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The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," This framework aims to foster innovation, safeguard public health, and promote regulatory approaches that support AI's responsible use in medical product development.   🗝 Key points: 🌐 Foster Collaboration to Safeguard Public Health 💡 Advance the Development of Regulatory Approaches that Support Innovation 📚 Promote the Development of Harmonized Standards, Guidelines, Best Practices, and Tools 🔍 Support Research Related to the Evaluation and Monitoring of AI Performance   How do you see AI transforming the healthcare industry in the coming years? #ArtificialIntelligence #HealthcareInnovation #FDA #MedicalDevices #PatientCare #HealthTech #DigitalHealth #AIinHealthcare

Pfizer representatives Dr Xuemai Cai and Lukas Adamowicz discusses how they are leveraging digital health technology to solve drug development challenges and the unique data algorithm package used to validate gait. Read the article here: https://lnkd.in/e7n3WkjH #clinicalinnovation #technology #endpoints #CRAACO2024 #clinicaltrials #ClinicalResearch

Excited to share my new certification in Innovation in Medical Product Development from FDA! Attended the Regulatory Education for Industry (REdI) Annual conference on May 29th-30th, gaining valuable insights into industry changes and efforts to enhance product safety. Seminars covered clinical trial management, drug management and production, compliance, and AI in the Healthcare Industry. This learning is crucial to staying updated with trends and understanding regulatory bodies' adaptations. A key takeaway for me was Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. #FDA #MedicalProductDevelopment #Innovation #AI #HealthcareIndustry

The future of drug safety is proactive, not reactive. This article explores how AI and data are revolutionizing pharmacovigilance, helping us identify risks before they become problems to shape a safer healthcare industry. Learn more: https://lnkd.in/eDfUqSfW

There’s no time to waste in charting new horizons toward #patient success. The first step? Staying informed about the latest #lifesciences developments and discovery. Preview some featured articles in our latest issue of #DIAGlobalForum: ➡️ US #DrugPricing and Reimbursement: Players, Payers, #PBMs, and Prospects ➡️ Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework ➡️ Fair Pay for #PatientEngagement: Navigating the Evolving Landscape of Remuneration See our full February ‘24 publication and previous issues at https://ow.ly/YfFb50QEHmb #DIA2024 #DIApublications #biotech #biopharma #clinical #trialresearch

First day at #ScopeEurope is wrapping up. With sessions focusing on streamlining clinical trials, integrating technologies, and emphasis on the patient voice, it was an inspiring day. I am looking forward to chairing and moderating tomorrow's sessions on clinical trial design alignment and understanding the EU AI Act, as well as a fireside chat about the legal landscape and impact of the elections on the industry. #clinops #biopharma #pharma #ai #regulatory

Join Freyr as our esteemed Senior Director, RoW, Fengqin (Jane) Zhang and Associate Director, RoW, Mandy Zhao, attend CPHI & PMEC 2024 (June 19-21). We're excited to connect with colleagues and industry leaders! Over three (03) action-packed days, Jane and Mandy will delve into: * 𝐄𝐧𝐝-𝐭𝐨-𝐄𝐧𝐝 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: Get insights on streamlining your product registration process. * 𝐅𝐫𝐞𝐲𝐚 - 𝐔𝐧𝐯𝐞𝐢𝐥𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Discover our revolutionary AI tool, Freya, and see how it empowers you with robust AI-driven strategies. * 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐞𝐱𝐢𝐭𝐢𝐞𝐬: Gain valuable knowledge on the latest Regulatory practices to ensure seamless compliance. Don't miss this opportunity to connect with Mandy and Jane to explore how our solutions can help you conquer Regulatory challenges! https://lnkd.in/gvtG7A9k #CPHI2024 #PMEC2024 #PMECChina #RegulatoryAffairs #AI #FreyrSolutions

Join Freyr as our esteemed Senior Director, RoW, Fengqin (Jane) Zhang and Associate Director, RoW, Mandy Zhao, attend CPHI & PMEC 2024 (June 19-21). We're excited to connect with colleagues and industry leaders! Over three (03) action-packed days, Jane and Mandy will delve into: * 𝐄𝐧𝐝-𝐭𝐨-𝐄𝐧𝐝 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: Get insights on streamlining your product registration process. * 𝐅𝐫𝐞𝐲𝐚 - 𝐔𝐧𝐯𝐞𝐢𝐥𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Discover our revolutionary AI tool, Freya, and see how it empowers you with robust AI-driven strategies. * 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐞𝐱𝐢𝐭𝐢𝐞𝐬: Gain valuable knowledge on the latest Regulatory practices to ensure seamless compliance. Don't miss this opportunity to connect with Mandy and Jane to explore how our solutions can help you conquer Regulatory challenges! https://lnkd.in/gvtG7A9k #CPHI2024 #PMEC2024 #PMECChina #RegulatoryAffairs #AI #FreyrSolutions

How can #MedicalAffairs teams lead the charge in transforming data into actionable insights? From overcoming resource limitations to harnessing the power of #AI check out our blog recap of a recent Medical Affairs Professional Society (MAPS) webinar where industry experts shared best practices for managing complex data sources. ⬇️ https://hubs.la/Q02S4MNh0 #Pharma #MedicalExcellence #MAPSEvents

Life sciences companies are some of the most document-intensive companies anywhere. Drug development clinical trial reports… study participant documentation… patient forms… hospital recordkeeping… importing legacy documents into new systems… even medical supply chains… Documents and the data they contain play a central role in the #lifesciences industries. But accessing and using this data has been a tedious, costly, error-prone process. Docugami turns complex #documents into #data. From clinical trial reports to patient records to contracts, we can handle the toughest long-form documents. Find out more: https://lnkd.in/gaDqHkbc