Clinigen’s Post

It will be exiting to follow the work of Martin Jakobsson and his team at TÜV SÜD, with Their newly established role as the first Danish MDR Notified Body is a significant milestone for Denmark’s life-science ecosystem.. The absence of a notified body in Denmark has been a major roadblock, hindering the flourishing of our dynamic medtech scene and overall value creation. Start-ups and small to medium enterprises (SMEs) have felt the impact. Historically, this situation has made Denmark and the EU a less attractive market for life science, prompting companies to explore other countries and geographies. At Contura International A/S , we’ve witnessed this firsthand. Life science contributes to over 20% of Danish exports, but the rigide 2017 MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) regulations in the EU have adversely affected growth rates and the number of patents filed according to Medicoindustrien. Calling for a more flexible and pragmatic approach to fortify our ecosystem With TÜV SÜD’s expertise and commitment, we’re optimistic that this new Notified Body will pave the way for innovative medical devices to swiftly enter the European market. Let’s strengthen our life-science landscape and foster more groundbreaking advancements.

Developing an iPSC-based therapeutic product? Come join the roundtable discussion on 'Sourcing and Regulation with your iPSC Therapeutic' at Advanced Therapies Europe at Estoril, Portugal 5th-7th September 2023. (https://lnkd.in/e6Fnadte).

As personalized medicine gains prominence and the demand for valid and successful external control arms (ECA) grows, it is crucial to discuss the challenges and approaches to harmonizing multiple real-world data sources for ECA creation. The challenges and opportunities around this topic will be delved into at a Spotlight session on 13 November during ISPOR Europe 2023, Copenhagen, Denmark. https://ow.ly/A2zy50PVNMV

Dear Connections 😃, Is there an increase in awareness of reading the labels beyond the lines? 🤔 Why is it important to have your own scientifically backed health claims? 😮 Are these questions buzzing around you? 🤷♂️ Let us discuss more at Food ingredients Europe at your booth 💬. Let's make an impact together for your unique product.🤝 #Clinicaltrials #foryou #forgrowth

📢Following the launch of the pan-European Health Outcomes Observatory, we are thrilled to introduce the newly appointed members of the Board. Congratulations to: 🔹 Dr Jørgen Schøler Kristensen (Chairman of the Danish Medicines Council), who will serve as Chair 🔹 Dr Linetta Koppert (Dutch H2O), who will serve as Vice-Chair 🔹Andreas Christodoulou (European Patients' Forum Board Member), who will join the Board as Treasurer; and 🔹Board Members Dr Matthias Rose (German H2O), Dr Pilar Rodriguez Ledo (Spanish H2O), and Héctor Röthlisberger. This marks a significant milestone for the H2O initiative, now including the pan-European Observatory and national observatories in Austria, Germany, the Netherlands, and Spain. We are eager to expand further, promoting patient empowerment and advancing health research across #Europe and beyond. Read our press release on the launch of the pan-European Health Outcomes Observatory 👉 https://lnkd.in/eMnc8WTF Innovative Health Initiative (IHI), EFPIA - European Federation of Pharmaceutical Industries and Associations, European Patients' Forum, Trial Nation, JDRF International, Teamit #InnovativeHealthInitiative #HealthcareInnovation #DataAnalytics #HealthOutcomes #HealthResearch #DataDrivenHealthcare #InnovateHealth #HealthcareRevolution

HLTH Europe 2024: A Thriving Hub for European Healthcare (with a Norwegian Twist!) HLTH Europe 2024 wrapped up a highly successful first year, solidifying its position as a central meeting point for the European healthcare ecosystem. Over 3,400 attendees, including health systems/providers, health tech companies from across the globe, pharmaceutical giants, investors, and support networks, convened in Amsterdam for a packed program of conferences, networking events, and presentations. The conference boasted a truly international reach, with organizations from over 50 countries participating. This year, Norway was well-represented by innovative companies like Convene, Mode Sensors, Inform Life, Whereby, Deepinsight, DIPS, Kernel, and Myworkout. The pan-European focus and the energy from attendees set the stage for future growth, leaving many excited about the upcoming HLTH USA conference and the prospect of HLTH Europe becoming an annual event. The success of HLTH Europe underscores the strong demand for a truly international healthcare event in Europe, fostering collaboration and innovation across borders. #HLTHEurope #HealthcareInnovation #NorwayInHealthcare

At the meeting of our Healthcare Steering Committee with the ENEA Tech e Biomedical Foundation, we discussed the framework conditions for increasing investment in research and innovation in the biomedical and life sciences sector. As Camera di Commercio Italo-Germanica (AHK Italien) we represent around 15% of the Italian healthcare sector and with our companies we want to make a contribution to strengthening the Italian healthcare system. Our community of over 1,700 German companies in Italy is already the largest green field investor in Italy. In the current transformation scenario, the stimulation of investments and the promotion of innovative projects is of central importance for Italy and Germany, two very important countries for the resilience of Europe and the competitiveness of its production systems.

It is a dream come true; I know it sounds like a shallow soundbite, but it is anything but… 6 years ago I had such a dream. The dream of patients being in control of their data, being able to measure how they are doing in a way that is understood by healthcare providers and being able to be to part of any decision that affects their lives. Not out of pity or compassion; but because they have the data and the evidence to prove their point. 6 years ago the #EHDS was not even at the horizon; however there is a tremendous opportunity for synergies now. The Pan-European Observatory can serve as a forum to achieve consensus on what can be measured digitally in routine care in order to improve care and fuel the EHDS with standardized outcome data. At the same time, the data access framework developed through the H2O project offers a blueprint on how to manage data by relying on the Patient Agreement. H2O through the leadership of the Pan-European Health Outcomes Observatory can pave the way on how to build the EHDS on the foundation of 'Data Trusts' and multi-stakeholder consensus on what to measure and how.

The MTAA MedTech Conference is just around the corner! Expert Heyam Kalla will be discussing topical considerations around Regulatory Convergence and Harmonisation. If MedTech piques your interest, I encourage you to attend and ask questions. I am excited to see you there next week! #MTAA #MedTech #MedicalDevices #IVD #CompanionDiagnostics #SAMD