PPT-Adverse Events Following Immunization

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. 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 OBJECTIVES. Describe Adverse Events, Risks and Problems that can Occur in . H. uman . S. ubjects . R. esearch . C. ompliance with Safety . R. eporting . R. egulations in Clinical Research. Identify Current Systems of Patient Care and Patient Safety in Research. . Zarif Jabbar-Lopez, MBBS, MPH. FY2, East of England Deanery. Visiting Research Fellow, Uppsala Monitoring Centre. Disclosure. No conflicts of interest. The . research leading to these results was conducted as part of the PROTECT consortium (. 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. Program Office. (AIPO). What is AIPO?. AIPO is the Arizona Immunization Program Office. Leads . public health immunization efforts in the . state . Funded by the Centers for Disease Control and Prevention. . . February 15, 2017. Presented by:. Nasrin . Zandkarimi, . M.Ed. . Utah Immunization Program. Understanding Utah School Immunization Rule for Students. Describe the Utah School Immunization Rule and the types of schools for which the Rule applies . (AIPO). What is AIPO?. AIPO is the Arizona Immunization Program Office. Leads . public health immunization efforts in the . state . Funded by the Centers for Disease Control and Prevention. What are our goals?. S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . National Cancer Institute. 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 Problems, and Protocol Deviations. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. 1. Learning Objectives: Adverse Events. The Working Group on Medical Measurements. The 23rd Forum Meeting. Tokyo, Japan. Nov. 23-25, 2016. Jin-. Hai. Yang. Bureau of Standards, Metrology and Inspection. Chinese Taipei. 2. Look Back on 2015’s Presentation. Events. Robert Silbergleit, MD. Adverse Events – . key points. Do not report events EXISTING PRIOR to randomization . (unless there is a change in severity). Report the DIAGNOSIS, not the symptoms:. 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…” .