We are excited to share an upcoming webinar exploring the intersection of AI and medical product development! 🌐 Join us for an insightful session where Diane Earp, Vice President of Regulatory Compliance at the Research Triangle Institute (RTI), will guide us through the transformative impact of AI-based technologies in the knowledge-intensive healthcare industry. 🗓️ Date and Time: January 23rd, 5 pm Eastern Time, USA January 24th, 2 am Middle East January 24th, 9 am Sydney, Australia January 24th, 6 am Hong Kong 🔗 Zoom Link: https://lnkd.in/d4wzhPDU Diane Earp brings over 20 years of expertise, currently leading regulatory affairs, quality assurance, and compliance initiatives at RTI. Her experience spans FDA/EPA/OECD GLP, FDA/ICH GCP, FDA/GMP, USDA, HIPAA, EMEA, OLAW, OSHA, and more. As the institutional liaison on regulatory and quality matters, she oversees operations across four international business units with 6000+ personnel worldwide. Join us as Diane navigates the rapidly changing environment, highlighting AI applications in in vitro diagnostics (IVDs) and medical product development. Discover existing barriers, potential enablers, and gain insights into the evolving US and European regulatory landscape. Don't miss this chance to deepen your understanding of the future of AI in healthcare! Save the date and join us for an enriching discussion. 🚀👩💼 #AIHealthcare #MedicalProductDevelopment #Webinar #RegulatoryCompliance #HealthTechInnovation
Association of Graduate Regulatory Educators’ Post
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MBA Student at Kelley School of Business- Indiana University I Senior Validation Engineer | Six Sigma Green Belt, Project Management
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
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🚀 Exciting news! 📢 We are delighted to introduce you to our new concept: FDAi News! 🎥 FDAi News is an innovative initiative aimed at making FDA (Food and Drug Administration) information more accessible and understandable. Our aim is to provide you with clear and concise summaries of articles and documents on AI published by the FDA, to keep you informed of the latest developments and regulations in the field of health and technology. For our first video, we have chosen to look at the document "𝗔𝗿𝘁𝗶𝗳𝗶𝗰𝗶𝗮𝗹 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗮𝗻𝗱 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀: 𝗛𝗼𝘄 𝗖𝗕𝗘𝗥, 𝗖𝗗𝗘𝗥, 𝗖𝗗𝗥𝗛, 𝗮𝗻𝗱 𝗢𝗖𝗣 𝗮𝗿𝗲 𝗪𝗼𝗿𝗸𝗶𝗻𝗴 𝗧𝗼𝗴𝗲𝘁𝗵𝗲𝗿" (https://lnkd.in/eVA_MwXu). This document explores how different branches of the FDA are working together to integrate artificial intelligence into medical products, opening up new opportunities for innovation in the healthcare sector. Stay tuned to find out how artificial intelligence is transforming the medical products sector and much more! 🌟 #FDAiNews #Innovation #ArtificialIntelligence #Healthcare #Technology #FDA #Regulation
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Regulatory Affairs | Regulatory Strategy and Intelligence | Drug Development | Biocon | KPMG | Novo Nordisk | Founder of Bionaltek
An insightful article on the Inslico CT and it's importance in drug development. Kudos to the team of #KPMG_UK Anusha Foy Varun Sukumaran, Liam Johnstone and everyone.
