3rd Real-World Evidence World Congress 2025 Europe

Trends and Strategies to Achieve Optimum Patient Access to Healthcare

Hilton London Kensington, London, UK
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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:

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:

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Key Industry Expert Speakers

Full Lists Available Shortly.  

Riad Dirani

VP, Global HEOR, Medical Operations & Excellence

Teva

ESTHER NZENZA

Founder and CEO

Decisive Consulting Ltd.

RYOTARO ISHIKAWA

Global Market Access Director

Novartis

JOSIE GODFREY

Co-Founder and CEO, Realise Advocacy, Director

JG Zebra Consulting

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

Senior Level Executive

Available Shorlty

Senior Level Executive

Available Shorlty

Senior Level Executive

Available Shorlty

Senior Level Executive

Available Shortly

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

SPONSORS & EXHIBITORS

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Group Discounts Are Also Available

Advocates / Patient / Non Profit

Full Price
£499
  • Full Access - 2 Day Conference
  • All Day Refreshments & Lunches
  • Conference Documentations
  • Networking Drinks Reception

Standard Registration Rate

Full Price
£1299
  • Full Access - 2 Day Conference
  • All Day Refreshments & Lunches
  • Conference Documentations
  • Networking Drinks Reception

Testimonials

what people say

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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