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    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. 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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    Health Canada Drug Approval Pathways 2025: A Complete Guide for Global Pharma Companies In 2025, Health Canada has recast its methodology for overseeing pharmaceuticals, biologics, and innovative therapies. Through advanced Regulatory Affairs Services, the agency’s shifting framework mirrors a worldwide move toward speedier, science-driven, and technology-enabled review processes. For international pharma and biotech organizations, knowledge of these drug approval routes is key to organizing an effective, compliant, and competitive market penetration of Canada. Health Canada's modernization is designed to maintain stringent standards of safety and efficacy while facilitating patient access to new treatments more quickly. The increasing harmonization with global regulators such as the FDA and EMA has made Canada one of the most forward-thinking drug regulatory environments in the world. Therapeutic Products Directorate (TPD) – for pharmaceuticals and medical devices. Biologics and Genetic Therapies Directorate (BGTD) – for biologics, vaccines, and gene or cell-based treatments. The two directorates are responsible for assuring that drugs are of safety, efficacy, and quality standards under the Food and Drugs Act and its supporting regulations. Read the Full blog, to know more : https://resource.ddregpharma.com/blogs/health-canada-drug-approval-pathways-2025-a-complete-guide-for-global-pharma-companies/ 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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