Bicentennial Turing Chair in Computational Medicine @ The University of Manchester
🚀 Unlock the Future of Healthcare with KPMG's Latest Report! 🚀 In an age where technology and artificial intelligence are reshaping industries, KPMG UK Life Sciences Regulatory Solutions dives deep into the game-changing potential of Computational Modelling and Simulation (CM&S) and In Silico Evidence (ISE). 🌐💡 Why This Matters: 1️⃣ Accelerate R&D: Expedite product development and bring life-saving treatments to market faster. 2️⃣ Innovate Safely: Reduce reliance on animal testing with in silico clinical trials, ensuring treatments are effective across diverse populations. 3️⃣ Cost-Efficient: Slash R&D costs and risks, and navigate global regulatory landscapes with confidence. Discover: 👉 The benefits and challenges of adopting CM&S and ISE. 👉 Essential steps for safe and effective implementation. 👉 Strategies to bridge the skills gap and achieve a robust return on investment. 💡 Join the Transition: Embrace the collaborative effort to develop ISE, undertake regulatory science and innovation, develop standards and best practices, and help establish Centres of Excellence in in-silico Regulatory Science and Innovation. Together, we can transform healthcare and improve lives worldwide. 🌍✨ 📥 Read the full report now and be part of the future of healthcare innovation! https://lnkd.in/ePQv5Dx2 Thanks to Anusha Foy, Varun Sukumaran, and Liam Johnstone for a great report and to multiple contributors from the #InSilicoUK Pro-Innovation Regulations Network https://lnkd.in/dp5Ch24U. Innovate UK Innovate UK Business Connect Royal Academy of Engineering The Academy of Medical Sciences BioIndustry Association (BIA) The Association of the British Pharmaceutical Industry (ABPI) ABHI Regulatory Affairs Professionals Society (RAPS) TOPRA - The Organisation for Professionals in Regulatory Affairs techUK NAFEMS Medicines and Healthcare products Regulatory Agency NICE - National Institute for Health and Care Excellence Food Standards Agency Medical Device Innovation Consortium (MDIC) Avicenna Alliance VPH Institute FDA Reagan-Udall Foundation for the FDA #HealthcareInnovation #LifeSciences #AI #ResearchAndDevelopment #KPMG #InSilico #ComputationalModelling #RegulatorySolutions
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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
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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
Meet Us @ CPHI & PMEC 2024 June 19-21 Shanghai New International Expo Center, China
freyrsolutions.com
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Marketing Head || Artificial Intelligence || Ex- Merc|| Ex-Eicher|| Ex-Audi || MBA-marketing
HCP engagement on digital channels is not new... As user experience becomes a priority with AI-enabled solutions in our everyday affairs, are witnessing a drop in HCP visits for medical information. Well AI has the potential to elevate your strategies to communicate medical information as expected. Here is a white paper to delve into. #KOLengagement #hcpengagement #pharmacy #healthcare #information #technology #whitepaper #Aiforlifesciece #lifescience #medicalaffairs
Did you know that HCPs often avoid visiting pharmaceutical websites due to the challenges they face in locating essential information? With Ariya, we're breaking down those barriers to make medical insights readily available at their fingertips. Ariya simplifies the way medical information is accessed, ensuring that HCPs spend less time navigating and more time on what truly matters. Curious about how AI can elevate Medical Affairs efficiency? Read our whitepaper on 'Elevate Medical Affairs Efficiency Through AI" below. #ariya #AI #medicalaffairs #medicalinformation #hcps #pharmaceutical #healthcare
Whitepaper- Elevate Medical Affairs through AI
phamax14814.ac-page.com
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Dear LinkedIn Network, I’ve officially started a business named International Conference on Harmonization (ICH) Foundations, LLC. We (I) specialize in 4 words: Biostatistics and Regulatory Affairs. Science has always been challenging but even greater now than ever before. One of Statistical Science’s true objectives is to reduce or eliminate all together sources of bias – both from the subconscious or conscious mind, intentional or not. There are two sides to every coin, and when things get heated, we already know the rules within the FDA’s approach of ICH to get new therapies approved on the market to help those with severe and life-altering diseases. We do this by running randomized controlled clinical trials and by performing rigorous statistical analysis for safety, efficacy, and long-term risk vs. benefit for your product. We lead alongside your company’s matrix environment of biometrics, clinical, medical, regulatory teams to make things happen as smoothly as possible! If you enjoy, or simply like the name of the business, please give a like and connect.
