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. 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. . , Unanticipated . 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. Identify new or changing . risks . and take appropriate actions through:. Early . detection . of. Novel pathogens. Variations of old . pathogens . Understand trends and patterns of disease. To inform public health policy: who should be targeted, what interventions are useful, etc.. Regional . Hospital for Automatic Disease Reporting to a District Health Department in Northern Kentucky . Ekaette . Joseph-Isang¹, . Douglas A. . Thoroughman², . Kelly . Giesbrecht³, . Marzieh . Hatamzadeh. 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. 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.”. 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. Clinical and Institutional Disclosure of Adverse Events to Patients Call 1 of 2 Delivered May 21, 2012 updated to reflect directive’s reissue (October 31, 2018) Sponsoring Offices: National Center for Ethics in Health Care 3 FOREWORD ACKNOWLEDGEMENTS OBJECTIVES AND COMPONENTS OF THE UNIT OF VACCINES AND IMMUNIZATION Objectives and priorities of UVIS Immunization system component 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 An overview of routine immunization services in developing countries. Presentation I Outline. Broad overview of Routine Immunization (RI). History of Expanded Program on Immunization (EPI). About the RI vaccines. 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…” . of . Life Among Patients Who Report Adverse Events . while on . Treatment . for . Drug-Resistant . TB in Johannesburg, South Africa.  . Denise Evans, . Tembeka Sineke. , Kate Schnippel, Helena . van .