regenold GmbH

𝗔𝘂𝗳 𝗱𝗲𝗿 𝗦𝘂𝗰𝗵𝗲 𝗻𝗮𝗰𝗵 𝗲𝗶𝗻𝗲𝗺 𝗝𝗼𝗯? 𝗖𝗵𝗲𝗰𝗸! Wir verstärken das regenold Team und suchen Dich als 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 (m/w/d) in Teilzeit: Weitere Details zur Stelle findest du unter: https://lnkd.in/eMxzehkr Mehr Karriere Möglichkeiten findest Du hier: https://lnkd.in/eWJ6FYjJ

Congratulations to the DTx Consulting Alliance, dtXca for their continued success in supporting and advancing digital health solutions! 🎉 At regenold GmbH, we are incredibly proud to be a member of this forward-thinking group of digital pioneers and we are excited to collaborate with all the dedicated members as we work together to shape the future of healthcare through innovative digital solutions. A warm and hearty welcome to Bornholdt Lee GmbH! Here's to many more milestones ahead! 🚀 #DigitalHealth, #DTx, #PharmaInnovation, #DiGA, #HealthcareInnovation

𝗝𝗼𝗶𝗻 𝘂𝘀 𝗮𝘁 𝘁𝗵𝗲 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 𝗶𝗻 𝗕𝗲𝗿𝗹𝗶𝗻! We’re thrilled to bring fresh insights to the evolving world of digital healthcare at this year’s Digital Health Conference on Thursday, November 28 in Berlin. As part of the DTx Consulting Alliance 𝗱𝘁𝗫𝗰𝗮, regenold GmbH is hosting a workshop: “𝗗𝗧𝘅 𝗯𝗲𝘆𝗼𝗻𝗱 𝗦𝘁𝗮𝗿𝘁𝘂𝗽𝘀, 𝗣𝗵𝗮𝗿𝗺𝗮 𝘁𝗮𝗸𝗲𝘀 𝗶𝘁 𝗮𝗹𝗹!” Germany’s DiGA market is transforming healthcare, opening doors for big pharma to drive innovation like never before. Our workshop will explore the key shifts that have enabled new opportunities for larger players and how this market evolution is shaping the future of digital therapeutics (DTx). 📍 Where: KOSMOS, Berlin 📅 When: Thursday, November 28 Don’t miss this opportunity to dive deep into the next big wave of digital healthcare! Check out the full program and plan your visit here: 👉 https://lnkd.in/dCeGgKrA Jonas Albert, Oliver Hilgers, Sebastian Cornelius Retter, Luisa Wasilewski See you in Berlin! #DigitalHealth, #DTx, #PharmaInnovation, #DiGA, #HealthcareInnovation

𝗪𝗲’𝗿𝗲 𝗵𝗲𝗿𝗲 𝗮𝘁 𝗠𝗲𝗱𝗶𝗰𝗮 𝗶𝗻 𝗗𝘂𝘀𝘀𝗲𝗹𝗱𝗼𝗿𝗳, 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗲𝗻𝗲𝗿𝗴𝘆 𝗶𝘀 𝗮𝗯𝘀𝗼𝗹𝘂𝘁𝗲𝗹𝘆 𝗶𝗻𝗰𝗿𝗲𝗱𝗶𝗯𝗹𝗲! We’re thrilled to connect with so many talented individuals and organizations, discovering first-hand the cutting-edge innovations reshaping healthcare. This conference is truly mind-blowing, and we’re inspired by the passion and progress we’re seeing! If you’re here, come by 𝗛𝗮𝗹𝗹𝗲 𝟭𝟯, 𝗕𝗼𝗼𝘁𝗵 𝗔𝟴𝟵 today to meet our regenold GmbH team! We’re eager to talk about everything from the latest DTx, DiGA, and DiPA advancements to transformative solutions in EU regulatory compliance, market access, and post-market surveillance. Looking forward to seeing you! #Medica2024, #MedicalDevice, #DigitalHealth, #MedTech, #HealthcareInnovation

