Norberta Balaisyte

📢 Join our virtual seminars series: Hot in Healthcare Discover the latest trends in healthcare and life sciences with our “Hot in Healthcare” virtual seminars series 2024/2025. We are excited to discuss with you key trends, innovations, and new regulations in Europe and beyond that are shaping the industry.   From the transformative European Health Data Space to deal-making, licensing, regulatory changes, and supply chain challenges, learn how we support our clients in building sustainable businesses and staying ahead of the curve, all while contributing to a healthier system.   Starting with three sessions from 24 September to 26 November 2024, our Baker McKenzie partners Julia Braun, LL.M. (M&A), Jan Kresken, LL.M. (Norwich) (Competition), Dr. Michaela Nebel (geb. Weigl) (Data Privacy), Frank Pflueger (Healthcare), and Dr. Anika Schürmann, LL.M. (Compliance/White-Collar Crime) are looking forward to your participation and lively discussions.   Don’t miss out - register now for one or more sessions and be at the forefront of healthcare’s evolution! 🚀 https://lnkd.in/ezAjyNK3     24 September 2024 | 12.00 - 12.45 pm CET  💡 European Health Data Space (EHDS) and German Health Data Use Act (GDNG) ▪ Status of legislation ▪ Key features ▪ Impact on pharma and med-tech companies ▪ Opportunities for access to electronic health data ▪ Need for protection of confidential business data and IP ▪ How to get prepared Session will be presented in English by Frank Pflueger (Healthcare) and Dr. Michaela Nebel (geb. Weigl) (Data Privacy).   Session 2: 5 November 2024 | 12.00 - 12.45 pm CET 💡 Current Trends in Dealmaking and Merger Control in the Healthcare Space ▪ Healthcare M&A dealmaking trends ▪ Fundraising ▪ Carve-Out & Spin-Out ▪ Patent Cliff ▪ Merger control filing requirements and the new transaction value threshold in Germany ▪ Recent ECJ Decision (Ilumina/Grail) ▪ New developments regarding the merger control assessment of healthcare deals   Session will be presented in English by Julia Braun, LL.M. (M&A) and Jan Kresken, LL.M. (Norwich) (Competition).   26 November 2024 | 12.00 - 12.45 pm CET 💡 Was tun bei behördlicher Bußgeldandrohung wegen angeschuldigter Verstöße gegen Arzneimittel- oder Medizinprodukterecht? ▪ Risikobehaftete geschäftliche Tätigkeiten ▪ Ahndung als Straftat oder Ordnungswidrigkeit ▪ Wer haftet (Unternehmen oder Geschäftsführung)? ▪ Verteidigungsstrategien (konfrontativ oder konziliant) ▪ "Deals" ▪ Sanktionen   Session will be presented in German by Dr. Anika Schürmann, LL.M. (Compliance/White-Collar Crime) and Frank Pflueger (Healthcare).   #BakerMcKenzie #Healthcare #LifeSciences #Innovation #Webinar #Sustainability #Regulations #SupplyChain #EHDS #GDNG

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As you might know, all Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements. ✔️📄 In this blog post, we delve into the Digital Therapeutics regulations of Belgium and France, focusing on their reimbursement strategies and providing a glimpse into how other EU member states fare in comparison. 👉 https://hubs.li/Q02KW-Yf0 #DigitalTherapeutics #DTx #RegulatoryAffairs #CEMarking

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🌐 𝗧𝗵𝗲 𝗥𝗶𝘀𝗲 𝗼𝗳 𝗧𝗲𝗹𝗲𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝗶𝗻 𝗘𝘂𝗿𝗼𝗽𝗲: 𝗔 𝗚𝗮𝗺𝗲-𝗖𝗵𝗮𝗻𝗴𝗲𝗿 𝗳𝗼𝗿 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 🏥💻 The COVID-19 pandemic has catapulted telemedicine into the global spotlight, revolutionizing the way we access healthcare services. 🚀🔬 In Europe, the integration of telemedicine into traditional healthcare systems has emerged as a promising solution to address various challenges faced by patients and healthcare providers alike. 🌍✨ With the power of technology, telemedicine offers a lifeline to those who struggle with geographical barriers, limited mobility, or even long waiting times. 🏞️🚗 By facilitating remote consultations, telemedicine not only enhances access to healthcare services but also improves the efficiency of medical professionals. 📲💙 Imagine a world where patients can connect with doctors from the comfort of their own homes, avoiding unnecessary travel, and reducing the burden on physical healthcare facilities. 🏡🌈 Moreover, the incorporation of telemedicine can alleviate the strain on healthcare systems, making it easier to manage emergencies, chronic conditions, and routine check-ups. 🩺⚕️ As we navigate the challenges brought on by the pandemic, it's clear that telemedicine is here to stay. It has proven its value in delivering quality healthcare remotely, ensuring that no one is left behind on their journey towards wellness. 🌟👥 Let's embrace the power of telemedicine and revolutionize healthcare together. 💪🌐 🔗 https://lnkd.in/gz6xrbUg #Telemedicine #HealthcareInnovation #DigitalHealth #AccessibleCare #FutureOfHealthcare #COVID19Response #EuropeanHealthcare #HealthcareRevolution #TechnologyInMedicine #HealthcareAccessibility #EfficiencyInHealthcare #COVID19Impact #TransformingHealthcare

