A unique opportunity for regulatory education and networking in a can't-miss location. The RAPS European Clinical, Risk and Postmarket Surveillance Conference is your chance to join other regulatory professionals interested in navigating EU MDR and IVDR requirements around clinical evaluation, risk management, and post-market surveillance Join us in Barcelona and come back with actionable solutions in each of these three areas that you can implement right away. Book your ticket today: https://bit.ly/4c8aUfI
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Mark your calendars for October 23-24, 2024, and join Keith Morel in Barcelona for the Regulatory Affairs Professionals Society (RAPS) 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥, 𝐑𝐢𝐬𝐤, 𝐚𝐧𝐝 𝐏𝐨𝐬𝐭𝐦𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞! Keith Morel will lead a key session on 𝐩𝐨𝐬𝐭-𝐦𝐚𝐫𝐤𝐞𝐭 𝐬𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞, focusing on exploring actionable strategies for navigating the evolving MDR and IVDR requirements in clinical evaluation, risk management, and post-market surveillance. This is a must-attend session for regulatory professionals looking to stay ahead in the field. Don't miss this opportunity to connect with industry experts and gain insights that can enhance your regulatory practices. For more details, visit https://lnkd.in/e7PsBcMg. #RAPSEurope2024 #MedicalDevices #RegulatoryAffairs #MDR #IVDR #PostmarketSurveillance #ClinicalEvaluation #RiskManagement #MedicalDeviceCompliance
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Sponsors and marketing authorization holders must navigate complicated and intertwined regulatory requirements to move a #ClinicalTrial forward. PPD discusses the complexities of risk identification, management, and reporting. Watch the webinar: https://bit.ly/3HFAuvq
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📢 Top MDR Submission Feedback: What Could Delay or Risk Your EU MDR Technical Document Assessment 📢 This comprehensive document encapsulates valuable insights and expert knowledge gathered from numerous MDR regulatory submissions. CLIN-r+ shares these learnings to support manufacturers in their MDR submission processes, highlighting key feedback from MDR-notified body technical documentation audits. Discover stringent regulations, common nonconformities in device description, testing, risk management, and post-market surveillance, and how to effectively address deficiency reports. Our recommendations will guide you in navigating the complexities of MDR compliance, ensuring a smooth and successful submission. Don’t miss out on this essential resource for your regulatory journey: https://lnkd.in/eQUSBdz5 #MDRCompliance #MedicalDevice #RegulatoryAffairs #HealthcareInnovation #valuableinsights #eumdr #riskmanagement #keytosuccess #technicaldocumentation #medtech #medicaldeviceregulation
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Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker 🐝
Live Recap from the RAPS European Clinical, Risk, and Postmarket Surveillance Conference in Barcelona Following the Plenary Session, day one kicked off with "How to Tame Your Benefit-Risk Evaluation." This morning's session featured insights from Björn-Carsten Schüre and Grit Kasper from Metecon GmbH, along with Elke Beß from TÜV Rheinland Group, discussing the complexities of benefit-risk assessments for medical devices. MedTech manufacturers can no longer rely on vague statements like “the benefit-risk ratio is positive”—regulators now expect a detailed, substantiated evaluation. The speakers detailed how clinical evaluation, risk management, and post-market surveillance ALL play vital roles in building a strong argument under MDR and ISO 14971:2019. If you’re looking for practical guidance, including how to quantify benefit-risk ratios and apply lessons, check out “10 Tips for Risk-Benefit Argumentation Success”, summarizing the key takeaways from this session. #riskbenefit #pms #mdr #iso14971 #clinical #sota
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Technical Consultant | Project Management | Cosmetics Regulations | Contract Research Organization (CRO) | Certified Principal Investigator | Cross-functional Collaborator
Learn more about the EU Medical Device Regulations with our webinar series!
