Post-Market Drug Safety: From ICSRs to Real-World Data Integration in Global Pharmacovigilance Systems
The lifecycle of a medicinal product only starts after approval. After a drug enters the real world, the actual safety profile becomes apparent. Post-marketing pharmacovigilance (PV) involves every patient experience informing us about the product's risks and benefits in different, uncontrolled settings. Ongoing, this is the basis of public health protection and a crucial component of comprehensive Regulatory Affairs, API, and DMF Services that ensure continuous compliance and patient safety.
Historically, Individual Case Safety Reports (ICSRs) have been the pillars of post-market safety monitoring. Manufacturers' reports, patients', and healthcare professionals' reports all give invaluable information about adverse events (AEs). Things are changing. The rise in Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) technologies has seen Real-World Data (RWD) integrated to support and supplement traditional reporting systems.
RWD, derived from electronic health records (EHRs), wearables, patient registries, insurance claims, and digital health platforms, provides a more comprehensive and dynamic picture of medicine use in real-world clinical practice. This change allows regulators and Marketing Authorization Holders (MAHs) to identify safety signals more quickly and place them in context with richer patient insights.
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https://resource.ddregpharma.com/blogs/post-market-drug-safety-from-icsrs-to-real-world-data-integration-in-global-pharmacovigilance-systems/
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https://x.com/DDRegPharmaPost-Market Drug Safety: From ICSRs to Real-World Data Integration in Global Pharmacovigilance Systems
The lifecycle of a medicinal product only starts after approval. After a drug enters the real world, the actual safety profile becomes apparent. Post-marketing pharmacovigilance (PV) involves every patient experience informing us about the product's risks and benefits in different, uncontrolled settings. Ongoing, this is the basis of public health protection and a crucial component of comprehensive Regulatory Affairs, API, and DMF Services that ensure continuous compliance and patient safety.
Historically, Individual Case Safety Reports (ICSRs) have been the pillars of post-market safety monitoring. Manufacturers' reports, patients', and healthcare professionals' reports all give invaluable information about adverse events (AEs). Things are changing. The rise in Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) technologies has seen Real-World Data (RWD) integrated to support and supplement traditional reporting systems.
RWD, derived from electronic health records (EHRs), wearables, patient registries, insurance claims, and digital health platforms, provides a more comprehensive and dynamic picture of medicine use in real-world clinical practice. This change allows regulators and Marketing Authorization Holders (MAHs) to identify safety signals more quickly and place them in context with richer patient insights.
Read the Full blog, to know more :
https://resource.ddregpharma.com/blogs/post-market-drug-safety-from-icsrs-to-real-world-data-integration-in-global-pharmacovigilance-systems/
Follow us on :
Facebook: https://www.facebook.com/DDReg/
LinkedIn: https://www.linkedin.com/company/ddregpharma
Twitter: https://x.com/DDRegPharma
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