CPhI Conferences’ Post

Did you know? New drugs must navigate a complex development process before reaching the market. Along this journey, numerous regulatory challenges must be overcome to ensure patient safety and reliability. 🚨 Register now https://ow.ly/JqIT50TmK8R and learn from our RA expert! #Pharma #RA #Bachem #Webinar #RegulatoryAffairs #Challenges

Did you know? In 2019, the FDA reported that almost all of new drug applications included patient experience data – and it is only getting more patient-driven. This shift towards patient-centric research is transforming how medicines are developed and approved. Hear more about this impact from our recent webinar with Emma Sutcliffe and Mark Doyle. https://ow.ly/Arwg50RXRuf #PatientEngagement #ClinicalTrials #DrugDevelopment

The FDA has today announced a final guidance "510(k) Third Party Review Program and Third Party Emergency Use Authorization Review" This document supersedes “510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” issued on March 12, 2020. 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 at MedBoard.   #intelligence #notifiedbody #audit #medboard #medicaldevices #medtech #eumdr #hospital #medicaldevice #fda #RegulatoryAffairs #regulatoryintelligence #clinicalinvestigations #510k

🧐 Did you know that only 1% of adverse drug reactions are reported directly by patients? And many struggle with language barriers, complex forms, or lack of real-time support. But that changes today! 🌍💡 Introducing 𝗣𝗮𝘁𝗶𝗲𝗻𝘁𝗦𝗮𝗳𝗲—a revolutionary solution that empowers patients to take charge of their safety and health effortlessly, from anywhere in the world. PatientSafe bridges the gap between patients and pharmaceutical companies, making reporting simple, accessible, and impactful. With PatientSafe, we're making healthcare more inclusive, transparent, and patient-centered. Discover how PatientSafe can make a difference! with Global Value Web #PatientSafe #PatientSafety #HealthcareInnovation #PatientEmpowerment #GlobalValueWeb #NewLaunch

Curious about how GenAI is impacting on pharma regulatory affairs? Discover insights from leading health authorities: 🔹 FDA: AI as a medical device, personalized medicine, and enhancing supply chains.  🔹 EMA: Encourages AI in drug development and regulatory processes.  🔹 Health Canada: Supports responsible AI development and diagnostic tools. 📢 Book a free session: https://bit.ly/323Wsa1 #pharma #regulatoryaffairs #genai #fda #ema #healthcanada #innovation #healthcaretechnology #gramener

We are excited to announce Celegence's participation as an Innovator Sponsor at 𝐑𝐀𝐏𝐒 𝐄𝐮𝐫𝐨 𝐂𝐨𝐧𝐯𝐞𝐫𝐠𝐞𝐧𝐜𝐞 2024, taking place in Berlin from May 6th to 8th. As pioneers in tech-enabled solutions for regulatory affairs, we invite you to join us at 𝐁𝐨𝐨𝐭𝐡 𝐁12 to explore our latest advancements and gain invaluable insights into navigating the evolving #regulatory landscape. 🤖 Discover how our innovative AI-infused solutions redefine reliability, accelerate processes, and optimize costs in managing #regulatoryaffairs. If you are attending the conference, you'll also have the opportunity to join our sponsored presentation, where our experts Shruti Sharma and Anushree Singh, PhD will unveil strategies to enhance #compliance and streamline regulatory processes using cutting-edge technology: “𝐋𝐞𝐯𝐞𝐫𝐚𝐠𝐢𝐧𝐠 𝐀𝐈 𝐟𝐨𝐫 𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐏𝐌𝐂𝐅 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬” 📅  Tuesday, May 7, 2024 | 🕓 16:10 – 16:40 CEST | 📍  Room A 05 + A 06 To register for RAPS Euro Convergence 2024 and reserve your spot at our sponsored presentation: https://lnkd.in/egZjV6cZ Explore further details about our attendance and presentation here: https://lnkd.in/gvwW5yBA We look forward to connecting with you at RAPS Euro Convergence 2024 and sharing insights to help you stay ahead in today's competitive regulatory market. #medicaldevices #pharmaceuticals #combinationproducts #IVD #pmcf #Berlin2024 #RAPS24 #mdr #eumdr #pmcfsurveys #RAPSConvergence #RegulatoryCompliance #MedTech #Clinical #Medicalwriting #Healthtech

Unlock the Secrets of Regulating Drug Device Combination Products:  Are You Ready to Navigate the Complex Regulatory Landscape? Dive into our latest blog where we dissect the intricacies of bringing these innovative products to market, offering valuable insights and expert guidance. Visit our service page for comprehensive support tailored to your needs. Let's shape the future of healthcare together. https://lnkd.in/dsbcU9_a Get connected:  Mail ID: enquiry@operonstrategist.com  Phone no: +91 9370283428  .  .  .  #MedTechRegulation #HealthcareCompliance #CombinationProducts #RegulatoryInsights #MedicalDeviceInnovation #PharmaRegulations #FDACompliance #HealthcareCompliance #MedicalDeviceConsultants #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting 

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

Thoughts on this? >> EMA looks to make its drug approval processes more efficient >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #pharma #biotech #productmarketing

Unlock the Secrets of Regulating Drug Device Combination Products:  Are You Ready to Navigate the Complex Regulatory Landscape? Dive into our latest blog where we dissect the intricacies of bringing these innovative products to market, offering valuable insights and expert guidance. Visit our service page for comprehensive support tailored to your needs. Let's shape the future of healthcare together. https://lnkd.in/eU78Bjr2 Get connected:  Mail ID: enquiry@operonstrategist.com  Phone no: +91 9370283428  .  .  .  #MedTechRegulation #HealthcareCompliance #CombinationProducts #RegulatoryInsights #MedicalDeviceInnovation #PharmaRegulations #FDACompliance #HealthcareCompliance #MedicalDeviceConsultants #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting