Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
href="#ulink_d5632163-5bb0-5c98-bfee-5989c0182e3e"> Introduction
CIOMS I (1990): International Reporting of Adverse Drug Reactions
CIOMS II (1992): International Reporting of Periodic Drug-Safety Update Summaries
CIOMS IV (1998): Benefit–Risk Balance for Marketed Drugs: Evaluating Safety Signals
CIOMS V (2001): Current Challenges in Pharmacovigilance: Pragmatic Approaches
CIOMS VI (2005): Management of Safety Information from Clinical Trials
Regulatory Reporting and Communications of Safety Information from Clinical Trials
CIOMS VII (2006): Development Safety Update Report (DSUR)
CIOMS IX (2014): Practical Approaches to Risk Minimization for Medicinal Products
CIOMS X (2016): Evidence Synthesis and Meta-analysis
CIOMS (2017): Guide to Active Vaccine Safety Surveillance
FDA Adverse Event Reporting System
General Practice Research Database and Clinical Practice Research Datalink
Other Registries and Databases
Chapter 14Information Technology, Databases, and Computers
Required Safety Database Functionality
Vendor Support and Information Technology Issues
Clinical Data Interchange Consortium