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

From exploring advancements towards high performing, compliant, sustainable and connected combined drug-device products to insights on innovations in drug delivery, in combination products, connected devices, and regulatory compliance, these presentations by the thought leaders are are not to be missed! We’re thrilled to introduce the incredible lineup of experts joining us at #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 #drugdevelopment #DDSs #innovation #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience #drugdevicecombination #humanfactor #humanfactorengineering

The Simcyp Consortium Celebrates 25 Years: Join Our Open Day! 📅 Date: Tuesday, September 24, 2024 📍 Location: Radisson RED Hotel, London Heathrow, UK Every year, the Simcyp Consortium—comprising over 30 leading biopharmaceutical companies—convenes to discuss Physiologically Based Pharmacokinetic (PBPK) initiatives in drug development and their regulator impacts. Our members collaborate closely with Simcyp scientists, shaping the scientific evolution of the Simcyp Simulator—a powerful platform utilized by prominent regulators such as the US FDA, EMA, Health Canada, and PMDA. For the first time in history of the Simcyp Consortium, non-members are invited to join our "Open Day". This is a unique opportunity to connect with industry leaders, regulatory experts, and academics as we reflect on and celebrate Simcyp’s remarkable 25-year journey prior to the start of the Consortium meeting. Event Highlights: History of the Consortium: Formation of the consortium and its progress. Simcyp PBPK Modeling Impact: Discover Simcyp's influence on drug development and regulatory sciences focusing on drug-drug interactions, biopharmaceutics, and special populations. 👉 If you’re not already a consortium member, you may register here: https://ow.ly/OBSM50SEyuG. Create a new account by clicking on the blue ‘Sign up now’ text. After registering, you’ll receive a confirmation email. Then, click ‘Register now’ to confirm your participation. #Simcyp #PBPK #DrugDevelopment #SimcypConsortium #SimcypSimulator

REGISTER NOW 📆 C-Path's Predictive Safety Testing Consortium is delighted to announce its second public workshop on evidentiary considerations for regulatory assessment and qualification of complex in vitro models - CIVMs. Health authorities, academia professionals, model developers, and representatives from the pharmaceutical industry are encouraged to participate in this workshop. It offers a valuable platform for attendees to engage in discussions and deliberations regarding the evidentiary considerations essential for regulatory assessment and qualification of CIVMs. Through collaborative efforts, attendees will strive to reach a consensus on the standards and features necessary to enhance the performance of CIVMs as a reliable tool for drug development and regulatory assessment. The meeting agenda features sessions led by key opinion leaders, who will address general considerations for qualification. Additionally, interactive breakout sessions will concentrate on various organ systems and disease models. During these breakouts, participants will actively engage in discussions and deliberations to explore the evidentiary considerations crucial for regulatory assessment and qualification of complex in vitro models. Join us September 26 - 27, 2024 in Bethesda, Maryland. Register now: https://lnkd.in/gKXn8R4e. #CPath #PSTC #CIVM #workshop #drugdevelopment #datasharing #regulatoryscience #collaboration #globalhealth

✴ Unlock the Insights from Pharma Integrity Conference 2024 - Get Your Video Access Now! ✴ It’s hard to believe it's been over a month since the Pharma Integrity Conference 2024. Did you miss this year’s conference? We’ve got you covered! We are excited to announce that the full video of the conference, themed Digital Frontiers: Exploring Pharmaceutical Companies’ Strategies in Digital Media is now available for purchase. The video includes:   ✅ Inspirational Keynotes: Gain access to the powerful keynotes delivered by industry leaders and learn from their experiences and insights on Digital Strategies.  ✅ An Interactive Session with the HPRA led by Dr Emer O’Shaughnessy, MSD, with Q&A 📽 Our video includes all sessions, ensuring you don’t miss out on any part of the event. Whether you want to watch a specific session or the entire conference, you’ll have it all at your fingertips. Don’t miss this opportunity to gain valuable knowledge and insights from the Pharma Integrity Conference 2024. Email info@pharmaintegrity.com for more information Thank you to everyone who made the Pharma Integrity Conference of 2024 a huge success. 💫 We’re excited to share these incredible moments with you! #PharmaIntegrityConference2024 #PharmaIntegrity #VideoAccess #ProfessionalDevelopment #IndustryInsights #Innovation #Networking

🌐 Exciting News! Thermo Fisher Scientific is hosting a webinar... We are thrilled to invite you to our highly anticipated webinar, where we will delve into the topic of "The CRDMO Advantage: From Supply Chain Efficiency to Patient-Centric Value Chain." 📅 Date: Wednesday 29th May ⏰ Time: 4pm UK time 📍 Location: Online The supply chain for CDMOs is increasingly becoming a value chain, where every step from initial drug discovery and development through to manufacturing and distribution is an opportunity to make the final product more valuable to patients. Increased collaborations between CDMOs and CROs reflect and support this shift, according to a 2023 trend report titled "The Nexus Between Patient and Big Pharma" developed by Thermo Fisher Scientific in partnership with CPHI. This webinar will explore the key findings from the report, focusing specifically on the CDMO and CRO synergies that can be leveraged to streamline drug development and accelerate the delivery of safe, effective, high-quality treatments to patients. During this interactive session, industry experts will explore key topics such as: ✅ How intentional CDMO/CRO partnerships are the key to forging a future that's inherently patient-centric ✅ Strategies for leveraging a combined CRDMO (Contract Research and Development Manufacturing Organization) to simplify pathways from discovery through to market ✅ The critical role of the supply chain in clinical studies and the role of the clinical site in the value chain ✅ Effective methods for empowering clinical sites to prioritize patient needs, minimizing the impact of supply chain disruptions on clinical operations and patient care Don't miss out on this opportunity to broaden your knowledge and network with like-minded professionals. 🖱 Register now by clicking on the link below: #CRDMO #CDMO #CRO #ClinicalTrials #SupplyChainEfficiency #PatientCentric #ClinicalSupply #DrugDevelopment