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KPMG Life Science Regulatory Consultant | Former MHRA Senior Assessor | Drug Development Professional | 20+ Years Driving Innovation & Compliance | Social Mobility Advocate
This was a great collaborative effort - Computational Modelling and Simulation (CM&S) and In Silico Evidence (ISE) are revolutionizing drug development by accelerating R&D, reducing costs, and enhancing safety. These cutting-edge technologies enable virtual testing of treatments, ensuring efficacy and compliance before clinical trials. Such an important area of healthcare and drug development requires stakeholders to embrace the future of pharmaceuticals with CM&S and ISE. #DrugDevelopment #Innovation #CM&S #ISE #Pharmaceuticals #R&D #regulatorysolutions
Bicentennial Turing Chair in Computational Medicine @ The University of Manchester
🚀 Unlock the Future of Healthcare with KPMG's Latest Report! 🚀 In an age where technology and artificial intelligence are reshaping industries, KPMG UK Life Sciences Regulatory Solutions dives deep into the game-changing potential of Computational Modelling and Simulation (CM&S) and In Silico Evidence (ISE). 🌐💡 Why This Matters: 1️⃣ Accelerate R&D: Expedite product development and bring life-saving treatments to market faster. 2️⃣ Innovate Safely: Reduce reliance on animal testing with in silico clinical trials, ensuring treatments are effective across diverse populations. 3️⃣ Cost-Efficient: Slash R&D costs and risks, and navigate global regulatory landscapes with confidence. Discover: 👉 The benefits and challenges of adopting CM&S and ISE. 👉 Essential steps for safe and effective implementation. 👉 Strategies to bridge the skills gap and achieve a robust return on investment. 💡 Join the Transition: Embrace the collaborative effort to develop ISE, undertake regulatory science and innovation, develop standards and best practices, and help establish Centres of Excellence in in-silico Regulatory Science and Innovation. Together, we can transform healthcare and improve lives worldwide. 🌍✨ 📥 Read the full report now and be part of the future of healthcare innovation! https://lnkd.in/ePQv5Dx2 Thanks to Anusha Foy, Varun Sukumaran, and Liam Johnstone for a great report and to multiple contributors from the #InSilicoUK Pro-Innovation Regulations Network https://lnkd.in/dp5Ch24U. Innovate UK Innovate UK Business Connect Royal Academy of Engineering The Academy of Medical Sciences BioIndustry Association (BIA) The Association of the British Pharmaceutical Industry (ABPI) ABHI Regulatory Affairs Professionals Society (RAPS) TOPRA - The Organisation for Professionals in Regulatory Affairs techUK NAFEMS Medicines and Healthcare products Regulatory Agency NICE - National Institute for Health and Care Excellence Food Standards Agency Medical Device Innovation Consortium (MDIC) Avicenna Alliance VPH Institute FDA Reagan-Udall Foundation for the FDA #HealthcareInnovation #LifeSciences #AI #ResearchAndDevelopment #KPMG #InSilico #ComputationalModelling #RegulatorySolutions
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Did you know that HCPs often avoid visiting pharmaceutical websites due to the challenges they face in locating essential information? With Ariya, we're breaking down those barriers to make medical insights readily available at their fingertips. Ariya simplifies the way medical information is accessed, ensuring that HCPs spend less time navigating and more time on what truly matters. Curious about how AI can elevate Medical Affairs efficiency? Read our whitepaper on 'Elevate Medical Affairs Efficiency Through AI" below. #ariya #AI #medicalaffairs #medicalinformation #hcps #pharmaceutical #healthcare
Whitepaper- Elevate Medical Affairs through AI
phamax14814.ac-page.com
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The rapid emergence of AI tools hold significant potential for drug development and healthcare. But it also presents new challenges for regulators to address. The article below summarizes some of the opportunities offered by this technology as well as the obstacles that authorities will need to overcome.
Regulators Face Novel Challenges as Artificial Intelligence Tools Enter Medical Practice
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