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Search results with tag "Periodic safety update reports"
E 2 C (R1) Clinical Safety Data Management: …
www.ema.europa.euClinical Safety Data Management: Periodic Safety Update Reports for Marketed ... All relevant clinical and non-clinical safety data should cover only the period of ...
CLINICAL SAFETY DATA MANAGEMENT: PERIODIC …
www.ikev.org213 _____3cc14a clinical safety data management: periodic safety update reports for marketed
Periodic Safety Update Report (PSUR)
www.bsigroup.comThe Periodic Safety Update Report (PSUR) 9 PSUR The PSUR can point to other documentation such as detailed vigilance reports, Post Market Clinical Follow-up (PMCF) Evaluation Reports, etc. but the PSUR must contain sufficient detail to allow for independent assessment and conclusions to be drawn. The aim of the PSUR is not to