News & events

Nathalie Niclaus and Barbara D’haene attended the Medical Devices Conference in Belgium organised by Haelixia; a full-day event providing essential updates on the MDR/IVDR legal framework and its impact on the medical technology sector in Belgium and Europe.

Throughout the day, participants received in-depth insights on both pre-market and post-market requirements. Many experts from the FAMHP (Federal Agency for Medicines and Health Products) shared their perspectives and presented on crucial topics, including:

• Innovation and technology: the regulatory challenges and opportunities for AI in medical devices and connected technologies, with attention to the AI Act and GDPR.
• MDR/IVDR implementation: transition timelines, the role of EUDAMED, and the European regulatory outlook.
• Pre-marketing strategies: the importance of clinical investigations, preparing and submitting documents, and the impact of IVDR on clinical trials.
• Post-market responsibilities: materiovigilance, tackling shortages, and hospitals’ obligations under MDR/IVDR.

https://www.healixia.be/meetings-detail-pagina/696/medical-devices-conference

Following its General Assembly, pharma.be hosted the event “Keys to a healthy society: from policy to action”, exploring how policy and individual action can together build a healthier society.

• Frédéric Clais (Eli Lilly Belgium, Chair pharma.be) highlighted Belgium’s role as a hub for biopharmaceutical innovation, stressing that innovation must be embedded in strong policy focused on prevention, access, and competitiveness.
• Minister Frank Vandenbroucke presented his priorities for the next legislature, announcing the new Fast & Early Access procedure to speed up patient access to innovative therapies while safeguarding quality.
• Dr. Sam Proesmans (emergency physician and author) underlined the impact of lifestyle choices and the need for education, prevention, and reliable information in tackling today’s health challenges.
• Caroline Ven (CEO pharma.be) called for urgent action to stimulate innovation in Belgium and Europe, ensuring patients and society benefit from ongoing investments in R&D.

Conclusion

The event underscored that health is a shared responsibility. By working together, Belgium can strengthen its position as a hub for innovation and build a healthier, more resilient society.

https://pharma.be

Barbara D’haene attended the training ‘CRPPP for Consultancy Professionals’ organized by beMedTech

Since 2022, Belgium has streamlined its reimbursement process for diagnostic tools, medical nutrition, and magistral preparations. These requests are now handled by the CRPPP (Commission de remboursement des produits et des prestations pharmaceutiques in French) or CTFPV (Commissie voor Terugbetaling van Farmaceutische Producten en Verstrekkingen in Dutch).

Read our blog post for more information about the procedure

LIVV will be attending the World Evidence, Pricing, and Access (EPA) Congress 2025, taking place on March 5–6 at the RAI Congress Centre in Amsterdam.

Europe’s leading healthcare evidence, pricing, and access congress will feature over 250 speakers across 9 tracks, with more than 1,500 delegates and 120 exhibitors. The congress covers critical topics such as market access, pricing, reimbursement, rare diseases, health technology assessments, and health economics and outcomes research.

Our team will be presenting a poster titled “Visualizing Reimbursement Criteria for Digital Health Tools in Belgium and France” during the congress. This presentation will highlight key findings from our research into the evolving landscape of reimbursement policies for digital health technologies in Belgium and France. We aim to provide a clear understanding of the criteria and processes involved, helping stakeholders navigate the complexities of market access for innovative health solutions.

We look forward to connecting with industry leaders and exploring the latest trends and innovations in healthcare.

If you’d like to meet with us at the event, feel free to reach out to our co-founders Barbara D’haene or Nathalie Niclaus!

Event Details:

📅 Date: 5 and 6 March 2025
🌐 Location: RAI Congress Centre, Amsterdam, The Netherlands

LIVV attended the Clinical trials forum organised by pharma.be where following topics were discussed:

EFPIA-IQVIA Report: Katarina Nedog presented a report showing Europe’s declining share of global clinical trials (from 25% in 2013 to 19% in 2023), stressing the need for stronger European collaboration to remain competitive.

Belgian Clinical Trials Impact: Nathalie Lambot (pharma.be) and Tessa Van Montfort (Deloitte) presented Deloitte’s annual “Footprint of Clinical Trials in Belgium” study, showing Belgium’s stable growth and the importance of accelerating phase 1 studies.

Collaboration with Regulatory Authorities: Discussions with Hugues Malonne (FAGG) and Rainer Becker (European Commission) emphasized strengthening multinational trials, speeding up phase 1 studies, and fostering collaboration through European initiatives.

Belgian Clinical Research Initiatives: Dr. Levi Hoste presented the Belgian Paediatric Clinical Research Network, and Yven Van Herrewege discussed the Clinical Trial Center at the Tropical Institute of Antwerp, both enhancing clinical research and preparedness.

Future Workforce in Clinical Trials: A panel discussion highlighted the need for new skills in digitalization, data science, and specialized training to support future clinical trials in Belgium.

