have different RWE information needs for decision making?
- Well-targeted evidence which encourages orphan medicine adoption by supporting the approval, reimbursement, and prescribing
- 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.
- The shift from RCT to RWE; closing the gap
- Best practices and lessons learned in developing robust RWE studies
- Using Real-World Evidence to accelerate market access
- Example of technologies currently being used to harness data
- Are there pitfalls in using these technologies?
- How are these new technologies providing valuable understanding of the use of RWE in real-world settings
- Upcoming development
- Collection of high-quality patient-centered data relevant to the design, conduct, and translation of real- world research.
- Applying qualitative patient experience data to make informed study design decisions
- Recommendations that may improve the patient centricity of RWE
- Why personalised medicines require RWE and disruptive technologies intervention?
- Data that have potential to be implemented in personalized medicines discovery
- How will RWE curve the future path of personalized, precision medicines
- Glimpse into a future of next-generation medicine
- Recent advances in scientific research and technologies
- Main areas that need improvement
- Innovative strategies needed to engage patients and generate the necessary evidence to propel new advances into the clinic
- Latest changes in RWE landscape and its advantages
- What exciting new breakthroughs exist for RWE?
- The next big innovations and advances in RWE
- Perspective on future directions and harmonisation
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- Conference Documentations
- Networking Drinks Reception
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Location
- Hilton London Kensington
- London, UK
- info@paradigmglobalevents.com
- +44 (0) 207 193 3485