Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher:
ISBN: 9789290360834
Category : Drug Monitoring
Languages : en
Pages : 0
Get Book Here
Book Description
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.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360872
Category : Vaccination
Languages : en
Pages : 0
Get Book Here
Book Description
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.
Author: Kerm Henriksen
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 526
Get Book Here
Book Description
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author: Barton Cobert
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 525
Get Book Here
Book Description
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)
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Get Book Here
Book Description
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.
Author:
Publisher: World Health Organization
ISBN: 9241549092
Category : Medical
Languages : en
Pages : 292
Get Book Here
Book Description
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.
Author: Mukesh Nandave
Publisher: Springer Nature
ISBN: 9819989493
Category :
Languages : en
Pages : 478
Get Book Here
Book Description
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
Get Book Here
Book Description
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 0470671041
Category : Medical
Languages : en
Pages : 878
Get Book Here
Book Description
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.
Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
Get Book Here
Book Description
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