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Joint Clinical Assessment (JCA) is a central component of the new European Union health technology assessment (EU HTA) Regulation, which will streamline HTA across EU member states and play a major role in bringing new medical technology to market. In our whitepaper Lumanity experts explore the challenges of JCA, with particular focus on oncology, rare disease and advanced therapy medicinal products (ATMPs). https://buff.ly/45mgJE6 #LumanityPerspectives #HTA #JCA #HEOR #EUHTA

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Joint Clinical Assessment (JCA) is a central component of the new European Union health technology assessment (EU HTA) Regulation, which will streamline HTA across EU member states and play a major role in bringing new medical technology to market. In our whitepaper Lumanity experts explore the challenges of JCA, with particular focus on oncology, rare disease and advanced therapy medicinal products (ATMPs). https://buff.ly/3YQtCF5 #LumanityPerspectives #HTA #JCA #HEOR #EUHTA

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Why have your clinical teams or sites focused on sourcing and procuring #ancillarysupplies for your #clinicaltrials? Consult with Ancillare to be your one source for all your Clinical Trial Ancillary Supply and Equipment needs. Contact us today https://www.ancillare.com/ #clinicalsupplychain #ancillarysupply #clinicaloutsourcing #clincialsupplies #ClinicalTrialSupply

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- Streamlining Healthcare Innovation with Europe’s Joint Clinical Assessment (JCA) - Discover how the Joint Clinical Assessment is transforming Health Technology Assessment across Europe in our latest blog post. JCA harmonizes the evaluation of new health technologies, enhancing access and ensuring equitable healthcare outcomes across member states. Key Benefits of JCA: • Standardized assessment processes. • Faster access to innovative treatments. • Significant cost savings through collaborative evaluations. Learn more about how JCA is shaping the future of healthcare in Europe and driving improved patient care. https://bit.ly/3WA4nnV #HEOR #reimbursement #costeffectiveness #pharmaceuticals #HTA #marketacces #HealthEconomics

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👩‍⚕️ Looking to safeguard your company against healthcare frauds and potential risks? Conduct a Royal Dutch Medical Association check with Validata.   ✔ By conducting this screening, you will ensure that all medical specialists meet the Dutch requirements within the healthcare sector.  But it is not just about meeting requirements; it's about safeguarding the integrity of your medical practice. With Validata's RDMA check, you can streamline the process and ensure every aspect of your organisation aligns with the standards.    🏥 Whether you are an employer in a hospital, clinic, or medical institution, our tailored approach ensures that RDMA checks are conducted efficiently and effectively, leaving you with peace of mind to focus on what truly matters: providing top-notch care to your patients.   👉 Ready to elevate your organisation's standards? Read more about the RDMA check here: https://lnkd.in/dM4Niisp

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𝐀𝐫𝐞 𝐲𝐨𝐮 𝐟𝐮𝐥𝐥𝐲 𝐬𝐚𝐭𝐢𝐬𝐟𝐢𝐞𝐝 𝐰𝐢𝐭𝐡 𝐲𝐨𝐮𝐫 𝐜𝐮𝐫𝐫𝐞𝐧𝐭 𝐞𝐂𝐎𝐀 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧 𝐨𝐫 𝐚𝐫𝐞 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐢𝐧𝐠 𝐚𝐝𝐨𝐩𝐭𝐢𝐧𝐠 𝐞𝐂𝐎𝐀 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐟𝐢𝐫𝐬𝐭 𝐭𝐢𝐦𝐞?   Having the right Electronic Clinical Outcome Assessment (eCOA) solution is paramount. It's not just about ticking boxes; it's about ensuring data accuracy, patient engagement, and operational efficiency.   At Your Research, we understand the challenges researchers face in selecting the perfect eCOA solution. That's why we're inviting you to pause and reconsider your current approach.    Take a moment to explore what eCOA Excellence truly means with Your Research. Our comprehensive suite of solutions is designed to elevate your clinical trials, offering reliability, seamless integration, and unparalleled support.   Discover how our innovative eCOA solutions can transform your research endeavours. Click the link to learn more:   https://lnkd.in/dVi-jyku   Don't settle for mediocrity when excellence is within reach.  #ClinicalResearch #eCOA #Innovation #YourResearch #Excellence  

