Medical Devices & Combination Products Development, Regulatory and Control’s Post

We are thrilled to announce that Kevin Brunet, Head of Devices Development and Primary Packaging Quality at UCB, will be speaking at the 6th Drug-Device Combination Products conference on October 15-16, 2024, in Berlin, Germany. With over 12 years of experience in the development and manufacturing of medical devices and drug-device combination products, Kevin has built a robust expertise across various functions, including R&D, supply chain, operations, and quality. His key strengths lie in design and development, risk management, and supplier audits and management, with a proven track record of bringing innovative products to approval and launch, including navigating N.B. audits and H.A. inspections. #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 #combinationproducts #design #engineering #drugdelivery #digital #connecteddevices #medicaldevices #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #DDSs #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #injectabledrugs #injectables #injectiondevices #digital #drugdevicecombination #humanfactor #humanfactorengineering

Combinations for customers in context ▶️Knowing your customers, including their needs and wants ▶️Quality target product profile ▶️Brilliant products in a real-world context ▶️Innovation: What's out there and how you can engage with it Join Paul Johnson, Paul Johnson Consulting Limited 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 #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

With over two decades of experience in the pharmaceutical industry, Paul Johnson stands as a key independent consultant specializing in the CMC (Chemistry, Manufacturing, and Controls) aspects of NCE and generic inhaled product development. Since 2018, Paul has provided invaluable insights and expertise to a diverse range of clients, including large and small pharma companies, pharmaceutical component suppliers, and service providers. Before launching his consultancy, Paul spent 20 years at GlaxoSmithKline (GSK), where he led teams in the development of inhaled products across various delivery systems, such as dry powder inhalers, pressurized metered dose inhalers, and nebulizers. His leadership was instrumental in taking products like Relvar/Breo Ellipta from early development stages through clinical trials, registration, launch, and lifecycle management. Paul's work has been pivotal in shaping GSK's entire inhaled product franchise. At the upcoming #VLDDCP Paul will delve into the importance of understanding customer needs, creating quality target product profiles, and driving innovation in real-world contexts. Join Paul Johnson and other industry leaders for a deep dive into the latest trends in drug-device combination products. Don’t miss this opportunity to connect with professionals, gain cutting-edge insights, and explore the future of pharmaceutical innovation: #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

Notified body opinions for single integral products: 3 years in, where do we stand? ▶️ Notified body capacity for Article 117 reviews ▶️ Experience on submissions to multiple notified bodies: classification, process, requirements ▶️ Practical advise for Article 117 submissions Join Juan Martín Carriquiry, Beyond Conception GmbH 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 #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

Excited to introduce Juan Martín Carriquiry, Partner at Beyond Conception GmbH, as a speaker at the 🔸6th Drug-Device Combination Products🔸 summit, taking place on October 15-16, 2024, in Berlin, Germany. Juan is a recognized thought leader in the field of Medical Devices and Combination Products across the EU and beyond. With extensive experience in guiding Global Pharma clients through complex compliance challenges, he has been instrumental in helping companies navigate the latest regulatory requirements. As Managing Director at Beyond Conception, Juan has been at the forefront of pioneering efforts in Europe’s Combination Products sector. He has successfully led clients to secure Notified Body Opinions and achieve compliance with key regulations, including the EU MDR, EU IVDR, and other global frameworks. His deep understanding of the EU regulatory landscape and expertise in Notified Body interactions have made him a sought-after speaker at industry-leading conferences. Juan’s approach goes beyond mere compliance; he is dedicated to creating value for his clients by aligning regulatory strategies with business goals. His insights will be invaluable to those attending #VLDDCP 2024. Join us in Berlin to gain from Juan’s wealth of knowledge and experience in the ever-evolving world of Drug-Device Combination Products. 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

▶️ Applying human factors regulatory knowledge to optimize the submission process Join Dr. Horacio M. P., Novo Nordisk A/S 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 #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

We're excited to introduce Dr. Horacio M. Pace-Bedetti, Principal Usability Researcher at Novo Nordisk A/S, as a key speaker at the #VLDDCP! With over a decade of expertise in human factors engineering, Dr. Pace-Bedetti ensures compliance with global human factors regulations for medical devices and combination products. His extensive background includes a PhD in Healthcare Technologies, leading Human Factors and Risk Management in the pharmaceutical industry. He is also actively involved in shaping industry standards, contributing to the AAMI Human Factors Group and serving as an editor for the Journal of Human Factors in Healthcare. Join us to hear his insights on optimizing regulatory submissions through human factors knowledge and register: #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/4cH86Xd #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #HFE #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #materialscience

Navigating the complex world of life sciences, especially in combination products, is a journey filled with challenges and opportunities. These products, blending drugs, devices, and biological products, are more than just scientific marvels; they are the future of medical innovation. But the real question is, how do we efficiently and safely bring these products to market while adhering to FDA regulations? It's about understanding the intricate landscape of life sciences and finding solutions that work. From addressing regulatory complexities to integrating drug and device designs, each step is crucial. Join me in exploring ways to navigate these challenges, improve efficiency, and prioritize safety. Interested in a deeper dive? Check out my blog post for more insights: https://lnkd.in/gMWwCezt #lifesciences #medicaldevices #FDAregulation

Navigating the complex world of life sciences, especially in combination products, is a journey filled with challenges and opportunities. These products, blending drugs, devices, and biological products, are more than just scientific marvels; they are the future of medical innovation.   But the real question is, how do we efficiently and safely bring these products to market while adhering to FDA regulations?   It's about understanding the intricate landscape of life sciences and finding solutions that work. From addressing regulatory complexities to integrating drug and device designs, each step is crucial.   Join me in exploring ways to navigate these challenges, improve efficiency, and prioritize safety. Interested in a deeper dive? Check out my blog post for more insights: https://lnkd.in/gMWwCezt #lifesciences #medicaldevices #FDAregulation

We educate and we collaborate with organizations to ensure that you have the tools you need in order to succeed. The FDA appreciates early contact and opportunities to collaborate. We recommend that our Client Partners take advantage of this. We can work collaboratively to help evaluate the reimbursement landscape and implications of a device, drug or exempt designation before a company or creator forges ahead. Planning for the future helps ensure that your product has the right portfolio of clinical studies to publish in support of maximal payment as soon as possible after FDA approval. If you’re looking for someone with whom to collaborate, BCVG would be honored to join you and chart a path forward together. DM us or visit our website: bruderconsulting dot com. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights