Signal Detection in Pharmacovigilance by BioPharmSystems

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Signal Detection in Pharmacovigilance - Process proposed by CIOMS Working Group VIII

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									                 Signal
                                                                                                                               Detection
                                                                                                                               Prioritization
                                                                                                                               Evaluation
                                                                 the detailed process proposed by:
                                                                 Council for International Organizations of Medical Sciences (CIOMS)
                                                                 Working Group VIII




                                                                                               Clinical Trials
                                                                          Individual           Post-marketing Surveillance
                                                                                               Literature Reviews
                                                                          Case Safety
                                                                           Reports
Detection




                                                                                               Company Databases
                                                                                               Monitoring Systems
                                                                            Signal
                                                                           Detection




                                                                Individual Case Review                                             Disproportional
                                       Traditional              Aggregate Analysis                             Data                 Reporting Ratios
                                           PV                   Periodic Reports
                                                                                                               Mining
                                        Methods                                                              Algorithms




                                                                                               Interpret the signal in context
                                                                                                of other relevant sources,
                                                                            Triage of           disease knowledge, biologic
                                                                            Outputs             plausibility, alternative
                                                                                                etiologies, etc.




                                 Non-interventional Studies
                 Additional      Non-clinical Studies                                        Need
                                  Class Analysis
                                                                                             Further
                              
                 Monitored       Other Relevant Information

                   Data                                                                   Investigation?
Prioritization




                                                                        Yes                                          No
                                                                     Impact
                                                                  Assessment
                                                                                                                 Is Signal
                                                                       and
                                                                                                                 Refuted?
                                                                  Prioritization


                                                                                                   Yes                                 No

                                                                                                                                   Monitor if
                                                                                             Close Out                             Signal is
                                                                                                                                  Indeterminate
Evaluation




                                                                                                 Individual Case Review
                                                                                                 Aggregate Analysis
                                                                             Signal              Periodic Reports
                                                                                                 Non-interventional Studies
                                                                           Evaluation            Non-clinical Studies
                                                                                                 Class Analysis
                                                                                                 Other Relevant Information




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