Le processus de maîtrise des activités externalisées à impact pharmaceutique au sein d'un établissement pharmaceutique

Le processus de maîtrise des activités externalisées à impact pharmaceutique au sein d'un établissement pharmaceutique PDF Author: Eva Michel
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0

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Book Description
Ce travail traite des moyens mis en oeuvre au sein d'un établissement pharmaceutique afin d'assurer la maîtrise des activités externalisées en lien avec les opérations pharmaceutiques décrites dans le code de la santé publique (articles R5124-36). Aujourd'hui, le recours à la prestation de service est en perpétuelle augmentation au sein des établissements pharmaceutiques qui souhaitent se recentrer sur leur coeur de métier principal et tirer profit de la spécialisation des entreprises pour tendre vers un plus haut niveau de performance. Cependant, le recours à l'externalisation constitue un facteur de risque pour les activités concernées. Afin de tirer profit des avantages de l'utilisation d'un prestataire et que la qualité des produits ainsi que la sécurité des patients ne pâtissent pas de l'externalisation des opérations, il convient de mettre en oeuvre tous les moyens nécessaires à la maîtrise des activités externalisées par l'établissement pharmaceutique. Des processus doivent donc être mis en place au sein des établissements pharmaceutiques afin de s'assurer de l'adéquation du système de management de la qualité du prestataire avec les exigences du cahier des charges et avec les référentiels.

Le processus de maîtrise des activités externalisées à impact pharmaceutique au sein d'un établissement pharmaceutique

Le processus de maîtrise des activités externalisées à impact pharmaceutique au sein d'un établissement pharmaceutique PDF Author: Eva Michel
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0

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Book Description
Ce travail traite des moyens mis en oeuvre au sein d'un établissement pharmaceutique afin d'assurer la maîtrise des activités externalisées en lien avec les opérations pharmaceutiques décrites dans le code de la santé publique (articles R5124-36). Aujourd'hui, le recours à la prestation de service est en perpétuelle augmentation au sein des établissements pharmaceutiques qui souhaitent se recentrer sur leur coeur de métier principal et tirer profit de la spécialisation des entreprises pour tendre vers un plus haut niveau de performance. Cependant, le recours à l'externalisation constitue un facteur de risque pour les activités concernées. Afin de tirer profit des avantages de l'utilisation d'un prestataire et que la qualité des produits ainsi que la sécurité des patients ne pâtissent pas de l'externalisation des opérations, il convient de mettre en oeuvre tous les moyens nécessaires à la maîtrise des activités externalisées par l'établissement pharmaceutique. Des processus doivent donc être mis en place au sein des établissements pharmaceutiques afin de s'assurer de l'adéquation du système de management de la qualité du prestataire avec les exigences du cahier des charges et avec les référentiels.

Maîtrise des prestataires à impact pharmaceutique

Maîtrise des prestataires à impact pharmaceutique PDF Author: Hugo Barbouche
Publisher:
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Category :
Languages : fr
Pages : 0

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Book Description
L'évolution des problématiques des industries pharmaceutiques entraine le recours, de plus en plus important, à l'externalisation de certaines activités pharmaceutiques. Externaliser une activité pharmaceutique permet au laboratoire d'aller rechercher une expertise qu'il ne possède pas en interne, d'optimiser ses ressources mais aussi de se concentrer sur son coeur de métier; c'est un gain d'efficience non négligeable pour certaines activités. Toutefois l'externalisation apporte des problématiques nouvelles : la multiplicité des acteurs et intermédiaires accroit les risques portant sur ces processus. L'augmentation de ces risques impacte directement les clients des industries pharmaceutiques : le patient. Pour encadrer cette problématique, une réglementation stricte sur la maitrise des activités pharmaceutiques externalisées existe. Bien qu'externalisées ces activités pharmaceutiques sont sous la responsabilité du pharmacien responsable. Pour répondre à ces nouveaux enjeux ainsi qu'aux exigences réglementaires, les laboratoires se sont adaptés et ont développés des processus de maitrise des activités externalisées de plus en plus robustes. Ces processus de gestion des activités externalisées se base sur une approche par le risque. Cette thèse traite du processus de maitrise des prestataires à impact pharmaceutique appliqué au sein d'un site exploitant pharmaceutique. Une présentation des différents référentiels s'appliquant à la maitrise des prestataires à impact pharmaceutique est effectuée, ce qui permet de définir un cadre réglementaire. Suite à cela, la démarche de maitrise des prestataires au sein d'un site exploitant pharmaceutique ainsi que les différents outils utilisables sont développés. Cette démarche se base sur le risque. Pour finir, une application pratique est présentée afin d'illustrer ces propos.

