Vladlena Zozina’s Post

𝐆𝐥𝐨𝐛𝐚𝐥 #𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 #𝐌𝐚𝐫𝐤𝐞𝐭: 𝐆𝐫𝐨𝐰𝐭𝐡 𝐢𝐧 𝐃𝐫𝐮𝐠 𝐒𝐚𝐟𝐞𝐭𝐲  The pharmacovigilance market was valued at USD 6.87 billion in 2023 and is projected to grow at a CAGR of 13% from 2024 to 2030, reaching USD 16.16 billion by 2030. Pharmacovigilance plays a crucial role in monitoring the safety of medicines and vaccines by detecting and preventing adverse effects. Countries like Canada have implemented mandatory pharmacovigilance systems to ensure continuous drug safety monitoring, reinforcing the importance of this sector globally.  𝐊𝐧𝐨𝐰 𝐌𝐨𝐫𝐞:https://lnkd.in/d2G9z2N8  𝐃𝐫𝐢𝐯𝐢𝐧𝐠 𝐌𝐚𝐫𝐤𝐞𝐭 𝐆𝐫𝐨𝐰𝐭𝐡: 𝐀𝐈 & 𝐀𝐮𝐭𝐨𝐦𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐃𝐫𝐮𝐠 𝐒𝐚𝐟𝐞𝐭𝐲 The COVID-19 pandemic underscored the necessity of advanced pharmacovigilance systems. The integration of Artificial Intelligence (AI) and automation is transforming the landscape by streamlining data analysis, identifying adverse drug reactions, and predicting potential risks. AI not only boosts efficiency but also creates new roles for drug safety professionals, driving innovation and job creation in the sector. 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐓𝐫𝐢𝐚𝐥𝐬: 𝐀 𝐂𝐫𝐮𝐜𝐢𝐚𝐥 𝐒𝐞𝐠𝐦𝐞𝐧𝐭 Phase 3 clinical trials dominated the market in 2023, as they provide comprehensive data on adverse drug reactions and long-term effects. Regulatory agencies rely on data from these trials to make informed decisions regarding drug approval. With the help of AI, big data analytics, and electronic health records (EHRs), Phase 3 trials are becoming more efficient, enhancing the accuracy of drug safety monitoring.  𝐑𝐞𝐠𝐢𝐨𝐧𝐚𝐥 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬: 𝐍𝐨𝐫𝐭𝐡 𝐀𝐦𝐞𝐫𝐢𝐜𝐚 𝐋𝐞𝐚𝐝𝐬 𝐭𝐡𝐞 𝐖𝐚𝐲 North America held the largest market share in 2023, driven by its robust healthcare infrastructure, stringent regulatory standards, and significant investment in pharmaceutical R&D. The FDA in the U.S. and Health Canada ensure rigorous pharmacovigilance practices, while cutting-edge technologies like AI and machine learning further bolster the region's capabilities in monitoring drug safety. #Pharmacovigilance #DrugSafety #AIinHealthcare #ClinicalTrials #PharmaceuticalIndustry #HealthcareInnovation #BigData #Automation #PatientSafety #GlobalMarket #RegulatoryCompliance #HealthcareAI #LifeSciences

The application of AI in patient monitoring and post-marketing surveillance is at the top of Clientelis solutions pipeline

🔬💡 Cutting Pharmacovigilance Costs with AI Pharmacovigilance, the practice of monitoring drug safety, is compulsory but costly. The average cost per case is $90 (Deloitte). With cases rising tenfold over the past 20 years and continuing to grow at 15% annually (FDA), there's a clear need for efficiency. The burden of regulation by authorities like the FDA, WHO, and EMA is also increasing. These organizations are implementing stricter guidelines and requirements for monitoring and reporting adverse drug reactions. This heightened regulatory scrutiny, while crucial for patient safety, adds to the workload and costs for pharmaceutical companies. AI as a Solution: AI is transforming pharmacovigilance by automating data collection and analysis, improving signal detection, streamlining reporting, and enhancing predictive capabilities. These advancements can reduce the need for extensive human resources and minimize errors, leading to significant cost savings. AI also facilitates outsourcing tasks to qualified professionals in low-cost regions, further reducing expenses while maintaining high standards. Estimated Cost and Time Savings: Cost Savings: Automating tasks can cut the average cost per case by up to 50%.  Time Savings: AI can reduce the time required for data processing and reporting by up to 70%, completing tasks in days instead of weeks. Outsourcing Benefits: Outsourcing AI-driven tasks to low-cost regions can further cut operational costs by 20-30%. Integrating AI into pharmacovigilance processes offers substantial cost reductions and improved drug safety. Clientelis is at the forefront of AI-powered pharmaceutical services. 🚀 #AI #Pharmacovigilance #HealthcareInnovation #PatientSafety #CostEfficiency #Clientelis #Surveillance #Postmarketing #AdverseEvent #PharmaceuticalServices #BPO #PV #Materiovigilance #PharmaceuticalServices #Compliance

