A panel convened by the FDA voted overwhelmingly yesterday against key provisions of the Clozapine Risk Evaluation and Mitigation Strategy (REMS). https://ow.ly/sJPt50UbqEu #Schizophrenia
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Change up how you're doing things. See results. ?? Our new infographic reveals how RBQM is transforming CRO compliance and risk management. From proactive risk handling to meeting ICH and FDA guidelines, we have the ingredients for smarter, faster trials. Big or small CRO, our AI-driven solutions make the difference. Curious? Dive in:?? https://hubs.ly/Q02HwxHm0 #RBQM #ClinicalTrials #CROs #ClinicalResearch #RiskManagement
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Regulatory Affairs (EU MDR, EU IVDR, US FDA 510 (k), UKCA, TGA)|Outsourced PRRC|Member of RAPS Chapter Germany|Mentor (Pathway Mentorship Program)
?? Clinical Benefit & Residual Risks During the second day of #Horizon2024 conference, Edward B. delivered an insightful talk on Risk Management in the Clinical Evidence Feedback Loop, focusing on the critical balance between clinical benefits and residual risks. The points displayed on the slide effectively illustrated these concepts. #clinicaldata #clinicalbenefits #clinicalevaluation #medicaldevice #residualrisks #iso14971 #EUMDR
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We are excited to announce our final Health & Care webinar in the series for 2024; exploring current issues that may affect your business in today’s ever-evolving environment. This webinar, on 7 November, is in conversation with Naomi B. from Travelers Europe and focuses on Allergen Risk Management, covering an overview of food-related allergen risks in the UK, the current legal position, and some practical steps for managing food allergen risks. Register here >> https://travl.rs/4cNgbZO
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Enhance your REMS efficiency with our lessons learned from over 120 REMS programs. Read our white paper “Lessons Learned When Implementing a REMS” to navigate FDA criteria, risk mitigation and innovative approaches. Download here: https://hubs.li/Q02JDzTT0 #PatientsFirst #REMS #SafetyandRiskManagement #PatientSafety
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? Happening in just one hour: An ACO-focused webinar “Population Risk Management in Action: Automating Clinical Workflows to Improve Medication Adherence.” There's still time to register and tune in ?? https://bit.ly/4eqEizL
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Launching an EAP has many challenges from managing adverse events to navigating complex European market guidelines, therefore, planning and risk management are essential. Take a look at our recent article to learn how to successfully implement an EAP in Europe whilst also ensuring patient safety and program integrity. https://lnkd.in/gwJY28wX #RareDiseases #OrphanDrugs #RealWorldEvidence #PatientAccess #Biotechs
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By analyzing potential root causes, such as, breakdown in SOPs measures, reviews of chain of custody forms, packing lists, bill of lading/freight, validating certificates of authenticity, calibrating measuring equipment/tools etc., during the SCRM process, allows for sustainable measures and proper mitigation.
One way we support the future of #PublicHealth is by encouraging supply chain risk management (SCRM). By proactively implementing SCRM practices along every stage of the supply chain, #MedicalDevice manufacturers, distributors, and health care providers can help identify and mitigate supply chain threats. As we close out National Public Health Week, we invite you to learn more: https://lnkd.in/eaJKBB-a #NPHW
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Nuclear verdicts threaten physicians and promote defensive medicine. Bob White will highlight strategies and insights for physicians and healthcare leaders to combat this alarming trend. Join the Florida Medical Association webinar today to learn more.
Join us on Wednesday, October 30 for a CME webinar on high-indemnity verdicts. Robert E. White Jr., president of The Doctors Company and TDC Group, will highlight the primary drivers of high-indemnity claims, risk mitigation strategies, and how physicians can advocate for their profession in this environment. Register here: https://buff.ly/3UhEeKc
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Webinar on S1B(R1)
Join Metisox webinar on June 19th, 2024 and learn how we can help you apply S1B(R1) ICH guidelines in carcinogenic risk assessment. Register here: https://lnkd.in/ddNsAkMz
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Mark your calendars! ?? Join Neeraj Shah from Boston Insights & Mia Van Allen, MMath, PMP Van Allen from Supply Chain Wizard, LLC Chain Wizard on December 4th for an informative webinar on "Turning Clinical Supply Chain Risks into Resiliency" ?? Key takeaways: ?? Identify Risk Sources: Learn how to pinpoint vulnerabilities in your clinical supply chain. ?? Post-Pandemic Trends: Understand the evolving risk landscape in a post-COVID world. ?? Build Resilience: Develop strategies to mitigate risks and ensure trial continuity. ?? Measure Impact: Quantify the adverse effects of risks on your clinical supply chain. Register now and learn about a Risk Management approach tailored to Clinical Supply Chain: https://lnkd.in/dpXFburv #ClinicalTrials #SupplyChain #RiskManagement #Resilience #SupplyChainWizard #BostonInsights
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