Labelling in Pharmacovigilance: CCDS, CCSI, SmPC and USPI Explained | Global PV Regulatory
Автор: Pharmacovigilance Training & knowledge sourcing!
Загружено: 2023-01-06
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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
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#labelling #CCDSvsCCSI #SmPC #InvestigatorBrochure #IB #pharmacovigilance #regulatoryaffairs #CCSI #CCDS
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