✨️Pharmacovigilance, the practice of monitoring the effects of medical drugs to identify and evaluate adverse reactions, is undergoing significant transformations driven by technological advances, regulatory changes, and a greater emphasis on patient safety. ⚪️"Latest Trends in Pharmacovigilance" : 🟣 Integration of Real-World Evidence (RWE) : RWE, derived from sources like electronic health records and patient registries, is increasingly being integrated into pharmacovigilance practices. This helps provide a more comprehensive understanding of drug safety and effectiveness in the general population, beyond the controlled environment of clinical trials. Regulatory bodies are now relying on RWE to support post-marketing surveillance and expedite drug approvals. 🟣 Digital Transformation : Digital technologies such as artificial intelligence (AI), machine learning, and cloud-based systems are revolutionizing pharmacovigilance. AI-powered tools are enhancing the efficiency and accuracy of adverse event detection by analyzing vast datasets, including social media and medical literature. This digital shift is streamlining data capture and improving the overall responsiveness of pharmacovigilance activities. 🟣 Patient-Centric Approaches : There is a growing focus on patient involvement in pharmacovigilance. Patients are being engaged through various channels to report adverse effects and share their experiences, which enriches the data pool and provides valuable insights into drug safety from a user perspective. This trend underscores a move towards more personalized and responsive pharmacovigilance practices. 🟣 Proactive Risk Minimization : Strategies such as Risk Evaluation and Mitigation Strategies (REMS) are becoming integral to pharmacovigilance. These proactive approaches aim to identify and mitigate potential drug-related risks early, thereby enhancing overall patient safety and reducing adverse effects. 🟣 Regulatory Harmonization : With the expansion of pharmaceutical companies globally, there is a pressing need for harmonized regulations to simplify pharmacovigilance processes across different regions. Streamlined regulatory frameworks are essential for maintaining consistent safety standards and facilitating quicker access to vital medications. ⚪️ Pharmacovigilance is a dynamic field that is evolving rapidly with technological advancements and increased regulatory focus on drug safety. As the sector continues to grow, it offers numerous opportunities for those interested in ensuring the safe use of medications. 💥Very thankful to ClinoSol Research Pvt. Ltd and Sri Sivani College of Pharmacy, N.H-5, Chilakapalem Jn., Etcherla (Mandal) Srikakulam-532485 (CC-DA) for provided this valuable session on "Exploring pharmacovigilance: Unravelling latest trends and Career Pathways" #Pharmacovigilance #LatestTrends #Learning #Exploring #Certification

🔬 Transforming #pharmacovigilance and ensuring drug/device safety with #AI and #ML. AI/ML algorithms are significantly transforming the way safety data is analyzed, adverse events are detected, and risks are mitigated. Read on to explore some of the key AI/ML use cases in pharmacovigilance and drug/device safety: https://hubs.li/Q02nqCZ00 Sign up for our webinar: "From Legacy to Leading Edge: Embracing Next-Gen CTMS" on Thursday, March 28 2024, at 11 AM EST: https://hubs.li/Q02nqBHF0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #DrugSafety #ArtificialIntelligence #MachineLearning #PatientSafety