Event Details:

📅 Date: 22 January 2025
🕒 Time: 2.30 PM (CET)
🌐 Location: Palais des Académies, Rue Ducale 1, 1000 Brussels

Join us for an engaging and insightful webinar on the go-to-market strategies for digital medical devices, led by Barbara D’haene, a seasoned expert in the field.

The digital health landscape is rapidly evolving, and navigating commercialization pathways is critical for building viable, impactful businesses. In this presentation, we will dive into:

• Diverse commercialization approaches: Direct-to-Consumer (D2C), partnerships with pharmaceutical companies, and employer-driven channels.
• Key dynamics in the EU: Insights into regulatory, clinical, and market considerations shaping DTx success.
• Country-specific pathway: A closer look at France’s PECAN model for reimbursement.

This webinar is a must-attend for innovators, healthcare professionals, and business leaders looking to succeed in the burgeoning digital therapeutics space.

📅 Date: 23 January 2025
🕒 Time: 2PM – 2.45 PM (CET)
🌐 Location: Online

LIVV will attend the EFPIA Conference 2024, an influential event that will shape the future of healthcare in Europe.

📅 Date: 10 December 2024
📍 Location: Albert Hall, Brussels

Under the theme “IMAGINE a Healthier, More Competitive Europe,” this conference will bring together leaders from the pharmaceutical industry, policymakers, patient advocates, and healthcare experts to discuss:

• How Europe can become the go-to location for research, development, and manufacturing of new diagnostics, treatments, and vaccines
• Ways to accelerate equitable access to medicines
• The revolutionary impact of AI in health research

The event builds on the urgent call from Mario Draghi to help Europe regain its competitive edge and aligns with President von der Leyen’s vision for a robust Life Sciences strategy.

As a dedicated advocate for healthcare innovation and improved market access, LIVV looks forward to engaging in these critical discussions and exploring pathways to transform ambitions into action.

Join us as we work together towards a healthier, more competitive Europe.

For more details about the event, visit the official EFPIA website.

LIVV participated as an exhibitor at the Ophthalmologica Belgica Congress in Brussels, a leading event for ophthalmology professionals.

The congress provided a platform to connect with Key Opinion Leaders and pharma companies, stay informed about cutting-edge medical technologies in the field, share insights, and broaden our expertise in ophthalmology.

By engaging with numerous specialists and organizations, we strengthened our visibility in the field while expanding our network and knowledge.

For more details about the event, visit the official OB 2024 page.

Join us for an engaging and insightful webinar on the go-to-market strategies for digital medical devices, led by Barbara D’haene, a seasoned expert in the field.

The digital health landscape is rapidly evolving, and navigating commercialization pathways is critical for building viable, impactful businesses. In this presentation, we will dive into:

• Diverse commercialization approaches: Direct-to-Consumer (D2C), partnerships with pharmaceutical companies, and employer-driven channels.
• Key dynamics in the EU: Insights into regulatory, clinical, and market considerations shaping DTx success.
• Country-specific pathway: A closer look at France’s PECAN model for reimbursement.

This webinar is a must-attend for innovators, healthcare professionals, and business leaders looking to succeed in the burgeoning digital therapeutics space.

📅 Date: 12 December 2024
🕒 Time: 2PM – 2.45 PM (CET)
🌐 Location: Online

Seats were limited — Webinar is fully booked. But we are organizing a new session on 23 January 2025.

LIVV will attend ISPOR 2024 with Poster Presentation on Digital Health Reimbursement Criteria

We are excited to announce that LIVV will be participating in the upcoming ISPOR Europe 2024 conference, held in Barcelona from November 17th to 20th. As one of the leading global events for health economics and outcomes research (HEOR), ISPOR offers a unique opportunity for industry experts to exchange knowledge, insights, and best practices shaping the future of healthcare.

About our poster:

Our team will be presenting a poster titled “Visualizing Reimbursement Criteria for Digital Health Tools in Belgium and France” during the conference. This presentation will highlight key findings from our research into the evolving landscape of reimbursement policies for digital health technologies in Belgium and France. We aim to provide a clear understanding of the criteria and processes involved, helping stakeholders navigate the complexities of market access for innovative health solutions.

About the event:

17 – 20 November 2024
Barcelona International Convention Center
Placa de Willy Brandt, 11-14, 08019
Barcelona, Spain

We look forward to connecting with fellow attendees and sharing our experience in Market Access. If you’re attending ISPOR, be sure to visit our poster session to learn more!

Artificial Intelligence in Clinical Trials

LIVV was invited to present the topic “Artificial Intelligence in Clinical Trials” at Knowledge 2 Connect.

