Cioms Guide To Active Vaccine Safety Surveillance

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CIOMS Guide to Active Vaccine Safety Surveillance

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360872
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis CIOMS Guide to Active Vaccine Safety Surveillance by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book CIOMS Guide to Active Vaccine Safety Surveillance written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-04-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Cioms Guide to Vaccine Safety Communication

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher :
ISBN 13 : 9789290360919
Total Pages : 0 pages
Book Rating : 4.3/5 (69 download)

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Book Synopsis Cioms Guide to Vaccine Safety Communication by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book Cioms Guide to Vaccine Safety Communication written by Council for International Organizations of Medical Sciences (CIOMS) and published by . This book was released on 2018-01-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The CIOMS Guide to Vaccine Safety Communication provides an overview of strategic communication issues faced by medicines regulators, those responsible for vaccination policies and programs and other stakeholders including: (1) the launch of newly-developed vaccines for the first time to market, (2) the introduction of current or underutilized vaccines into new countries, regions, or populations, and (3) the handling of any new safety issue arising during the life-cycle of a vaccine. The Guide sources from existing guidance documents and compiles recommendations relevant from a regulatory perspective, providing a common ground in a way that has not been achieved otherwise at a global level. It stresses the fundamental importance of regulatory bodies having a system in place with skilled persons who can efficiently run vaccine safety communication in collaboration with stakeholders. It presents information and examples with color-coding for quick access to three levels of guidance and offers a CIOMS template to use to create a Vaccine Safety Communication Plan.

COVID-19 vaccines

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 924001828X
Total Pages : 232 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis COVID-19 vaccines by : World Health Organization

Download or read book COVID-19 vaccines written by World Health Organization and published by World Health Organization. This book was released on 2020-12-22 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Definition and Application of Terms for Vaccine Pharmacovigilance

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher :
ISBN 13 : 9789290360834
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Definition and Application of Terms for Vaccine Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book Definition and Application of Terms for Vaccine Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Aspects of Signal Detection in Pharmacovigilance

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
ISBN 13 : 9789290360827
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Approaches to Risk Minimisation for Medicinal Products

Author : World Health Organization
Publisher :
ISBN 13 : 9789290360841
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Practical Approaches to Risk Minimisation for Medicinal Products by : World Health Organization

Download or read book Practical Approaches to Risk Minimisation for Medicinal Products written by World Health Organization and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

International Ethical Guidelines for Health-Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Crisis Communication Related to Vaccine Safety

Author : W. H. O. Regional WHO Regional Office for Europe
Publisher : Pan American Health Organization
ISBN 13 : 9789275123133
Total Pages : 76 pages
Book Rating : 4.1/5 (231 download)

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Book Synopsis Crisis Communication Related to Vaccine Safety by : W. H. O. Regional WHO Regional Office for Europe

Download or read book Crisis Communication Related to Vaccine Safety written by W. H. O. Regional WHO Regional Office for Europe and published by Pan American Health Organization. This book was released on 2021-02-03 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Evidence Synthesis and Meta-analysis for Drug Safety

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360858
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Evidence Synthesis and Meta-analysis for Drug Safety by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book Evidence Synthesis and Meta-analysis for Drug Safety written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.

SMQs

Author : Cioms
Publisher :
ISBN 13 : 9789290360773
Total Pages : 96 pages
Book Rating : 4.3/5 (67 download)

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Book Synopsis SMQs by : Cioms

Download or read book SMQs written by Cioms and published by . This book was released on 2004-01-01 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this publication is to brief drug regulatory authorities, scientific institutions and pharmaceutical companies worldwide about the development, purpose and appropriate use of Standardized MedDRA Queries (SMQs) in drug surveillance. Two papers in this publication are to assist in the rational use of search queries in the identification and retrieval of potentially relevant individual case safety reports from a database and to harmonize presentation of search results. It also includes examples to illustrate the structure and content of end product.

Drug Surveillance

Author : Zbigniew Bańkowski
Publisher : World Health Organization
ISBN 13 :
Total Pages : 214 pages
Book Rating : 4.:/5 (47 download)

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Book Synopsis Drug Surveillance by : Zbigniew Bańkowski

Download or read book Drug Surveillance written by Zbigniew Bańkowski and published by World Health Organization. This book was released on 1994 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.

