PPT-Adverse Events Following Immunization (AEFI) Surveillance –

Reporting and Management Dr Vikas Madaan Senior Programme Manager AEFI Secretariat ITSU Basics of AEFI surveillance Definition Types and categories of AEFI AEFI organization Reporting and Timeliness. phacaspcgccaimae57375formengphp Report events which have a temporal association with a vaccine and which cannot be clearly attributed to other causes A causal relationship does not need to be proven and submitting a report does not imply causality Of Which Form 4 to Use?. Reason for Reporting Unanticipated Problems. “to assure the protection of the rights and welfare of the human subjects”. UTHSC IRB Submission Forms. 4a: Reportable local adverse events. Dee Blumberg, PhD. An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . (21 CFR 312.32).. Adverse Events. An adverse event or suspected adverse reaction is considered “serious” if, in the view of . Rachel Phillips & Victoria Cornelius. Review. “recommended improvements in the accuracy of harm data in RCT reports and a need to standardize practices for reporting.”. Review. “found that methods used to collect adverse event data, the frequency of collection, and the selection criteria used by authors for reporting adverse events vary substantially, and these events are often inadequately reported.”. MODULE 3 Adverse events following immunizationOverviewUnder recommended conditions all vaccines used in national immunization programmes are safe and e31ective if used correctly In practice however no 655 West 12th AvenueVancouver BC V5Z 4R4Tel 6047072548Fax 6047072515wwwbccdccaCommunicable Disease Control ManualChapter 2 Immunization PartAdverse Events Following ImmunizationCommunicable Disease C Outline of Presentation. UIP Scope and Scale. Immunization Coverage trends. Newer Interventions . & future plans in/as. :. Scaling up coverage: Mission . Indradhanush. New Vaccines introduction. Improving Quality:. (. AEFI). Adverse Events Following Immunization. . (AEFI). . The goal of immunization is to protect individuals from specific disease; but may lead to adverse events that require careful monitoring.. IN HEMOPHILIA. Alfonso Iorio, McMaster University,. . Canada. Chair, Data. and Demographics Committee, WFH. Chair, Canadian Bleeding Disorders Registry. PI, Canadian Hemophilia Surveillance Scheme. 112/16/2020 CS321570-H Purpose Sex and Weight of PatientNeedle GaugeNeedle LengthInjection SiteFemale or male fewer than 130 lbsDeltoid muscle of armFemale or male 130Deltoid muscle of armFemale 152 ). 1. * Developed based on the outline of the . “Immunization stress-related response - A manual for program managers and health professionals to prevent, identify and respond to stress-related responses following immunization”. SAHPRA WEBINAR ON ADVERSE EVENTS REPORTING. E MASETI: DEPUTY DIRECTOR – EXPANDED PROGRAM ON IMMUNISATION. NATIONAL DEPARTMENT OF HEALTH. 6 NOVEMBER 2023. 2. SIDE EFFECTS ASSOCIATED WITH VACCINES EXPERIENCED AT NDOH, EPI. Definition- . According to the CIOMS/WHO working group on vaccine pharmacovigilance, . Vaccine . pharmacovigilance is defined as “the science and activities relating to the” . . o . Detection, . Investigator Kick-off Meeting. January 30-31, Clearwater, Florida. Jodie Riley, MISM and Robert Silbergleit. Adverse Events. Adverse Events (AEs) are “. . . any . untoward. medical occurrence in a subject that was not previously identified which does not necessarily have a causal relationship to the study drug…” .