Maîtrise de l'externalisation des activités via un processus portant sur la sélection, l'évaluation et le suivi des prestataires, intégrant la notion de gestion du risque qualité

Maîtrise de l'externalisation des activités via un processus portant sur la sélection, l'évaluation et le suivi des prestataires, intégrant la notion de gestion du risque qualité PDF Author: Belaïd Kaouane
Publisher:
ISBN:
Category :
Languages : fr
Pages : 102

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The Body Economic

The Body Economic PDF Author: David Stuckler
Publisher: Basic Books
ISBN: 0465063977
Category : Business & Economics
Languages : en
Pages : 242

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Book Description
Politicians have talked endlessly about the seismic economic and social impacts of the recent financial crisis, but many continue to ignore its disastrous effects on human health—and have even exacerbated them, by adopting harsh austerity measures and cutting key social programs at a time when constituents need them most. The result, as pioneering public health experts David Stuckler and Sanjay Basu reveal in this provocative book, is that many countries have turned their recessions into veritable epidemics, ruining or extinguishing thousands of lives in a misguided attempt to balance budgets and shore up financial markets. Yet sound alternative policies could instead help improve economies and protect public health at the same time. In The Body Economic, Stuckler and Basu mine data from around the globe and throughout history to show how government policy becomes a matter of life and death during financial crises. In a series of historical case studies stretching from 1930s America, to Russia and Indonesia in the 1990s, to present-day Greece, Britain, Spain, and the U.S., Stuckler and Basu reveal that governmental mismanagement of financial strife has resulted in a grim array of human tragedies, from suicides to HIV infections. Yet people can and do stay healthy, and even get healthier, during downturns. During the Great Depression, U.S. deaths actually plummeted, and today Iceland, Norway, and Japan are happier and healthier than ever, proof that public wellbeing need not be sacrificed for fiscal health. Full of shocking and counterintuitive revelations and bold policy recommendations, The Body Economic offers an alternative to austerity—one that will prevent widespread suffering, both now and in the future.

New Frontiers in the Economics of Innovation and New Technology

New Frontiers in the Economics of Innovation and New Technology PDF Author: Cristiano Antonelli
Publisher: Edward Elgar Publishing
ISBN: 1845427920
Category : Technology & Engineering
Languages : en
Pages : 495

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Book Description
This Festschrift explores the truly exceptional breadth and depth of Paul David s work, focusing upon his contributions to the topics of path dependence, the economics of knowledge, and the diffusion of technology. The book consists of 15 papers plus an introduction by the editors and an entertaining postscript by Dominique Foray. . . For economic historians, the papers on path dependence assembled in this book, and particularly the conceptual paper by Antonelli, should be essential reading. Nikolaus Wolf, Economic History Review Recent research on the economics of innovation has acknowledged the importance of path dependence and networks in the evolution of economies and the diffusion of new techniques, products, and processes. These are topics pioneered by Paul A. David, one of the world s leading scholars in the economics of innovation. This outstanding collection provides a fitting tribute to the diversity and depth of Paul David s contributions. The papers included range from simulation models of the evolution of market structure in the presence of innovation, through historical investigations of knowledge networks and empirical analysis of contemporary networks, to the analysis of the diffusion of innovations using simulation and analytic models and of the diffusion of knowledge using patent data. With an emphasis on simulation models, data analysis, and historical evidence, this book will be required reading for researchers in innovation economics and regional development as well as economists, sociologists, and historians of innovation and intellectual property.

The Patient Will See You Now

The Patient Will See You Now PDF Author: Eric Topol
Publisher: Basic Books
ISBN: 0465094473
Category : Medical
Languages : en
Pages : 386

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Book Description
The essential guide by one of America's leading doctors to how digital technology enables all of us to take charge of our health A trip to the doctor is almost a guarantee of misery. You'll make an appointment months in advance. You'll probably wait for several hours until you hear "the doctor will see you now"-but only for fifteen minutes! Then you'll wait even longer for lab tests, the results of which you'll likely never see, unless they indicate further (and more invasive) tests, most of which will probably prove unnecessary (much like physicals themselves). And your bill will be astronomical. In The Patient Will See You Now, Eric Topol, one of the nation's top physicians, shows why medicine does not have to be that way. Instead, you could use your smartphone to get rapid test results from one drop of blood, monitor your vital signs both day and night, and use an artificially intelligent algorithm to receive a diagnosis without having to see a doctor, all at a small fraction of the cost imposed by our modern healthcare system. The change is powered by what Topol calls medicine's "Gutenberg moment." Much as the printing press took learning out of the hands of a priestly class, the mobile internet is doing the same for medicine, giving us unprecedented control over our healthcare. With smartphones in hand, we are no longer beholden to an impersonal and paternalistic system in which "doctor knows best." Medicine has been digitized, Topol argues; now it will be democratized. Computers will replace physicians for many diagnostic tasks, citizen science will give rise to citizen medicine, and enormous data sets will give us new means to attack conditions that have long been incurable. Massive, open, online medicine, where diagnostics are done by Facebook-like comparisons of medical profiles, will enable real-time, real-world research on massive populations. There's no doubt the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result-better, cheaper, and more human health care-will be worth it. Provocative and engrossing, The Patient Will See You Now is essential reading for anyone who thinks they deserve better health care. That is, for all of us.