We are thrilled to announce our exclusive partnership with FSHD Society and TRiNDS on the creation of the Global FSHD Innovation Hub! The Hub is a newly formed commercial entity providing FSHD specific services and products, focusing on: 🌎 Fostering global collaboration in FSHD research and pharmaceutical development 🔬 Site optimization for clinical trials 🌐 Providing crucial international data for new therapeutic and HTA approvals 💡 Improving and developing new patient registries 🧬 Validating new and innovative digital tools to further FSHD research Rare disease research requires international collaboration to develop new and improved tools and therapies. Putting patient data at the centre of this research is crucial to improving health outcomes for all. The Global FSHD Innovation Hub is one significant step in helping achieve these goals. Blaine Penny and Lawrence Korngut wrote an article for the FSHD Society's magazine The FSHD Advocate on the importance of the Hub: https://zurl.co/YgSf1 #FSHDResearch #GlobalFSHDInnovationHUB #clinicaltrials

🌍💊 Fluart Shines at the 35th CPHI in Milan! 💊🌍 Fluart was proud to participate in the 35th CPHI, held this year in the vibrant city of Milan. This global event highlighted the critical role of CDMO services in driving pharmaceutical innovation. The groundbreaking advancements showcased at CPHI reinforced a key takeaway: the pharma industry’s rapid innovation wouldn’t be possible without the support and expertise provided by CDMOs like Fluart. 🚀 From cutting-edge drug development to seamless manufacturing solutions, CDMOs are essential in ensuring that life-changing medicines reach the market efficiently and safely. We’re excited to continue leading the charge in this evolving landscape, bringing top-tier solutions to our partners around the world. https://lnkd.in/e6BeVrHw Let’s shape the future of healthcare together! 🏥💡 #Fluart #CPHI2024 #PharmaInnovation #CDMOServices #DrugDevelopment #PharmaceuticalExcellence #HealthcareInnovation #Biotech #PharmaManufacturing #LifeSciences #GlobalPharma

I am thrilled to announce the DIA Meeting 2024, which took place from June 16-19! This event gathered the world's leading minds in healthcare, pharmaceuticals, and regulatory affairs to shape the future of our industry. Expect an enlightening and transformative experience packed with insights, innovations, and strategic discussions. Key Insights and Agenda Highlights: Innovative Therapies and Technologies: Discover advancements in biopharmaceuticals, medical devices, and digital health. Regulatory Science and Policy: Engage with global regulators on new guidelines and compliance strategies. Clinical Trials and Real-World Evidence: Explore innovative trial designs and the role of real-world evidence in drug development. Patient-Centric Approaches: Learn strategies for integrating patient perspectives into healthcare delivery. Being part of DIA Meeting 2024 was an immense pleasure. The enriching discussions and valuable insights from experts have inspired me to apply these learnings and collaborate with this vibrant community to advance healthcare. Special thanks to David Fryrear, Leslie Sam and Tywnia B. for their exceptional contributions. Also, kudos to my fellow participants RAJASHEKHAR ITTEDI for the poster presentation and Vandana Mandavilli, Rama D, and Keerthi Pendri for the case competition—you’ve provided valuable insights and inspiration. #DIA2024 #HealthcareInnovation #Pharmaceuticals #RegulatoryAffairs #PatientCentric #ClinicalTrials

📈 Ready to take your next #pharma congress to the next level? We have a phenomenal congress capability in Emota, part of Inizio Engage. We've conducted some research into how to maximise your #ROI and our latest research report is now live. This report identifies: 1️⃣ Challenges faced by congress planners in pharma 2️⃣ What is required to mitigate these challenges 3️⃣ How to improve the execution of future congress events 👉 Download your copy today: https://lnkd.in/e4ePx2k3 #ConnectedCapabilities #ReimagineHealth #EventPlanning #Congress #Inizio

🌍 Honoured to Present at FIP Congress 2024! I’m thrilled to share that PharmBot AI was recognised at the FIP Congress 2024, where I had the privilege of presenting our poster titled: "Advancements in Pharmacy Practice: Introducing HealthAI Assist by PharmBot AI." This acknowledgment underscores our commitment to transforming pharmacy operations through innovative AI solutions. With a focus on improving efficiency, reducing prescription errors, and enhancing patient outcomes, PharmBot AI is paving the way for the future of pharmacy practice. A big thank you to the International Pharmaceutical Federation (FIP) for this incredible platform to showcase our vision on a global stage. As we continue to align with international goals like Saudi Vision 2030 and drive innovation in healthcare, we are excited about the potential for collaboration and partnerships to bring PharmBot AI’s solutions to new markets. If you're interested in learning more about how PharmBot AI is shaping the future of pharmacy and healthcare, feel free to connect or reach out! #PharmacyInnovation #AIinHealthcare #PharmBotAI #FIPCongress2024 #GlobalHealth