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The business growth of the health sector goes hand in hand with a proper scientific communication strategy. However, its value is often underestimated and not prioritized in decision-making. Not only is it important to convey medical advances to other scientific peers, the visibility of the work also brings 𝗻𝘂𝗺𝗲𝗿𝗼𝘂𝘀 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀: - Developing a 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝗶𝗱𝗲𝗻𝘁𝗶𝘁𝘆 is essential for public perception of it. - 𝗗𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁𝗶𝗮𝘁𝗶𝗻𝗴 opens new collaboration opportunities in a competitive market. - Being recognized as a 𝗿𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲 in the sector attracts potential leads. - 𝗛𝗲𝗹𝗽𝗶𝗻𝗴 𝗽𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 𝗮𝗻𝗱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 benefit from these advancements. However, establishing an appropriate strategy for your company's communication is not easy. You must choose content relevant to your audience and adjust to regulations and good practice codes. Not everything is acceptable when it comes to health. To assist you, we have resolved the 𝗺𝗼𝘀𝘁 𝗳𝗿𝗲𝗾𝘂𝗲𝗻𝘁 𝗱𝗼𝘂𝗯𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗤&𝗔 of the carousel. 👇🏻 Do you know of other benefits or limitations? We love to learn. Do you have more doubts? Leave us your comments. #MedicalWriting #MedComms #MedCommsAgency #ComunicaCiencia #Salud #Medicina #Biomedicina #Investigacion #HealthcareMarketing #MedicalCopywriting

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How are mental health and pharmacists connected? 🧠💊 Mental health issues still carry stigma, often keeping discussions in the shadows. In honour of European Health Week, our latest #blog reveals the crucial role pharmacists play in preventing and monitoring these modern health challenges. We also explore how automation, while not in front, has an important part. Read on to learn how pharmacists support mental health, one patient at a time. 🌱 👇 https://lnkd.in/gmn6g2wP #MentalHealth #prevention #pharmacists #automation

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#FAQ In this series, employees of the Project Office Einstein Telescope - EMR answer frequently asked questions. Today's question is: 𝗪𝗵𝗼 𝘄𝗶𝗹𝗹 𝗳𝘂𝗻𝗱 𝘁𝗵𝗲 𝗘𝗶𝗻𝘀𝘁𝗲𝗶𝗻 𝗧𝗲𝗹𝗲𝘀𝗰𝗼𝗽𝗲? Stan Bentvelsen, director: "That is a very good question. The candidacy is primarily the responsibility of the participating countries, in our case, Belgium, the Netherlands, and Germany. At the European level, agreements are made by ministries regarding the organization and funding. The construction costs of the Einstein Telescope were estimated at 2 billion euros in 2021. The Dutch government reserved about 1 billion euros from the National Growth Fund in 2022 for preparations and construction. The German state of North Rhine-Westphalia has expressed its willingness to contribute financially, provided the German government in Berlin approves the project. A decision still needs to be made in Belgium. After construction, the operation phase will begin, which is expected to last 50 years. How the operating costs, amounting to 40 million euros annually, will be divided and what contributions are expected from other participating countries is not yet clear." More FAQ's: 🇬🇧 https://lnkd.in/eGw82HrM 🇳🇱 https://lnkd.in/eQbai2D7 🇫🇷 https://lnkd.in/eM66Wbj5 🇩🇪 https://lnkd.in/eJ-TTCqM   #EinsteinTelescope

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🔴 LIVE from Advanced Therapies in Belgium! We are excited to connect with industry peers in #clinicaltrials and discuss the latest advancements in innovative therapies for #patients! Reach out if you haven't had a chance to talk to our experts today: [email protected] and explore how we can help to ensure your clinical trial submissions! #biometrics #cro #clinicaldatamanagement #biostatistics #innovation #treatment #therapies

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🤣 𝐌𝐞, 𝐞𝐯𝐞𝐫𝐲 𝐭𝐢𝐦𝐞 𝐭𝐡𝐞 𝐧𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐛𝐨𝐝𝐲 𝐚𝐬𝐤𝐬 𝐟𝐨𝐫 '𝐣𝐮𝐬𝐭 𝐨𝐧𝐞 𝐦𝐨𝐫𝐞 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭 🤣 It always feels like the compliance process is never-ending! But staying ahead of those requests is crucial to ensuring your medical device reaches the market smoothly. Keeping your documentation well-organized (and easily accessible) can save you a lot of time—and stress. How do you manage the endless stream of regulatory requirements? Drop your tips in the comments below! ⬇️ #MedicalDevices #Compliance #RegulatoryAffairs #NotifiedBody #CECertification