About our presentation:

“Artificial Intelligence in Clinical trials”, Barbara D’haene & Nathalie Niclaus

In this presentation, we explore how AI is transforming the clinical trial landscape, from enhancing protocol design and streamlining patient adherence to leveraging predictive analytics and improving outcome assessments. Our session provides a comprehensive overview of how AI is revolutionizing clinical trials.
We use specific examples to illustrate these AI trends in clinical trials.

About the event:

11 October, 12.00-13.30
Knowledge 2 Connect

UZ Ghent De Pintelaan, 9000 Gent

Knowledge 2 Connect is a program facilitated by the Knowledge Centre for Health Ghent. Annually, the knowledge centre hosts five Knowledge 2 Connect seminars to support researchers. The focus is based on providing customized information and exchanging best practices. The seminars are practice oriented and tailored to researchers who perform research in the area of medicine and health.

Barbara D’haene from LIVV Confirmed as Speaker at “Novel Business Models for Digital Health Trends”

The SAVE DATA project hosts a seminar on developing business models for digital health and sharable data spaces.

About our presentation:

“Go-to-market for digital therapeutics”, Barbara D’haene

In the rapidly evolving field of digital therapeutics (DTx), navigating the go-to-market (GTM) landscape is key to create commercially viable businesses. This talk will explore several commercialization pathways, including direct-to-consumer (D2C), pharmaceutical partnerships, and employer channels, while considering the regulatory, clinical, and market dynamics in the EU.  We will also explore the national pathways in Germany (DiGa) and France (PECAN). 

This presentation aims to provide a comprehensive overview of how DTx companies can leverage these strategies to achieve market penetration and scalability in a diverse regulatory environment like the EU, while addressing challenges such as evidence generation, reimbursement, and regional variations.

About the event:

10 October, 12.00-17.30
KAVA Congress Center
Consciencestraat 41, Antwerp

Full program: see website SAVE DATA project

Digital health and sharable data spaces are broad terms that apply to an infinite number of potential applications. They utilize innovative business models to leverage technology and data for value creation, addressing the unique needs of their respective markets. But how do you determine which business model is right for your needs?

From fee-for-service, value-based care, direct primary care and beyond … there are so many business models to consider and many factors to take into account before determining which models might work for your innovation. Novel Business Models will go over these factors and some of the business models that might apply to your unique situation.

 “Health on Stage.be” a national matchmaking event

Lifetech.brussels, MEDVIA, and BioWin organise “Health on Stage.be,” a national matchmaking event co-created with more than 25 Belgian healthcare organisations.

Venue : DoubleTree by Hilton, 3 rue Gineste, 1210 Brussels
Date : September 19, 2024

This event aims to strengthen ties between healthcare organisations and the HealthTech actors in Belgium. It offers a platform for Belgian hospitals (academic or not) and healthcare providers to present their needs to potential solution providers.

Augmenting Health Data Using AI

We will be attending this seminar on the opportunities and challenges involved in implementing and sustaining AI applications to secure health data. This workshop is hosted by SAVE DATA, one of VLAIO’s Coock projects. SAVE DATA, a collaboration among Vito, imec and MEDVIA, works with companies, non-profits, governments and knowledge institutions to make health pathways – both preventive and curative – more accessible in a safe, ethical and transparent manner.

Info about the event on the MEDVIA website.

Flanders AI Forum

Info about the event on the official webpage.

beMedTech Connect launch event

Info about the event on the beMedTech website.

Lunch & Learn: technologie voor werkbaar werk in de gezondheidszorg

Integrating industry 4.0 applications is not only more efficient, it also improves staff working conditions. Think: robot-controlled surgery, real-time patient monitoring and customized medical devices via advanced production techniques such as 3D printing.

Flanders Make, the strategic research center for the manufacturing industry, supports healthcare organization in transforming to more efficient and faster healthcare through breakthrough technologies.

The Summit at FTI Gent

Another inspiring day at The Summit – FTI Ghent. A two-day conference that takes innovators on a journey through the awesome world of health and bio tech

Particularly enjoyed the session ‘Data, AI and Ethics in Bio-Tech – by Frederik Coppens, Magali Feys & Steven Latré.’

inspire health&care at Flanders Expo Gent

Both Barbara D’haene and Nathalie Niclaus are present at Inspire Health & Care. We explored innovative solutions and collaborations that can drive forward health and care services.

FTI Gent – The EXPO in the Wintercircus Ghent

The LIVV company journey begins with momentum, we attend several tech events in one week starting with a visit to The Expo by ArcelorMittal in the Wintercircus Ghent. It takes visitors on a magical ride along all floors and corners of the former circus building (and vintage cemetery). For the first and last time.

The Wintercircus Ghent will be bringing together the brightest minds in Entrepreneurship, Technology and innovation.

‘Is AI making healthcare better?’ by Tom Braekeleirs

Nathalie Niclaus and Barbara D’haene attend the inpiring keynote by Tom Braekeleirs ‘Is AI making healthcare better?’ Diving into the transformative power of AI in the healthcare sector at Bank van Breda.