𝗪𝗲'𝗿𝗲 𝗵𝗲𝗮𝗱𝗶𝗻𝗴 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗮 𝗶𝗻 𝗗𝘂𝘀𝘀𝗲𝗹𝗱𝗼𝗿𝗳! From November 11-14, the regenold GmbH team will be visiting 𝗠𝗲𝗱𝗶𝗰𝗮, the world-renowned Trade Fair for Medical Technology & Healthcare. We can't wait to connect with everyone in the industry—if you’re attending, reach out so we can set up a meeting! Thomas Haszprunar Oliver Hilgers Marcel Wöllbrink Tom Wood Following our recent collaboration at the DMEA in Berlin, we're delighted to be invited as guests by 𝗗𝗶𝗴𝗶𝗛𝗲𝗮𝗹𝘁𝗵𝗦𝘁𝗮𝗿𝘁.𝗡𝗥𝗪, our key partners in driving innovation in digital health for NRW. Join us on 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆, 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟭𝟯, 𝗮𝘁 𝘁𝗵𝗲 𝗡𝗥𝗪 𝗣𝗮𝘃𝗶𝗹𝗶𝗼𝗻 (𝗛𝗮𝗹𝗹 𝟭𝟯, 𝗕𝗼𝗼𝘁𝗵 𝗔𝟴𝟵) to explore ideas and catch up! See you there! 👋 #Medica2024, #MedicalDevice, #DigitalHealth, #MedTech, #HealthcareInnovation

𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗢𝘂𝗿 𝗡𝗲𝘄 𝗙𝗶𝘃𝗲-𝗣𝗮𝗿𝘁 𝗦𝗲𝗿𝗶𝗲𝘀: "𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲𝘁𝗶𝗺𝗲" We’re excited to launch the first instalment of our deep-dive series on the critical topic of 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲𝘁𝗶𝗺𝗲, prepared by our regulatory expert Huguette Tchamko. In 𝗣𝗮𝗿𝘁 𝟭 - 𝗔𝗻 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻, we’ll delve into the fundamentals of medical device lifetime, exploring what it is, what it isn't, and key factors involved in determining a device’s lifetime, including mechanical, biological, and clinical considerations. This series will provide valuable insights into how medical device manufacturers ensure their products remain safe, reliable, and effective throughout their intended use. 👉 Check out 𝗣𝗮𝗿𝘁 𝟭 of our series now, and stay tuned for the upcoming deep dives! #MedicalDevices, #Compliance, #MedTech, #HealthTech

𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗠𝗮𝘇𝗲: 𝗛𝗼𝘄 𝘁𝗼 𝗨𝗻𝗹𝗼𝗰𝗸 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 In the fast-evolving world of healthcare innovation, Drug-Device Combination Products (DDCPs) present incredible opportunities—but they also come with complex regulatory hurdles. With overlapping requirements from both pharmaceutical and medical device frameworks, bringing these products to market can feel like an unsolvable puzzle. At regenold GmbH, we take pride in being experts in navigating this maze. Our deep understanding of global regulations and our hands-on experience in guiding DDCPs to market make us the trusted partner you need. We streamline the entire process, minimizing delays and maximizing your product’s potential. 🔍 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗳𝗼𝗿 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲? https://lnkd.in/eQ_3nP9A We’ve just launched our 𝗢𝗻𝗹𝗶𝗻𝗲 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀, packed with key insights to help you tackle: • Working with Notified Bodies • Obligations concerning MDR, GMP requirements, and specific national laws • How to perform Post-market surveillance • Products not yet defined by existing frameworks …and much more! Check it out here: https://lnkd.in/eQ_3nP9A Don't let regulatory challenges slow down your innovation. 𝗢𝘂𝗿 𝘁𝗲𝗮𝗺 𝗶𝘀 𝗵𝗲𝗿𝗲 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘆𝗼𝘂, whether you’re looking for general advice or have specific product questions. Contact us or 𝗯𝗼𝗼𝗸 𝗮 𝗳𝗿𝗲𝗲 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 today: https://lnkd.in/eAF8seky #CombinationProducts, #DrugDelivery, #MDR, #MedTech, #MedicalDevices

