The Pathway To Operational Excellence In The Pharmaceutical Industry Download Ebook PDF Epub Online

Author : Thomas Friedli
Publisher :
Release : 2010
Page : 365
Category : Drug development
ISBN 13 : 9783871934001
Description :


Neue Technologien, sich wandelnde Geschäftsstrategien, Kostendruck auf Hersteller und Zulieferer, migrierende globale Wertschöpfungsketten sowie neue regulatorische Anforderungen sind die Herausforderungen der Pharmaindustrie. Um in allen Bereichen Exzellenz zu erreichen gilt es, den Fokus auf die Menschen zu richten. Sie planen, bewirken, verbessern und erfinden neue Strategien, erfahren, Systeme und Strukturen. Die Fähigkeit zur Überwindung der inneren Trägheit eines Unternehmens macht den Unterschied. Die höchsten FundE-Ausgaben verzeichneten die Unternehmen, die sich nicht weiter mit einem eingeführten und evaluierten Verfahren beschäftigten. Das beeinträchtigte Innovationen im Produkt- und Substanzbereich. Veränderungen werden an Geschwindigkeit und Umfang zunehmen. Hier setzt die Operational Excellence ein. Dies impliziert, das Herstellungspotenzial zu entwickeln, als Grundlage einzigartiger Geschäftsstrategien. Dazu erforderlich sind Exzellenz in Führung und Management, Methoden und Tools sowie Technologie und Innovation. Zielgruppen:- Pharmazeutische Industrie- Zulieferindustrie- Fachhochschulen / Universitäten- Beratungsunternehmen- Behörden.


Author : Thomas Friedli
Prabir Basu
Publisher : Springer Science & Business Media
Release : 2013-11-26
Page : 541
Category : Business & Economics
ISBN 13 : 3642351611
Description :


Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.​


Author : Thomas Friedli
Bart Bastoen
Publisher :
Release : 2006
Page : 190
Category : Industrial management
ISBN 13 : 9783871933509
Description :


In dem Buch werden die Ergebnisse einer Benchmark-Studie zum Thema "Operational Excellence in der Pharmaindustrie", die von der Universität St. Gallen und der Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e. V. (APV) durchgeführt wurde, zusammengefaßt und ausgewertet. Über 100 Pharma-Produktionsstätten in mehr als 20 europäischen Ländern wurden im Rahmen der Studie hinsichtlich des Ist-Zustandes ihrer Produktionsperformance unter besonderer Berücksichtigung der Anforderungen des "Lean Managements" untersucht. Die Autoren geben eine detaillierte Übersicht über die Studienergebnisse und präsentieren einen umfangreichen Maßnahmenkatalog, mit dessen Hilfe eine Steigerung der Operational Excellence von Pharma-Produktionsanlagen erreicht werden kann. Die Ergebnisse von sieben beispielhaften Fallstudien, die besonders umfangreich analysiert wurden, sowie ein Ausblick auf die wesentlichen sich bereits abzeichnenden technologischen Weiterentwicklungen im Bereich Pharma-Produktion vermitteln dem Leser praxisnahes und hilfreiches Wissen, um Verbesserungspotentiale im eigenen betrieblichem Umfeld analysieren und umsetzen zu können. Führende Pharma-Experten aus den Bereichen Management sowie Forschung & Entwicklung haben dazu beigetragen, das Thema Operational Excellence erstmals aus Sicht der Pharmaindustrie umfassend zu behandeln. Zielgruppen:- Pharmazeutische Industrie- Auftragshersteller- Zulieferindustrie- Anlagenbau- Planungsunternehmen- Consulting-Unternehmen- Universitäten und Fachhochschulen- Behörden (Überwachungsämter).


Author : Holly Fernandez Lynch
I. Glenn Cohen
Publisher : Columbia University Press
Release : 2015-09-08
Page : 528
Category : Business & Economics
ISBN 13 : 0231540078
Description :


In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.


