Definition and Application of Terms for Vaccine Pharmacovigilance - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Definition and Application of Terms for Vaccine Pharmacovigilance write by Council for International Organizations of Medical Sciences (CIOMS). This book was released on 2012. Definition and Application of Terms for Vaccine Pharmacovigilance available in PDF, EPUB and Kindle. 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.
CIOMS Guide to Active Vaccine Safety Surveillance
CIOMS Guide to Active Vaccine Safety Surveillance - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook CIOMS Guide to Active Vaccine Safety Surveillance write by Council for International Organizations of Medical Sciences (CIOMS). This book was released on 2017-04-25. CIOMS Guide to Active Vaccine Safety Surveillance available in PDF, EPUB and Kindle. 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.
Dictionary of Pharmacovigilance
Dictionary of Pharmacovigilance - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Dictionary of Pharmacovigilance write by Amer Alghabban. This book was released on 2004. Dictionary of Pharmacovigilance available in PDF, EPUB and Kindle. 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.
Advances in Patient Safety
Advances in Patient Safety - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Advances in Patient Safety write by Kerm Henriksen. This book was released on 2005. Advances in Patient Safety available in PDF, EPUB and Kindle. v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) write by Barton Cobert. This book was released on 2019-04-09. Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) available in PDF, EPUB and Kindle. 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.Related Link(s)
