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.

This guide offers a practical step-by-step approach and algorithm to aid immunization professionals and decision-makers in determining the best course of action if additional vaccine safety data is needed. The guide provides a structured process for evaluating whether significant knowledge gaps exist, whether passive safety surveillance is adequate, and if not, methods for and practical aspects of conducting active vaccine safety surveillance. The guide also includes an essential vaccine information source list for evaluating the extent of data resources and several case studies for review. With more vaccine solutions available and opportunities for earlier availability of new vaccine products in resource-limited countries (e.g. vaccines against rotavirus, human papillomavirus or pneumococci) as well as new products that address diseases endemic in those countries only (e.g. malaria, dengue among others), generating reliable data about specific safety concerns is becoming a priority for all countries. This CIOMS publication--more than any other in recent history--has focused on the special needs of the country level organizations responsible for developing strategies and implementing new vaccination programs into resource-limited environments.

Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions, thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use. As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms. Examples include: Absolute Risk Increase (ARI), Bayesian Confidence Propagation Neural Network (BCPNN), Confounding Factor, Case narrative, Causality Assessment, Company Core Safety Information (CCSI), Data mining, 15-day report, Rechallenge, Directive 2001/83/EC, EU Birth Date, Expert report, FDA Form 1639, Historical control, Number Needed to Harm, Toxikinetics, Post-Marketing Surveillance, Qualified Person, Source Data Verification (SDV), Spontaneous Reporting, Vaccine Adverse Event Reporting System (VAERS), Warning Letter, Product Withdrawal.

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

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.

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.

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.