Global vaccine safety blueprint 2.0 (GVSB2.0) 2021-2023

Author :
Publisher : World Health Organization
ISBN 13 : 9240036962
Total Pages : 58 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Global vaccine safety blueprint 2.0 (GVSB2.0) 2021-2023 by :

Download or read book Global vaccine safety blueprint 2.0 (GVSB2.0) 2021-2023 written by and published by World Health Organization. This book was released on 2021-11-17 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:

COVID-19 vaccines

Author :
Publisher : World Health Organization
ISBN 13 : 9240032789
Total Pages : 264 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis COVID-19 vaccines by :

Download or read book COVID-19 vaccines written by and published by World Health Organization. This book was released on 2021-08-04 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials

Author : World Health Organization
Publisher : WHO
ISBN 13 : 9789290360803
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials by : World Health Organization

Download or read book Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials written by World Health Organization and published by WHO. This book was released on 2006 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regular and timely review appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development program is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognized thoughtfully assessed and appropriately communicated to all interested stakeholders to support the safety of clinical trial subjects. Although regulatory authorities currently require the submission of a periodic safety report during the conduct of clinical trials, there are substantial differences in the format content and timing of the different reports. The CIOMS VII Working group is proposing in this new publication an internationally harmonized document namely the Development Safety Update Report (DSUR) that is modeled after the Periodic Safety Update Report (PSUR) for marketed products. It presents the general principles behind the preparation and use of the DSUR and a model DSUR. The model is illustrated with sample fictitious DSURs for a commercial and non-commercial (trial-specific) sponsor.

Advances in Patient Safety

Author : Kerm Henriksen
Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)

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Book Synopsis Advances in Patient Safety by : Kerm Henriksen

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Digital Contact Tracing for Pandemic Response

Author : Jeffrey P. Kahn
Publisher : Johns Hopkins University Press
ISBN 13 : 142144061X
Total Pages : 156 pages
Book Rating : 4.4/5 (214 download)

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Book Synopsis Digital Contact Tracing for Pandemic Response by : Jeffrey P. Kahn

Download or read book Digital Contact Tracing for Pandemic Response written by Jeffrey P. Kahn and published by Johns Hopkins University Press. This book was released on 2020-05-29 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: As nations race to hone contact-tracing efforts, the world's experts consider strategies for maximum transparency and impact. As public health professionals around the world work tirelessly to respond to the COVID-19 pandemic, it is clear that traditional methods of contact tracing need to be augmented in order to help address a public health crisis of unprecedented scope. Innovators worldwide are racing to develop and implement novel public-facing technology solutions, including digital contact tracing technology. These technological products may aid public health surveillance and containment strategies for this pandemic and become part of the larger toolbox for future infectious outbreak prevention and control. As technology evolves in an effort to meet our current moment, Johns Hopkins Project on Ethics and Governance of Digital Contact Tracing Technologies—a rapid research and expert consensus group effort led by Dr. Jeffrey P. Kahn of the Johns Hopkins Berman Institute of Bioethics in collaboration with the university's Center for Health Security—carried out an in-depth analysis of the technology and the issues it raises. Drawing on this analysis, they produced a report that includes detailed recommendations for technology companies, policymakers, institutions, employers, and the public. The project brings together perspectives from bioethics, health security, public health, technology development, engineering, public policy, and law to wrestle with the complex interactions of the many facets of the technology and its applications. This team of experts from Johns Hopkins University and other world-renowned institutions has crafted clear and detailed guidelines to help manage the creation, implementation, and application of digital contact tracing. Digital Contact Tracing for Pandemic Response is the essential resource for this fast-moving crisis. Contributors: Joseph Ali, JD; Anne Barnhill, PhD; Anita Cicero, JD; Katelyn Esmonde, PhD; Amelia Hood, MA; Brian Hutler, Phd, JD; Jeffrey P. Kahn, PhD, MPH; Alan Regenberg, MBE; Crystal Watson, DrPH, MPH; Matthew Watson; Robert Califf, MD, MACC; Ruth Faden, PhD, MPH; Divya Hosangadi, MSPH; Nancy Kass, ScD; Alain Labrique, PhD, MHS, MS; Deven McGraw, JD, MPH, LLM; Michelle Mello, JD, PhD; Michael Parker, BEd (Hons), MA, PhD; Stephen Ruckman, JD, MSc, MAR; Lainie Rutkow, JD, MPH, PhD; Josh Sharfstein, MD; Jeremy Sugarman, MD, MPH, MA; Eric Toner, MD; Mar Trotochaud, MSPH; Effy Vayena, PhD; Tal Zarsky, JSD, LLM, LLB