Medical Devices & Combination Products Development, Regulatory and Control

🌟 The 6th Drug-Device Combination Products Berlin 2024 (#VLDDCP) 🌟 brought together top professionals, visionary innovators, and key regulators from the healthcare and medtech industries. Together, we explored cutting-edge advancements, addressed major challenges, and shared the latest regulatory updates shaping the future of drug-device combination products. 🔸 Speakers – Your insightful presentations and expertise have sparked meaningful discussions and inspired innovation in the drug-device combination field: 🔹 Masterfully moderated by Paul Johnson I Johnson Consulting 🔹 Juan Martín Carriquiry I Beyond Conception GmbH 🔹 Javad Jabbari I Ascendis Pharma 🔹 Richard Kieran I West Pharmaceutical Services 🔹 Bernard Gauthier I Sanofi 🔹 Dr. Heather Johnson I Granzer Regulatory Consulting & Services GmbH 🔹 Dr. René Dathe, MBA, MBA I Novartis 🔹 Anne-Sofie Madsen Staples I Novo Nordisk 🔹 Bjarne Sørensen I Phillips Medisize 🔹 Will Denny I Sandoz 🔹 Kevin B. I UCB 🔹 Jakob Lange I Ypsomed AG 🔹 Horacio M. P. I Novo Nordisk 🔹 Yvonne Limpens I Emergo by UL 🔹 Patrice Becker I St Giles Medical 🔹 Michael Stapleton I Lohmann GmbH & Co. KG 🔸 Attendees – Thank you for joining us in Berlin! Your active participation and enthusiasm fostered a collaborative atmosphere that made this event truly special. 🔸 Partners & Sponsors – We are incredibly grateful for your support and contributions. Your involvement helped shape a dynamic and engaging event: ✨Haselmeier, a medmix Brand✨ haselmeier.com ✨West Pharmaceutical Services✨ westpharma.com ✨Granzer Regulatory Consulting & Services GmbH ✨ granzer.biz ✨Lohmann GmbH & Co. KG ✨https://lnkd.in/dzPaeFfc With insightful discussions, groundbreaking ideas, and valuable networking, #VLDDCP was the place to be for all shaping the future of patient-centered solutions. ☑️ Request presentation materials: #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗 https://lnkd.in/dV-UZJ4v ☑️ Explore upcoming summits 2025: 🔜11th Pre-Filled Syringes, Injection Devices & Parenteral Systems (#VLpfs) 🔗https://lnkd.in/dFsX32Hk 🔜5th MedAI Regulatory & Compliance (#vlmeddev) 🔗https://lnkd.in/d846Gpda ☑️ Get in touch regarding future partnerships at 📩 hello@vonlanthenevents.com & Milana Dreo Best regards, Vonlanthen Events ❤️ vonlanthenevents.com #drugdevicecombination #combinationproducts #drugdelivery #cgmp #spdf #connecteddevices #medicaldevices #compatibility #sustainability #digitalhealth #hfe #qsr #qmsr #autoinjector #injectors #medtech #ivd #drugdevelopment #ddss #humanfactor #samd #conference #summit #ivds #regulatory #cybersecurity #injectabledrugs #injectables #iso13485 #injectiondevices #materialscience #humanfactorengineering #innovation

💉 Join Us at #VLpfs 2025! Mark your calendar for the 11𝐭𝐡 𝐏𝐫𝐞-𝐅𝐢𝐥𝐥𝐞𝐝 𝐒𝐲𝐫𝐢𝐧𝐠𝐞𝐬, 𝐈𝐧𝐣𝐞𝐜𝐭𝐢𝐨𝐧 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 & 𝐏𝐚𝐫𝐞𝐧𝐭𝐞𝐫𝐚𝐥 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 Summit, happening 𝐀𝐩𝐫𝐢𝐥 2-3, 2025, in 𝐕𝐢𝐞𝐧𝐧𝐚, 𝐀𝐮𝐬𝐭𝐫𝐢𝐚! This is your opportunity to: ✅ Explore cutting-edge innovations in pharmaceuticals, medical devices, and combination products. ✅ Gain insights into the latest manufacturing advancements and regulatory updates. ✅ Connect with industry leaders, share expertise, and stay ahead of trends. Join us for 2 conference days full of networking! 🔗 Register now to get the best price: https://bit.ly/VLpfs #VLpfs2025 #Pharmaceuticals #MedicalDevices #Innovation

EU MDR / IVDR News!! (Team-NB) Team-NB has published a position paper and questionnaire regarding the applicability of Artificial Intelligence (AI) in medical devices under MDR and IVDR regulations. This questionnaire was prepared in accordance with MDGG 2022-14 requests. It is to be understood in the context of MDR and IVDR Regulations as well as MDCG guidance (MDSW). Specific requirements of the AI Regulation 2024/1689 have not been considered and will be part of a comprehensive revision which is to follow. However, it should be acknowledged, that there is a considerable overlap of requirements stated in the AI Regulation and the existing regulatory and standards framework for software and AI. This questionnaire follows the idea that the safety of AI-based medical devices can only be achieved through a process-oriented approach, whereby all relevant processes and phases of the life cycle must be considered. This questionnaire is jointly published by the German Notified Bodies Alliance for Medical Devices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IG-NB) and Team NB. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr #teamnb #ai

