MISE AU PLACE D'UN SYSTEME QUALITE AU CENTRE REGIONAL DE PHARMACOVIGILANCE D'ANGERS PDF Download
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Author: CAROLE.. BENOIST
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: CAROLE.. BENOIST
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
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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.
Author: World Health Organization
Publisher:
ISBN:
Category : Electronic journals
Languages : en
Pages : 534
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Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 1118820142
Category : Medical
Languages : en
Pages : 878
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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: Alan D. Lopez
Publisher: World Bank Publications
ISBN: 0821362631
Category : Medical
Languages : en
Pages : 511
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Book Description
Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
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Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: Irene Papanicolas
Publisher: McGraw-Hill Education (UK)
ISBN: 033524727X
Category : Medical
Languages : en
Pages : 418
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Book Description
International comparison of health system performance has become increasingly popular, made possible by the rapidly expanding availability of health data. It has become one of the most important levers for prompting health system reform. Yet, as the demand for transparency and accountability in healthcare increases, so too does the need to compare data from different health systems both accurately and meaningfully. This timely and authoritative book offers an important summary of the current developments in health system performance comparison. It summarises the current state of efforts to compare systems, and identifies and explores the practical and conceptual challenges that occur. It discusses data and methodological challenges, as well as broader issues such as the interface between evidence and practice. The book draws out the priorities for future work on performance comparison, in the development of data sources and measurement instruments, analytic methodology, and assessment of evidence on performance. It concludes by presenting the key lessons and future priorities, and in doing so offers a rich source of material for policy-makers, their analytic advisors, international agencies, academics and students of health systems.
Author: Charles D. Hepler
Publisher: CRC Press
ISBN: 0203010736
Category : Medical
Languages : en
Pages : 464
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Book Description
Read this book in order to learn: Why medicines often fail to produce the desired result and how such failures can be avoided How to think about drug product safety and effectiveness How the main participants in a medications use system can improve outcomes and how professional and personal values, attitudes, and ethical reasoning fit into
Author: United Nations Publications
Publisher: UN
ISBN: 9789211483499
Category :
Languages : en
Pages : 132
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Book Description
The report presents the latest assessment of global trends in wildlife crime. It includes discussions on illicit rosewood, ivory, rhino horn, pangolin scales, live reptiles, tigers and other big cats, and European eel. The COVID-19 (coronavirus) pandemic has highlighted that wildlife crime is a threat not only to the environment and biodiversity, but also to human health, economic development and security. Zoonotic diseases - those caused by pathogens that spread from animals to humans - represent up to 75% of all emerging infectious diseases. Trafficked wild species and the resulting products offered for human consumption, by definition, escape any hygiene or sanitary control, and therefore pose even greater risks of infection.
Author: J. Edgardo Campos
Publisher: World Bank Publications
ISBN: 0821367269
Category : Business & Economics
Languages : en
Pages : 484
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Book Description
Corruption... How can policymakers and practitioners better comprehend the many forms and shapes that this socialpandemic takes? From the delivery of essential drugs, the reduction in teacher absenteeism, the containment of illegal logging, the construction of roads, the provision of water andelectricity, the international trade in oil and gas, the conduct of public budgeting and procurement, and the management of public revenues, corruption shows its many faces. 'The Many Faces of Corruption' attempts to bring greater clarity to the often murky manifestations of this virulent and debilitating social disease. It explores the use of prototype road maps to identify corruption vulnerabilities, suggests corresponding 'warning signals,' and proposes operationally useful remedial measures in each of several selected sectors and for a selected sampleof cross cutting public sector functions that are particularlyprone to corruption and that are critical to sector performance.Numerous technical experts have come together in this effort to develop an operationally useful approach to diagnosing and tackling corruption. 'The Many Faces of Corruption' is an invaluable reference for policymakers, practitioners, andresearchers engaged in the business of development.