Signal Detection in Pharmacovigilance Definition of a Signal: A signal in pharmacovigilance refers to information that arises from one or multiple sources, suggesting a new and potentially causal association between an adverse event and a drug. Unfortunately, this information is not yet established and requires further investigation. Sources of Data: Spontaneous Reporting Systems (SRS): Data collected from healthcare professionals and patients who report ADRs voluntarily. ·      Electronic Health Records (EHRs): Real-world data from patient records. ·      Clinical Trials: Data from controlled environments during the drug development phase. ·      Literature Reports: Published case studies, reviews, and clinical findings. ·      Social Media and Online Forums: Patient-reported experiences and discussions. 3. Methods of Signal Detection: Quantitative Methods: ·      Proportional Reporting Ratios (PRR): Measures the proportion of a specific ADR for a drug compared to other drugs. ·      Reporting Odds Ratios (ROR): Compares the odds of reporting a specific ADR for a drug against the odds for other drugs. ·      Bayesian Data Mining Techniques: Includes methods like Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS). Qualitative Methods: Expert Review: Assessment of case reports by experienced pharmacovigilance professionals. Signal Detection Algorithms: Automated tools and algorithms that identify patterns indicative of potential signals. Dear colleagues, If You would like to get more actual pharmacovigilance/drug safety knowledge, please subscribe to my Youtube channel Drug safety from Galyna Cordero: https://lnkd.in/dFbjtrf3

Pharmacovigilance is crucial in ensuring the safety of medications. It involves monitoring, assessing, and preventing adverse effects or any other drug-related problems. Here are some important aspects: Reporting Adverse Events: Healthcare professionals, patients, and pharmaceutical companies should report any suspected adverse reactions to regulatory authorities. Timely reporting helps in early detection and intervention. Artificial Intelligence (AI) Integration: Pharmacovigilance is increasingly leveraging AI and machine learning algorithms to enhance signal detection, automate case processing, and improve data analysis. These technologies enable faster and more accurate identification of potential safety concerns from large volumes of data, leading to more proactive risk management. Real-World Evidence (RWE): Utilizing real-world data from sources like electronic health records, wearable devices, and social media platforms is becoming integral to pharmacovigilance. RWE provides insights into medication use patterns, treatment outcomes, and adverse events in diverse patient populations and settings, complementing traditional clinical trial data. Regulatory Compliance: Pharmaceutical companies must comply with pharmacovigilance regulations set by regulatory agencies such as the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). Non-compliance can lead to regulatory actions. pharmacovigilance plays a critical role in safeguarding public health by ensuring that the benefits of medications outweigh their risks and by promoting the safe and effective use of drugs.

🌍 Navigating the Future of Pharmacovigilance 🌡️ GET Detail PDF – https://lnkd.in/gvgvGfaU In an era where patient safety is paramount, #pharmacovigilance plays a critical role in ensuring that medications are both effective and safe. As we witness a surge in #drug approvals and #clinical trials, the demand for robust pharmacovigilance practices is more crucial than ever. 🚀 Key Trends to Watch: • Technological Integration: The rise of AI and machine learning is revolutionizing how we detect and analyze adverse drug reactions, making processes more efficient and accurate. • Outsourcing: Many companies are partnering with specialized firms to streamline their pharmacovigilance operations, allowing them to focus on innovation and #patient care. • Global Regulatory Compliance: As the landscape of #drug safety regulations continues to evolve, staying compliant across regions is becoming increasingly complex and essential. 🔍 Challenges Ahead: From managing vast amounts of data to adapting to shifting regulatory frameworks, the pharmacovigilance sector faces its share of hurdles. However, these challenges also present opportunities for growth and innovation. As we look forward, it’s clear that pharmacovigilance will remain a cornerstone of the pharmaceutical industry, ensuring that safety and efficacy go hand in hand. 💡 Let’s embrace these changes and work together to enhance patient safety globally! #Pharmacovigilance #PatientSafety #HealthcareInnovation #PharmaIndustry #AI #DataManagement #Preclinical #Hospitals #Industrial

Explore how #AI is revolutionizing pharmacovigilance in #clinicalresearch, from early detection of adverse drug reactions to predictive analytics. The potential of AI is promising new levels of safety and efficiency in #pharmacovigilance. Read the blog to know more. Explore how we can help you with our AI capabilities: https://bit.ly/3JXAwQq #ClinicalResearch #Blogs #ArtificialIntelligence #ClinicalTrials 

🔬Explore how #artificialintelligence and #machinelearning can significantly transform #pharmacovigilance practices. Our comprehensive resource delves into the potential of #AI and #ML technologies in automating adverse event detection, signal detection, and safety monitoring. Read more at: https://hubs.li/Q02tfNNj0 Interested in learning about our Safety and PV solutions? Read more here: https://hubs.li/Q02tfV8T0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #DrugSafety #ArtificialIntelligence #MachineLearning #PatientSafety #Salesforce