The 11th Pre-Filled Syringes I #VLpfs Vienna 2025 is the premier platform highlighting the latest innovations, manufacturing breakthroughs, and quality control advancements in the pharmaceutical, medical devices, and combination products industries. Join industry leaders to explore emerging trends, network with experts, and gain valuable insights that shape the future of the sector. #VLpfs 🔸11th Pre-Filled Syringes, Injection Devices & Parenteral Systems Summit🔸 📆April 2-3, 2025 📍 Vienna, Austria 🔗Register now : https://lnkd.in/d-eBgqSi The summit is proudly supported by ✨Gerresheimer✨ Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry.    The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.  Find more at gerresheimer.com/en/home  #combinationproducts #design #engineering #drugdelivery #compatibility #connecteddevices #digital #digitalhealth #DDSs #autoinjector #injectors #medtech #drugdevelopment #innovation #ssr #conference #CDMO #humanfactors #prefilled #prefilledsyringes #regulatory #sustainability #injectabledrugs #injectables #injectiondevices #PFS #HFE #ivd #syringe #materialscience #medicaldevices #contractmanufacturing #parenteral

EU MDR / IVDR News!! (Vigilance) The Medical Device Coordination Group (MDCG) has published a revised guidance regarding "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746" This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations. This document provides updates on the original document published in February 2023 and includes: • New questions added and alignment with IVDR throughout the document • Revised definitions for incidents and serious incidents • Updated flowchart for incident management • Field Safety Corrective Actions (FSCA) guidance added on actions taken in third countries and notification requirements across the EU. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr #pms

Happening now: the 6th Drug-Device Combination Products Conference (Vonlanthen Events) in Berlin! We’re eager to connect with fellow industry professionals – this event is a fantastic opportunity to share insights, explore new ideas, and discuss exciting collaborations in the drug-device field. If you’re attending, let’s meet up! Feel free to reach out or find us at the event: Klaus Ulrich Schmid & Stefanie Manger #Haselmeier #medmix #DrugDelivery #VLDDCP #CombinationProducts

▶️ Recent successful submissions of drug-device combination products: Lessons learnt and new horizons Join Kevin B., UCB and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience #drugdevicecombination #humanfactor #humanfactorengineering

Let’s connect via: skin / adhesives / devices / development ▶️ Lohmann value chain ▶️ Skin as a substrate ▶️ Stick to skin solutions ▶️ Critical factors for the design of wearables Join Michael Stapleton, Lohmann GmbH & Co. KG and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 The summit is proudly supported by ✨Lohmann GmbH & Co. KG ✨ As a leading manufacturer and converter of pressure-sensitive adhesives and component parts for wearable, ostomy, diagnostic, and other medical applications, Lohmann delivers comprehensive solutions and provides a complete value chain, minimizing risk and accelerating your medical device innovations to market. Find more at https://lnkd.in/dzPaeFfc The conference & expo aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #wearables #drugdevelopment #DDSs #innovation #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience #drugdevicecombination #humanfactor #humanfactorengineering

We are excited to welcome an incredible lineup of industry experts for the #VLDDCP 🌟 6th Drug-Device Combination Products Conference 🌟, taking place on October 15-16, 2024, in Berlin, Germany! 🔹 Paul Johnson I Johnson Consulting 🔹 Juan Martín Carriquiry I Beyond Conception GmbH 🔹 Javad Jabbari I Ascendis Pharma 🔹 Richard Kieran I West Pharmaceutical Services 🔹 Bernard Gauthier I Sanofi 🔹 Dr. Heather Johnson I Granzer Regulatory Consulting & Services GmbH 🔹 Dr. René Dathe, MBA I Novartis 🔹 Anne-Sofie Madsen Staples I Novo Nordisk 🔹 Bjarne Sørensen I Phillips Medisize 🔹 Will Denny I Sandoz 🔹 Kevin B. I UCB 🔹 Jakob Lange I Ypsomed AG 🔹 Horacio M. P. I Novo Nordisk 🔹 Yvonne Limpens I Emergo by UL 🔹 Patrice Becker I St Giles Medical 🔹 Michael Stapleton I Lohmann GmbH & Co. KG Join us as these respected speakers dive deep into the challenges and opportunities shaping the future of drug-device combination products. This is your chance to learn, engage, and drive innovation! #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/4cH86Xd The summit is proudly supported by ✨Haselmeier, a medmix Brand✨ haselmeier.com ✨West Pharmaceutical Services✨ westpharma.com ✨Granzer Regulatory Consulting & Services GmbH ✨ granzer.biz ✨Lohmann GmbH & Co. KG ✨https://lnkd.in/dzPaeFfc 📅 Mark your calendars – see you in Berlin! #drugdevicecombination #combinationproducts #drugdelivery #cgmp #spdf #connecteddevices #medicaldevices #compatibility #sustainability #digitalhealth #hfe #qsr #qmsr #autoinjector #injectors #medtech #ivd #drugdevelopment #ddss #humanfactor #samd #conference #summit #regulatory #cybersecurity #injectabledrugs #injectables #ivds #iso13485 #injectiondevices #materialscience #humanfactorengineering #innovation