Author : Thomas Friedli
Andreas Mundt
Publisher : Springer
Release : 2014-07-08
Page : 271
Category : Business & Economics
ISBN 13 : 3642341853
Description :


The preceding process of globalization and the continuously rising competitive pressure on manufacturing companies in more developed economies unveiled the limits of classical site-focused optimization approaches. The focus of network optimization shifts ever more towards an integrative view of manufacturing networks, striving for a harmonization of the strategy-, configuration- and coordination levels. This book presents such an integrative approach to the strategic management of manufacturing networks. Besides strategic network requirements, this book discusses the derivation of an optimal global footprint and the optimization of network coordination activities. Special attention is paid to the site roles concept, especially to the concept of 'lead factory'. A large number of up-to-date cases from the producing industry enrich the book and provide the reader with vivid examples for the application of the presented concepts. Hence, this book is a must-read for both practitioners and academic researchers.


Author : Brian K. Nunnally
John S. McConnell
Publisher : CRC Press
Release : 2007-06-13
Page : 224
Category : Medical
ISBN 13 : 9781420054408
Description :


The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.


Author : National Academies of Sciences, Engineering, and Medicine
Health and Medicine Division
Publisher : National Academies Press
Release : 2018-03-01
Page : 234
Category : Medical
ISBN 13 : 0309468086
Description :


Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.


Author : OECD
World Health Organization
Publisher : OECD Publishing
Release : 2019-10-17
Page :
Category :
ISBN 13 : 9264805907
Description :


This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.


Author : Andreas Seiter
Publisher : World Bank Publications
Release : 2010-06-17
Page : 238
Category : Medical
ISBN 13 : 9780821383872
Description :


This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.


Author : Martin Austin
Publisher : CRC Press
Release : 2016-04-08
Page : 202
Category : Business & Economics
ISBN 13 : 1317170598
Description :


Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.


Author : David Berke
Michael E. Kossler
Publisher : John Wiley & Sons
Release : 2015-08-10
Page : 160
Category : Business & Economics
ISBN 13 : 111918794X
Description :


Based on the popular Developing Leadership Talent program offered by the acclaimed Center for Creative Leadership, this important resource offers a nuts-and-bolts framework for putting in place a leadership development system that will attract and retain the best and brightest talent. Step by step, the authors explain how alignment with strategic goals and organizational purpose and effective developmental experiences are the backbone of a successful leadership program. An authoritative and useful book, Developing Leadership Talent is an essential tool for any leadership program.


Author : Taosheng Chen
Sergio Chai
Publisher : BoD – Books on Demand
Release : 2016-11-30
Page : 190
Category : Medical
ISBN 13 : 9535127993
Description :


Drug discovery involves multiple disciplines, technologies, and approaches. This book selects important topics related to drug discovery, including emerging tool (Chapter 1), cutting-edge approaches (Chapters 2, 3, and 4), examples of specific therapeutic area (Chapter 5), quality control in drug development (Chapter 6), and job and career opportunities in the pharmaceutical sector, a topic rarely covered by other books (Chapter 7). This book draws knowledge from experts actively involved in different areas of drug discovery from both industrial and academic settings. We hope that this book will facilitate your efforts in drug discovery.


Author : National Academies of Sciences, Engineering, and Medicine
Health and Medicine Division
Publisher : National Academies Press
Release : 2017-10-28
Page : 482
Category : Medical
ISBN 13 : 0309459540
Description :


Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.


Author : Cenk Undey
Duncan Low
Publisher : CRC Press
Release : 2011-12-07
Page : 327
Category : Medical
ISBN 13 : 1439829454
Description :


As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.


Author : National Academies of Sciences, Engineering, and Medicine
Health and Medicine Division
Publisher : National Academies Press
Release : 2020-01-27
Page : 102
Category : Medical
ISBN 13 : 0309498511
Description :


To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.


Author : David H. Peters
Nhan T. Tran
Publisher : World Health Organization
Release : 2013
Page : 67
Category : Medical
ISBN 13 : 9241506210
Description :


Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.