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🌎 What do European Healthtech companies need for stateside success? The US market has long been considered the ‘Holy Grail’ for European HealthTech. After Series A, US expansion is often the next step – but despite the great opportunities this territory offers, without the right preparation and resources European businesses that are successfully domestically can struggle across the pond. Cristian Owen, our Senior Consultant and Digital Health specialist, has helped more than a few companies scale from Europe to the US. In this mini guide for digital health businesses thinking about crossing the Atlantic, you can find out how to approach topics such as value proposition, patient journey, and the FDA approval process, among others. Read on to find out more! #healthtech #digitalhealth #lifesciences #talent #insight #healthcare

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Want to accelerate your digital health innovation and forge valuable partnerships? Explore an open call, a special deal, and a help request - on R2GConnect.com! 💥 #OpenCall: Are you interested in developing a digital solution to improve medication management, partner with a European hospital, and secure €50,000 in funding? ⏰ ACT NOW! Only 3 days left to apply!  Here's an opportunity to collaborate and pilot a digital solution for medication safety within the #PlasticSurgery and #Burns department alongside a leading SME. Receive expert support in #business modeling, market insights, and access to valuable #networks and #resources. Partner with Centro Hospitalar e Universitário de Coimbra (CHUC) in addressing the #RecoMed challenge through the HealthChain I3 project co-funded by the European Commission. Ticbiomed 🕒 Don't miss out! 🔗 Apply by August 5th, 2024 on R2GConnect.com: https://bit.ly/3RMbl7G 🤝 Exclusive deal: xCARE (Cross Care) - Bringing medical products to people Are you considering expanding into the Japanese market? Join xCARE for a ✔️ Japan Free #MarketAccess & Accelerated #ProductDevelopment Workshop Deadline: August 31st, 2024 📌 Grab the deal: https://bit.ly/4aqGLH0 💡 Help Request: SurgiQ - Makes healthcare planning simpler! SurgiQ's team is looking for connections with #hospitals, either directly or through integration partners, outside Italy, who are interested in adding #AI-based, automatic planning to their offerings. #Investment proposals in equity or quasi-equity can be considered. Can you help connect them with potential partners? 📌 Offer your support: https://bit.ly/3Y8ZKTW 🌍 Unlock more collaboration opportunities and foster growth with R2GConnect.com! R2GConnect facilitates digital health #partnerships, connecting innovative #startups with key players like #Insurances, #Investors, #Pharma, #ServiceProviders, and more! If you are curious about how you can best use the platform, book a demo session with Sorin STIRCU, Partnerships Manager: https://bit.ly/3TGL2kF #digitalhealth #globalhealth #healthcare #partnershipopportunities #marketentry #specialdeals #startuprequests #opencalls #innovationmanagement

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Ever wondered why your doctor can't easily access your health records from another clinic or country? It's all about interoperability! 🔄 What is Interoperability? 👀 Simply put, it's the ability of different healthcare systems to share and understand data. Think of it as ensuring your health info flows seamlessly between doctors, hospitals, and even across borders. 🇪🇺The European Health Data Space (EHDS): Europe is stepping up with EHDS to: 📏 Set clear rules and standards for data sharing. 🛠️ Build the tech to make sure your health info is safe and accessible. 🤝 Bring everyone together for smarter healthcare solutions. Recent Developments: At a recent digital health workshop, industry leaders like Leyr, EPIC, Oracle, Philips, and Siemens showcased their tech to improve data sharing. From simplifying access to health records to securing data exchange, these innovations are paving the way for a connected health future. Here's what Alper Tanrıverdi, Ginevra Santini and Nathan da Silva Carvalho (DIGITALEUROPE) had to say: https://lnkd.in/etTAU5Yy #HealthTech #DigitalHealth #Interoperability #EHDS #Innovation #FutureOfHealthcare #XpanDH

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The global healthcare sector is facing significant challenges. In Europe, we are experiencing rising costs, an aging population, and increasing demand for advanced digital solutions. 🏥 Trifork is dedicated to addressing these issues head-on. As an IT and business service provider with a commitment to sustainability, they engage both the public and private healthcare sectors. 💊 Their work spans hospitals, general practitioners, pharmacies, homecare services, and multinational pharmaceutical companies. As Julian Springer, Senior Business Developer at Trifork, explains, their innovative digital health solutions aim to simplify life for both patients and healthcare workers. By bridging gaps across various sectors, they empower patients to manage their health journeys and ensure seamless communication between healthcare providers and their patients across different departments. 📢 Find our how Trifork can help you drive the future of healthcare with technology and innovation: https://lnkd.in/dH_HydeG #HealthTech #DigitalHealth #PatientEmpowerment

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