𝗨𝗻𝗹𝗼𝗰𝗸 𝘁𝗵𝗲 𝗙𝘂𝗹𝗹 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗼𝗳 𝗬𝗼𝘂𝗿 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗗𝗶𝗚𝗔) Are you looking to bring your DiGA to market but unsure where to start? We've got you covered with our Guide to Digital Health Applications (DiGA)—a comprehensive resource for navigating the complex world of digital health. 🔍 𝗪𝗵𝗮𝘁'𝘀 𝗶𝗻𝘀𝗶𝗱𝗲? • Key insights into the DiGA framework and authorization conditions. • Answers to common questions like "What is a DiGA?" and "How does it differ from a medical device?" • Step-by-step guidance on getting your DiGA listed, including timelines and necessary documentation. • Pricing strategies and factors that influence your DiGA's value. • Information on regulatory requirements and clinical evidence needed for successful approval. 💡 𝗪𝗵𝘆 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗵𝗶𝘀 𝗴𝘂𝗶𝗱𝗲: Since the introduction of the Digital Healthcare Act (DVG), DiGAs have become an integral part of the healthcare system in Germany. But the path to market is intricate and demands a strategic approach. Our guide offers practical tips and expert insights to help you navigate this journey with confidence. 𝗡𝗲𝗲𝗱 𝗵𝗲𝗹𝗽? We don’t just offer information—we provide end-to-end support services, from regulatory strategy to clinical trials, ensuring your DiGA meets all the necessary requirements. 𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝘁𝗮𝗸𝗲 𝘆𝗼𝘂𝗿 𝗗𝗶𝗚𝗔 𝘁𝗼 𝘁𝗵𝗲 𝗻𝗲𝘅𝘁 𝗹𝗲𝘃𝗲𝗹? Visit our landing page and explore how we can support you in making your digital health application a success. 𝗖𝗵𝗲𝗰𝗸 𝗼𝘂𝘁 𝗼𝘂𝗿 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 (𝗗𝗶𝗚𝗔) 𝗵𝗲𝗿𝗲: https://lnkd.in/e2Tjnbrf #DiGA #DigitalHealth #HealthcareInnovation #HealthTech #MedicalDevices #RegulatoryCompliance #HealthApp Let’s bring your vision to life!

𝗘𝘃𝗲𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲: We are thrilled to announce that the 𝟵𝘁𝗵 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 𝗶𝗻 𝗕𝗲𝗿𝗹𝗶𝗻 𝗼𝗻 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟭𝟬 is now 𝗳𝘂𝗹𝗹𝘆 𝗯𝗼𝗼𝗸𝗲𝗱! 🙌 We want to extend a huge thank you to everyone who registered—your enthusiasm for shaping the future of healthcare is truly inspiring. As we countdown to this incredible event, we're particularly looking forward to our DTx Sidetrack: “𝗗𝗧𝘅: 𝗔 𝗝𝗼𝘂𝗿𝗻𝗲𝘆 𝗙𝗿𝗼𝗺 𝗩𝗶𝘀𝗶𝗼𝗻 𝘁𝗼 𝗦𝘂𝗰𝗰𝗲𝘀𝘀”. With an outstanding lineup of speakers and thought leaders, we're set to explore groundbreaking advancements in Digital Therapeutics and AI that are revolutionizing the healthcare landscape. We can't wait to engage with all the brilliant minds attending, dive deep into these critical conversations, and of course, network and unwind in true Berlin style. See you in Berlin soon! #DigitalHealth, #DTx, #AI, #HealthcareInnovation, #PharmaAI, #DigitalTransformation

𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲: 𝗡𝗲𝘄 𝗘𝗥𝗔 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗳𝗿𝗼𝗺 𝟭 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰 As of 1 September 2024, the revised Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use is officially in force. This update marks a significant step forward in aligning ERA requirements with the latest scientific knowledge and streamlining the approach to evaluating the environmental impact of human medicines. 𝗞𝗲𝘆 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲: • 𝗗𝘂𝗮𝗹 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁𝘀: In addition to the risk assessment, every medicinal product must now undergo a specific hazard assessment for Persistent, Bioaccumulative, and Toxic (PBT) properties. • 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗠𝗮𝗸𝗶𝗻𝗴: A new decision tree has been added to guide the Phase I risk assessment process. • 𝗘𝘅𝗽𝗮𝗻𝗱𝗲𝗱 𝗧𝗲𝘀𝘁𝗶𝗻𝗴: Phase II risk assessment requirements have been broadened, with mandatory tests now more comprehensive than before. • 𝗗𝗮𝘁𝗮 𝗦𝗲𝗮𝗿𝗰𝗵: Applicants must now provide a complete literature review for active substances already on the market. 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝗠𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘀𝗮𝘁𝗶𝗼𝗻: Applications submitted on or after 1 September 2024 must adhere to the revised guideline. With our extensive experience in environmental risk assessments and a proven track record in supporting drug development and marketing authorisation, we’re here to help you navigate these new requirements smoothly. 𝗡𝗲𝗲𝗱 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝗰𝗲? Contact us today to ensure your compliance and successful market access: https://lnkd.in/ef9Cdf8R #Healthcare, #Compliance, #RegulatoryAffairs, #MarketAccess, #GlobalHealth