Registration is now open! Our next "EU MDR Roadmap: Guiding Your Compliance Journey" comprehensive virtual training is taking place in September. This course provides learners with a 5-day workshop on the EU MDR (Medical Device Regulation). The 5 modules covered include: - MDR Overview - MDR Risk Management: Pre and Post Market - MDR Clinical Evaluation - MDR Documentation Requirements - MDR Post Market Surveillance Requirements Interested in only one or two of the courses? These are also offered as individual training sessions. Learn more & book your training here 👉 https://bit.ly/3zj4so2 #MedicalDevices #MDR #MDD #SGSNorthAmerica
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There’s still time to join our upcoming webinar, “𝐌𝐚𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐑𝐢𝐬𝐤 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐄𝐔 𝐌𝐃𝐑: 𝐓𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧, 𝐆𝐒𝐏𝐑, 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬”. 📆 Date: 16 July 2024 🕑 Time: 14:00 - 15:00 SGT This webinar is designed to provide you with a thorough understanding of the essentials of risk management within the EU MDR framework. Learn about risk management gaps in Technical Documentation (TD) and post-production expectations in our webinar. Gain insights into SPR 3 - ISO 14971:2019 (TR 24971) and common pitfalls in TD and QMS during MDR certification. Enhance your expertise and stay ahead in the field of medical device regulation. Register now ➡️ https://brnw.ch/21wLi5N #DNV #MedicalDevices #MedicalDeviceManufacturing #MDR #MedicalDeviceRegulation
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🎧 Dive into the latest RAQA Cafe Episode 12: "Risk Management, Clinical Evidence and Post-Market Reporting" for a masterclass in medical device regulations. Dr. Beatriz Rodriguez Grande and Dr. Sean Bird from NAMSA's Medical Writing team share their expertise on creating robust documentation that meets regulatory standards. Learn how to effectively manage risk, gather clinical evidence and handle post-market surveillance. This episode is packed with actionable advice, including tailoring documentation for your audience, coordinating information seamlessly and demonstrating compliance through data-backed evidence. Whether you're in the industry or just interested in the field, this conversation is a must-listen! Listen to the full episode now >> https://lnkd.in/g-Kz_3yf #RAQACafe #MedicalDevices #RegulatoryExcellence #NAMSAGlobal
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NAMSA has amazing medical writers who have diverse backgrounds. Their pooled knowledge on clinical, regulatory and quality requirements should be put to great use by anyone needing medical writing. On this episode I got to reconnect with a former coworker (Sean Bird, Ph.D. B) and got to meet another colleague (Beatriz Rodriguez Grande, Ph.D.). #medicalwriting #riskmanagement #clinicalevaluation #regulatoryaffairs #qualityassurance #medicaldevices
🎧 Dive into the latest RAQA Cafe Episode 12: "Risk Management, Clinical Evidence and Post-Market Reporting" for a masterclass in medical device regulations. Dr. Beatriz Rodriguez Grande and Dr. Sean Bird from NAMSA's Medical Writing team share their expertise on creating robust documentation that meets regulatory standards. Learn how to effectively manage risk, gather clinical evidence and handle post-market surveillance. This episode is packed with actionable advice, including tailoring documentation for your audience, coordinating information seamlessly and demonstrating compliance through data-backed evidence. Whether you're in the industry or just interested in the field, this conversation is a must-listen! Listen to the full episode now >> https://lnkd.in/g-Kz_3yf #RAQACafe #MedicalDevices #RegulatoryExcellence #NAMSAGlobal
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🎧 Dive into the latest RAQA Cafe Episode 12: "Risk Management, Clinical Evidence and Post-Market Reporting" for a masterclass in medical device regulations. Dr. Beatriz Rodriguez Grande and Dr. Sean Bird from NAMSA's Medical Writing team share their expertise on creating robust documentation that meets regulatory standards. Learn how to effectively manage risk, gather clinical evidence and handle post-market surveillance. This episode is packed with actionable advice, including tailoring documentation for your audience, coordinating information seamlessly and demonstrating compliance through data-backed evidence. Whether you're in the industry or just interested in the field, this conversation is a must-listen! Listen to the full episode now >> https://lnkd.in/g-Kz_3yf #RAQACafe #MedicalDevices #RegulatoryExcellence #NAMSAGlobal
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SVP at TRI - The RBQM Experts | Enabling Pharma & CROs to successfully implement Risk-Based Quality Management | Risk Assessment | Central Monitoring | RBM | Subject Monitoring
Using central monitoring for a risk-based approach to improving quality & safety should be an affordable option for all clinical studies. What are the key metrics to track for quality, safety, and compliance? Join our free webinar today to find out... 👇
🚨 Last Call for Our Webinar on Key Risk Indicators (KRIs) in Clinical Trials! 🚨 📅 Date/Time: 26th September @ 10am EST / 3pm BST 🔗 Register here: https://lnkd.in/dGpH_K9G Are you involved in clinical trials? Don't miss this essential session! Our expert, Duncan, will explore the critical role of Central Monitoring and how it integrates with Risk-Based Quality Management (RBQM). Discover the most commonly used Key Risk Indicators (KRIs) and learn how they can impact the core aspects of your study—whether you’re focusing on Safety, Quality, Compliance, or a combination of all three. See you there! Sponsors and CROs Only #webinar #rbqm #kri #keyriskindicators #clinicaltrialsuccess #compliance #quality #safety
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