-PDF Download- Definition And Application Of Terms For Vaccine Pharmacovigilance EBOOK

Definition and Application of Terms for Vaccine Pharmacovigilance

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher:

Published: 2012

Total Pages: 0

ISBN-13: 9789290360834

This report from the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010). This working group brought together experts from both industrialized and emerging countries representing regulatory agencies, vaccine industry, national and international public health bodies including WHO and CIOMS, academia and clinical care, contributing from their different perspectives. The report covers general terms and definitions for vaccine safety and discusses the application of such harmonized tools in vaccine safety surveillance and studies. As well, the report highlights case definitions for adverse events typically reported for vaccines. The report is addressed to those engaged in vaccine safety data collection and evaluation, and will also make a useful reading for others who want to familiarize themselves with vaccine safety terminology.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

Author: Cobert Barton

Publisher: World Scientific

Published: 2019-04-10

Total Pages: 524

ISBN-13: 9813279168

DOWNLOAD EBOOK →

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Advances in Patient Safety

Author: Kerm Henriksen

Publisher:

Published: 2005

Total Pages: 526

ISBN-13:

DOWNLOAD EBOOK →

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Immunization in Practice

Author: World Health Organization

Publisher: World Health Organization

Published: 2015

Total Pages: 292

ISBN-13: 9241549092

DOWNLOAD EBOOK →

This practical guide contains seven modules targeted at district and health facility staff. It intends to meet the demands to improve immunization services so as to reach more infants in a sustainable way, building upon the experiences of polio eradication. It includes materials adapted from polio on planning, monitoring and use of data to improve the service, that can be used at any level. Revising the manual has been a team exercise. There are contributions from a large number of experts, organizations and institutions. This new edition has seven modules. Several new vaccines that have become more readily available and used in recent years have been added. Also the section on integration with other health interventions has been expanded as exciting opportunities and experiences have become evident in the years following the previous edition. Module 1: Target diseases and vaccines Module 2: The vaccine cold chain Module 3: Ensuring safe injections Module 4: Microplanning for reaching every community Module 5: Managing an immunization session Module 6: Monitoring and surveillance Module 7: Partnering with communities.

Pharmacovigilance Essentials

Author: Mukesh Nandave

Publisher: Springer Nature

Published:

Total Pages: 478

ISBN-13: 9819989493

DOWNLOAD EBOOK →

Framework for Equitable Allocation of COVID-19 Vaccine

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-11-30

Total Pages: 273

ISBN-13: 030968224X

DOWNLOAD EBOOK →

In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

Causality assessment of an adverse event following immunization (AEFI)

Author:

Publisher: World Health Organization

Published: 2019-12-04

Total Pages: 88

ISBN-13: 9241516992

DOWNLOAD EBOOK →

Since the 2013 publication of the “Causality assessment of an adverse event following immunization (AEFI), user manual for the revised WHO classification”, there has been extensive global interest in adopting the new revised causality assessment methodology for vaccine pharmacovigilance systems. WHO provided technical support and helped build capacity in countries of all WHO Regions who wanted to use the revised methodology. Recently, the new methodology has been scientifically evaluated. In April 2017, WHO coordinated an India - Zimbabwe project entitled “Inter-country study to assess the inter-rater reliability of the WHO AEFI causality assessment methodology and the utility of the new WHO AEFI causality assessment software”. The quantitative aspect of the study determined that there was realistic agreement between assessors in their findings. The qualitative aspect of the study identified areas of the methodology that could be made even more robust by the use of more accurate and clearer language, semantics and graphics. In the meanwhile, feedback from surveillance systems and other research studies have shed new evidence on areas such as, “substandard and falsified vaccines”, “immunization anxiety” and “immunization stress-related responses” that need to be incorporated into new guidance documents.

Mann's Pharmacovigilance

Author: Elizabeth B. Andrews

Publisher: John Wiley & Sons

Published: 2014-06-23

Total Pages: 878

ISBN-13: 0470671041

DOWNLOAD EBOOK →

Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Crisis Communication Related to Vaccine Safety

Author: W. H. O. Regional WHO Regional Office for Europe

Publisher: Pan American Health Organization

Published: 2021-02-03

Total Pages: 76

ISBN-13: 9789275123133

DOWNLOAD EBOOK →

Vaccine- and vaccination-related crises require a communication response that is different from the communication strategies used to promote the benefits and importance of vaccines in general. This document presents the technical guidance needed to develop a communication plan that is appropriate for managing crises related to vaccine safety. This guidance will be useful for managers in the areas of immunization and vaccine and vaccination safety. They will also help preparedness and response teams working in safety crises to optimize their communication plans in order to regain, maintain, or strengthen trust in vaccines, vaccination, and immunization programs in general. Each chapter presents a phase (preparation, implementation, and evaluation) with suggested actions and support tools to prepare, implement, and evaluate a communication response in a crisis situation. Also, some sections can also be used to strengthen routine national communication activities such as interaction with media, message generation, spokespeople preparation among others. The current document complements the Manual for the surveillance of events supposedly attributable to vaccination or immunization (ESAVI) in the Region of the Americas. This document is published within the framework of a joint project that aims to promote communication-related to safe vaccination in the Region of the Americas and support health authorities that need to develop a communication plan to manage crises related to vaccine safety. Some of the sections in this publication are based on the guidance documents available in the WHO Regional Office for Europe's virtual library and can be consulted on their website.

Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 396

ISBN-13: 1587634333

DOWNLOAD EBOOK →

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.