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Pharmacovigilance World 2024 will serve as a knowledge-sharing and networking platform, providing a unique opportunity for researchers, pharmacists, healthcare professionals, industry representatives, and regulatory authorities to come together and discuss the latest trends, challenges, and advancements in pharmacovigilance. By sharing experiences and best practices, the organisers aim to enhance global drug safety and improve patient outcomes. The conference will delve into various topics such as signal detection and management, adverse event reporting and analysis, risk assessment, benefit-risk evaluation, regulatory updates, collaboration and the integration of artificial intelligence and digital technologies in pharmacovigilance. Find out more about the event here: https://bit.ly/3S1Zrqd #PVWORLD #Pharmacovigilance

In pharmacovigilance, safety signal detection has seen minimal progress since its inception in the 1960s following the thalidomide tragedy. Despite advancements in electronic reporting, up to 95% of adverse events still go unreported, highlighting the need for smarter, proactive approaches. With the integration of advanced analytics and real-world data (RWD), safety professionals can now extract precise insights swiftly, enhancing drug safety and driving efficiency for developers. Proactive signal detection, empowered by AI-driven analysis and RWD, promises to revolutionize pharmacovigilance, reducing false positives and detecting signals earlier. By bringing signal detection closer to patients, gaps in reporting can be addressed, benefiting regulators, clinicians, and drug development companies alike. As the industry embraces these transformative technologies, patient safety will steadily improve, allowing teams to focus more on drug discovery and repurposing efforts, ultimately leading to faster access to safer medicines. #Pharmacovigilance #DrugSafety #RealWorldData #HealthcareAnalytics #PatientSafety #AIinHealthcare #MedicalResearch #DrugDevelopment #HealthTech #Innovation #PatientCare #PharmaInnovation #PersonalizedMedicine #AdverseEvents #DrugRepurposing #HealthcareEfficiency #MedicalInnovation #AIinPharma #PatientSafetyAdvocacy #DrugDevelopmentEfficiency Link to Source: https://lnkd.in/d38U4ncc

💡 MedDRA: The Backbone of Pharmacovigilance 📄 In the ever-evolving landscape of pharmacovigilance, MedDRA (Medical Dictionary for Regulatory Activities) plays a crucial role in ensuring drug safety and efficacy. It’s a standardized medical terminology that facilitates clear communication across regulatory bodies, industry, and academia. 🔍 Why is MedDRA Important? Consistency: It provides a uniform language for reporting adverse events, reducing ambiguity. Global Reach: Widely accepted by regulatory authorities worldwide, ensuring seamless global data exchange. Detail-Oriented: Its hierarchical structure allows for specific and comprehensive data capture, aiding in precise analysis and reporting. 🔧 Applications of MedDRA: 🔸Adverse event reporting and monitoring 🔸Regulatory submissions 🔸Risk management and signal detection 🔸Clinical trials and post-market surveillance 🔸By leveraging MedDRA, we enhance our ability to monitor drug safety, ultimately protecting patients and advancing public health. #MedDRA #Pharmacovigilance #DrugSafety #ClinicalResearch #Healthcare #RegulatoryAffairs #MedicalWriting #PatientSafety #LifeScience

Innovating Pharmacovigilance: 2024 MHRA GPvP Symposium Highlights Published By - MHRA Inspectorate; Date - 4 April 2024. Background: A synthesis of regulation, collaboration, and innovation enhancing compliance and patient care at the 2024 MHRA GPvP Symposium. Takeaways: 🔺 The regulatoryConnect project, a data and inspection management turning point, is set to lead the industry with its promise of enhanced efficiency. 🔺 The Remote Compliance Assessments pilot is an innovative approach that can greatly reduce re-inspection burdens, potentially changing the industry. 🔺 In the discussion, the current and future regulatory challenges of AI's role in pharmacovigilance were highlighted. 🔺 Recent inspection insights reveal critical areas for compliance improvement, emphasizing risk-based approaches. My views: The 2024 MHRA GPvP Symposium was successful, with interesting discussions on AI and regulatory innovations. The future promises more efficient pharmacovigilance and robust regulatory frameworks from data-centric projects like RegulatoryConnect and insightful compliance strategies. If you missed it: https://lnkd.in/gdeQ2kVb #RegulatoryInnovation #AIinPharma #MHRAEvents #pharmacovigilance #pharma #patientsafety 