Author : Institute of Medicine
Board on Health Care Services
Publisher : National Academies Press
Release : 2003-07-01
Page : 191
Category : Medical
ISBN 13 : 9780309133197
Description :


The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.


Author : Stephen Heidari-Robinson
Suzanne Heywood
Publisher : Harvard Business Review Press
Release : 2016-10-25
Page : 256
Category : Business & Economics
ISBN 13 : 1633692248
Description :


A Practical Guide in Five Steps Most executives will lead or be a part of a reorganization effort (a reorg) at some point in their careers. And with good reason—reorgs are one of the best ways for companies to unlock latent value, especially in a changing business environment. But everyone hates them. No other management practice creates more anxiety and fear among employees or does more to distract them from their day-to-day jobs. As a result, reorgs can be incredibly expensive in terms of senior-management time and attention, and most of them fail on multiple dimensions. It’s no wonder companies treat a reorg as a mysterious process and outsource it to people who don’t understand the business. It doesn’t have to be this way. Stephen Heidari-Robinson and Suzanne Heywood, former leaders in McKinsey’s Organization Practice, present a practical guide for successfully planning and implementing a reorg in five steps—demystifying and accelerating the process at the same time. Based on their twenty-five years of combined experience managing reorgs and on McKinsey research with over 2,500 executives involved in them, the authors distill what they and their McKinsey colleagues have been practicing as an “art” into a “science” that executives can replicate—in companies or business units large or small. It isn’t rocket science and it isn’t bogged down by a lot of organizational theory: the five steps give people a simple, logical process to follow, making it easier for everyone—both the leaders and the employees who ultimately determine a reorg’s success or failure—to commit themselves to and succeed in the new organization.


Author : Mark O. George
Publisher : John Wiley & Sons
Release : 2010-01-28
Page : 352
Category : Business & Economics
ISBN 13 : 9780470606568
Description :


Praise for The Lean Six Sigma guide to Doing More with Less "At Frito Lay, we have applied many of the concepts and tools in this book, and we are realizing a five to seven times return on our annual Lean Six Sigma investment." —Tony Mattei, Lean Six Sigma Director, Frito Lay "Ecolab has experienced a sustainable, competitive advantage through Lean Six Sigma. The principles in this book are helping us drive greater value for our share-holders, better service for our customers, and talent development opportunities for our associates." —Jeffrey E. Burt, Vice President and Global Deployment Leader, Lean Six Sigma, Ecolab "This book gives excellent insights into Lean Six Sigma and its strong impact within different industries. We used Lean Six Sigma in numerous process improvement projects, which, in turn, helped to create momentum and set up a process improvement culture. Amid a challenging economic environment, we are accelerating this initiative globally." —Satheesh Mahadevan, Directeur des Processus, Société Générale "Our Lean Six Sigma deployment of the concepts and tools described in this book is transforming our business—with tangible benefits for our employees, customers, suppliers, and shareholders." —Jeffrey Herzfeld, Sr. Vice President and General Manager, Teva Pharmaceuticals USA "We have deployed the holistic Lean Six Sigma strategy described by Mark George across our enterprise. It is providing remarkable returns for Unum." —Bob Best, Chief Operating Officer, Unum "The Lean Six Sigma Guide to Doing More with Less presents a comprehensive view of operations transformation, the approaches required for success, leadership's role, and the competitive advantage that results. Transformational changes are enabling us to do more with less, by investing and working smarter." —Ted Doheny, President and COO, Joy Mining Machinery


Author : John S. Oakland
Amrik Sohal
Publisher : Routledge
Release : 1996
Page : 480
Category : Business & Economics
ISBN 13 : 9780750689250
Description :


Total Quality Management (TQM) is structured around a five part model, with the core of the model being the customer-supplier interface. This book includes case studies which illuminate hands-on application of the theories of TQM within the Pacific Rim region and include: Australia, New Zealand, Fiji, Singapore, Hawaii, Hong Kong and Malaysia.