Body Counts

Body Counts PDF Author: Fondation Marcel Mérieux
Publisher: McGill-Queen's Press - MQUP
ISBN: 9780773529250
Category : Literary Criticism
Languages : en
Pages : 436

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Book Description
In an invigorating comparative and interdisciplinary reconsideration of the role of different types of medical counting, this wide-ranging bilingual volume takes us from the mortality tables of the eighteenth century to the movement for evidence-based medicine in our own day. Culled from the proceedings of La quantification dans les sciences medicales et de la sante: perspective historique held at the Musee Claude-Bernard in France in 2002, Body Counts moves beyond the usual emphasis on public health and clinical medicine to include the central role of numbers in laboratory work and medical instrumentation. Body Counts provides an innovative, historical, and sociological account of the functions of quantification. (McGill University), Sir Iain Chalmers (James Lind Library, Oxford), Nicholas Dodier (INSERM, CNRS, Paris), Michael Donnelly (Bard College), Volker Hess (Humboldt-University), Peter Keating (University of Quebec at Montreal), Ann La Berge (Virginia Tech University), Ilana Lowy (INSERM, CNRS, Paris), Harry M. Marks (Johns Hopkins University), Lion Murard (INSERM, CNRS, Paris), Mark Parascandola (National Cancer Institute, Bethesda, Maryland), Theodore M. Porter (University of California at Los Angeles), Andrea Rusnock (University of Rhode Island), Christiane Sinding (INSERM, CNRS, Paris), and Ulrich Trohler (Institut fur Geschichte der Medizin der Albert-Ludwigs-Universitat)."

Trends in Vital Food and Control Engineering

Trends in Vital Food and Control Engineering PDF Author: Ayman Hafiz Amer Eissa
Publisher:
ISBN: 9789535152682
Category :
Languages : en
Pages : 304

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Book Description
This book is an example of a successful addition to the literature of bioengineering and processing control within the scientific world. The book is divided into twelve chapters covering: selected topics in food engineering, advances in food process engineering, food irradiation, food safety and quality, machine vision, control systems and economics processing. All chapters have been written by renowned professionals working in food engineering and related disciplines.

Engineering the Revolution

Engineering the Revolution PDF Author: Ken Alder
Publisher: University of Chicago Press
ISBN: 0226012654
Category : Technology & Engineering
Languages : en
Pages : 494

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Book Description
Engineering the Revolution documents the forging of a new relationship between technology and politics in Revolutionary France, and the inauguration of a distinctively modern form of the “technological life.” Here, Ken Alder rewrites the history of the eighteenth century as the total history of one particular artifact—the gun—by offering a novel and historical account of how material artifacts emerge as the outcome of political struggle. By expanding the “political” to include conflict over material objects, this volume rethinks the nature of engineering rationality, the origins of mass production, the rise of meritocracy, and our interpretation of the Enlightenment and the French Revolution.

Our Lady of Controversy

Our Lady of Controversy PDF Author: Alicia Gaspar de Alba
Publisher: University of Texas Press
ISBN: 0292726422
Category : Art
Languages : en
Pages : 345

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Book Description
Months before Alma López's digital collage Our Lady was shown at the Museum of International Folk Art in 2001, the museum began receiving angry phone calls from community activists and Catholic leaders who demanded that the image not be displayed. Protest rallies, prayer vigils, and death threats ensued, but the provocative image of la Virgen de Guadalupe (hands on hips, clad only in roses, and exalted by a bare-breasted butterfly angel) remained on exhibition. Highlighting many of the pivotal questions that have haunted the art world since the NEA debacle of 1988, the contributors to Our Lady of Controversy present diverse perspectives, ranging from definitions of art to the artist's intention, feminism, queer theory, colonialism, and Chicano nationalism. Contributors include the exhibition curator, Tey Marianna Nunn; award-winning novelist and Chicana historian Emma Pérez; and Deena González (recognized as one of the fifty most important living women historians in America). Accompanied by a bonus DVD of Alma López's I Love Lupe video that looks at the Chicana artistic tradition of reimagining la Virgen de Guadalupe, featuring a historic conversation between Yolanda López, Ester Hernández, and Alma López, Our Lady of Controversy promises to ignite important new dialogues.