Labelling in Pharmacovigilance: CCDS, CCSI, SmPC and USPI Explained | PV and Regulatory Interviews
Understand the complex world of safety labelling and expectedness. We explain the differences between the CCDS (Company Core Data Sheet), CCSI (Company Core Safety Information), and regional labels like the SmPC (EU) and USPI (US). This video is a must-watch for Regulatory Affairs and Quality Assurance professionals. Highlights: CCDS vs CCSI: What’s the difference? SmPC requirements for the European Union (EMA) USPI and Investigator Brochures (IB) for Clinical Trials Impact of labelling on Signal Detection and ICSR Expectedness Connect with us for training inquiries: 📧: [email protected] 🌐 Official Website: https://www.globalplacosolutions.com/ Follow us on – 💼 LinkedIn Profile: / shripadarajar 👥 Facebook Page: / 1749144791792270 #labelling #CCDSvsCCSI #SmPC #InvestigatorBrochure #IB #pharmacovigilance #regulatoryaffairs #CCSI #CCDS
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