"Using MedAssessment allowed us, as a pre-market small drug sponsor, to delay increasing headcount for pharmacovigilance activities. Because of their quality impact, MedAssessment required a very light oversight footprint, unlike other providers that required significant oversight and management to ensure quality deliverables.” – VP Clinical Operations. Don't let the burden of pharmacovigilance slow down your progress. With MedAssessment by your side, you can focus on advancing your drug development journey while ensuring patient safety. Medassessment.com #Pharmacovigilance #DrugDevelopment #MedAssessment #PatientSafety #Efficiency #MedAssessment #PharmacovigilanceExperts #Healthcare #ClinicalTrials #DrugSafety #DrugSafetySpecialist

⏳ It's almost here! World Drug Safety Congress Americas 2023 starts tomorrow! We're thrilled to be here in Boston and look forward to connecting with the brightest minds in drug safety, and have the opportunity to share insights and collectively advance the field of drug safety. Be sure to join our CEO Dr. Graeme Ladds, at 11:30am on Day 1, as we present a compelling talk on 'Safety Case Processing – Getting it Right First Time' and deep dive into the nuances of safety case processing; the critical importance of data accuracy; the impact this can have on activities such as medical review, and the growing demand for AI & automation. For those attending, we invite you to visit our booth #210, where our team is eager to provide in-depth information on all things PharSafer, as well as our cutting-edge data intake and case processing solution: RAPTAR Reporting, and explore how our services can streamline your pharmacovigilance processes and elevate your commitment to patient safety. Let's shape the future of drug safety together 🤝 Register here:  https://lnkd.in/esS2TzpQ #WorldDrugSafetyCongress #PharSafer #RAPTAR #DrugSafety #Pharmacovigilance #PatientSafety

SafePhV: Your gateway to proactive drug safety monitoring by using Artificial Intelligence and Machine learning, our database revolutionizes pharmacovigilance, empowering you to safeguard patient health confidently. #Pharmacovigilance #DrugSafety #PatientSafety #HealthcareTech #AIinHealthcare #HealthTech #HealthcareInnovation #DrugMonitoring #AdverseEvents #RegulatoryCompliance #MedicalSafety #PatientCare #Topia #SafePhV #DrugEfficacy #RiskAssessment #RealTimeInsights #HealthDataAnalysis #HealthcareQuality #PatientOutcomes #DrugRegulation #GlobalHealthcare #PublicHealth #PrecisionMedicine #HealthcareProfessional #InnovativeSolutions  

🔬 Overcoming challenges in Post-Authorization Safety Studies (PASS). There are several challenges commonly faced when conducting a Post-Authorization Safety Study. Luckily, you can combat these with proactive orchestration, subject-matter expertise, and quality data sources: 📊 Data Feasibility: Ensuring the accuracy and suitability of drug exposure and outcome data, along with the challenge of accessing comprehensive data sources, remains a significant hurdle in many countries. 👩🔬 Methodological Complexities: Factors such as the background incidence of health outcomes, drug uptake, and the identification of at-risk populations demand sophisticated study designs and methodologies. 🤝 Collaborative Efforts: The need for effective collaboration between drug manufacturers, regulatory bodies, and public health agencies to facilitate data access and optimize study design for robust evidence generation. Real-world data from Finnish and other Nordic data sources offers a unique opportunity for reliable PASS projects. Contact us at RemedyBytes to hear more how we combine our expertise with Pharmacovigilance specialist Tepsivo for first class registry studies. #rwd #pharmacovigilance #pharma #safety

Proudly share that I attended CPA's live webinar on "Future of Pharmacovigilance in India: Emerging Trends and Technologies"! This webinar provided valuable insights into the latest trends and technologies that are shaping the future of pharmacovigilance in India. I am grateful to CPA for hosting this informative session. #CPA #pharmacovigilance #india #healthcare #webinar #cpa #learninganddevelopment

𝗦𝗶𝘅 𝗜𝗻𝗱𝗶𝘃𝗶𝗱𝘂𝗮𝗹 𝗖𝗮𝘀𝗲 𝗦𝗮𝗳𝗲𝘁𝘆 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 📄𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗲𝗱 𝗶𝗻 𝗮 𝗦𝗶𝗻𝗴𝘂𝗹𝗮𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 👍 Everyone remembers the criteria for evaluating Individual Case Safety Reports (#ICSR) in pharmacovigilance, which include the presence of one patient, a reporter, a drug, and the occurrence of the adverse reaction. Naturally, these criteria extend to cases documented in medical literature📚. However, it's customary for articles to focus on a single case involving one patient. When scouring 🧑🏻💻 the medical literature for #pharmacovigilance, it's uncommon to stumble upon articles detailing multiple reliable cases of adverse drug reactions. 🔥 Nevertheless, the DrugCard platform recently stumbled upon a medical literature article detailing six cases involving different patients❗️ Such an occurrence is exceedingly rare. #drugsafety #GVP