Gestion des risques qualité liés au transport des médicaments à température ambiante PDF Download

Author: Diana Sor
Publisher:
ISBN:
Category :
Languages : fr
Pages : 228

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Author: Apolline Huerre
Publisher:
ISBN:
Category :
Languages : fr
Pages : 146

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Author: Etienne Bernabeu
Publisher:
ISBN:
Category :
Languages : fr
Pages : 322

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Book Description
La distribution en gros des médicaments à usage humain est une activité pharmaceutique soumise à une réglementation stricte. Le renforcement récent des exigences internationales impose que les médicaments soient transportés dans les mêmes conditions que celles recommandées par l'exploitant pour leur stockage. Cette obligation de maîtrise de la température jusqu'en bout de chaîne se heurte à une mondialisation croissante des échanges de produits pharmaceutiques. En dépit de l'omniprésence des risques d'excursions de température, le pharmacien responsable a le devoir d'assurer le maintien des conditions de transport dans des limites acceptables. Fidèle à son engagement envers la santé publique, il doit également s'appuyer sur une démarche de management de la qualité pour prouver que les médicaments n'ont pas été exposés à des conditions qui pourraient avoir un impact sur leur qualité. Une analyse des risques est donc présentée pour accompagner la gestion des excursions de température pendant la distribution des médicaments. La démarche repose tout d'abord sur l'appréciation des risques pour évaluer la criticité des flux existants. Des solutions sont proposées pour réduire les risques identifiés mais la variabilité du transport impose la mise en place d'une méthodologie, en amont de toute défaillance, qui vise à tolérer certaines excursions. Les outils déployés devront être intégrés dans un système de management de la qualité, élément indispensable à l'amélioration continue de la gestion des excursions de température.

Author: Claire Dauchel
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0

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Un système qualité robuste avec une approche par les risques est primordial pour l'industrie pharmaceutique. Il va contribuer à son adaptation aux changements et à son développement. En outre la gestion des risques qualité va participer à l'amélioration continue des médicaments et garantir la sécurité du patient. Elle doit aussi faciliter un meilleur usage des ressources et participer à l'optimisation des couts nécessaires pour fournir des médicaments dans le monde entier. L'objectif de ce travail est d'optimiser le processus de gestion des risques qualité en place depuis plusieurs années pour qu'il apporte un maximum de valeur à ses clients et utilisateurs. Ceci en proposant des idées novatrices grâce aux concepts et à la philosophie agile. Dans un premier temps, nous avons défini en quoi consiste la gestion des risques et plus précisément des risques qualité et la valeur attendu de ce type de processus. Nous avons notamment décrit un processus intégré de gestion des risques qualité dans une industrie pharmaceutique en présentant ces limites et axes d'amélioration. Dans un deuxième temps, nous avons présenté l'agilité et les différents outils utilisés dans notre démarche. Les résultats de l'exploration de la problématique et les intentions de solutions ainsi que les prochaines étapes à mettre en oeuvre sont présentées dans un troisième temps. Enfin, la perspective d'utiliser de telles méthodes dans d'autres domaines de l'assurance qualité est discutée.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241548371
Category : Business & Economics
Languages : en
Pages : 442

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The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.

Author: Alan D. Lopez
Publisher: World Bank Publications
ISBN: 0821362631
Category : Medical
Languages : en
Pages : 511

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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: Sven Boermeester
Publisher:
ISBN: 9781949677072
Category :
Languages : en
Pages :

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Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.

Author:
Publisher:
ISBN: 9780071623445
Category : Airway (Medicine)
Languages : en
Pages : 588

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"Written by the founders of The Difficult Airway Course: Anesthesia and utilizing an instructive case-based approach, this text/DVD presents all of the leading-edge principles, tools, and procedures of airway assessment and management. The scope of the book encompasses the many airway devices that have been developed since the publication of the first edition, many of which have the potential to markedly enhance airway management. Extensively revised and updated, the second edition of Management of the Difficult and Failed Airway emphasizes how airway management is context-sensitive: included are strategies for treating patients in a range of settings, from prehospital care to the ER, as well as proven techniques for special patient populations. In addition, new chapters have been added to further refresh the book's content and provide you with a solid grasp of the most critical topics in this fast-evolving area. The book's effective organization has been maintained, beginning with the first section's focus on the basic foundations of difficult and failed airway management. The second section reviews must-know airway devices and techniques, while the third part of the text introduces case studies that thoroughly examine the application of these techniques in complex clinical situations. A final section covers the practical considerations, such as difficult airway carts and teaching and simulation in airway management."--Publisher description

Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: World Health Organization
ISBN:
Category : Health & Fitness
Languages : en
Pages : 536

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Evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents four DNA topoisomerase II inhibitors used in the treatment of cancer and an additional three pharmaceutical agents (hydroxyures phenolphthalein and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT) an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus is a transplacental carcinogen in mice. The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT) zalcitabine (ddC) and didanosine (ddI) and the antiherpesvirus drug aciclovir. Of these aciclovir and didanosine could not be classified on the basis of available data. For zidovudine transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine which consistently induces thymic lymphomas in mice resulted in its classification as possibly carcinogenic to humans. The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide teniposide mitoxantrone and amsacrine. Of these etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans. Of the three pharmaceutical agents evaluated in the final monograph hydroxyurea which is widely used in cancer treatment and increasingly in combination with didanosine in HIV infection could not be classified. Phenolphthalein a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.

Author: Jojo Moyes
Publisher: Penguin
ISBN: 1101606371
Category : Fiction
Languages : en
Pages : 385

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From the #1 New York Times bestselling author of The Giver of Stars and the forthcoming Someone Else's Shoes, discover the love story that captured over 20 million hearts in Me Before You, After You, and Still Me. They had nothing in common until love gave them everything to lose . . . Louisa Clark is an ordinary girl living an exceedingly ordinary life—steady boyfriend, close family—who has barely been farther afield than their tiny village. She takes a badly needed job working for ex–Master of the Universe Will Traynor, who is wheelchair bound after an accident. Will has always lived a huge life—big deals, extreme sports, worldwide travel—and now he’s pretty sure he cannot live the way he is. Will is acerbic, moody, bossy—but Lou refuses to treat him with kid gloves, and soon his happiness means more to her than she expected. When she learns that Will has shocking plans of his own, she sets out to show him that life is still worth living. A Love Story for this generation and perfect for fans of John Green’s The Fault in Our Stars, Me Before You brings to life two people who couldn’t have less in common—a heartbreakingly romantic novel that asks, What do you do when making the person you love happy also means breaking your own heart?