supply chain management in the drug industry delivering patient value for pharmaceuticals and biologics

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Supply Chain Management In The Drug Industry

Author : Hedley Rees
ISBN : 9780470922842
Genre : Medical
File Size : 54. 44 MB
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This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

Supply Chain Management In The Drug Industry

Author : Hedley Rees
ISBN : 9780470922842
Genre : Medical
File Size : 82. 33 MB
Format : PDF
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Supply Chain Management In The Drug Industry

Author : Hedley Rees
ISBN : 9780470920534
Genre : Medical
File Size : 37. 42 MB
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Supply Chain In The Pharmaceutical Industry

Author : Rob Whewell
ISBN : 9781317048336
Genre : Business & Economics
File Size : 80. 48 MB
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The pharmaceutical and healthcare industry is hugely complex because it involves so many markets, products, processes and intermediaries. It is also heavily regulated, global, and used by everyone at some stage in their life. No wonder the supply chain for delivery of healthcare services is often fragmented and understood only in discrete sections. Changes in one area impact upon the others, and environmental factors such as pricing, regulatory change or actions by competitors impact the whole supply chain in ways that are not easily understood or managed. Accelerating technology, the commoditization of healthcare, increasing demands from ageing populations all influence the approach that suppliers of pharmaceutical products and services worldwide need to take if they are to design and manage an effective supply chain that will be capable of: exploiting their intellectual property in a sustainable way; providing safe and continuous provision of drugs or devices; and sustaining with resilience, yet still be flexible and cost efficient. Supply Chain in the Pharmaceutical Industry offers the basis for organizations to develop their own blueprint for managing the opportunities and threats to the pharmaceutical supply chain. Using examples from companies and markets across the world Rob Whewell offers a very vivid picture of the developing trends for pharmaceutical companies; the customers and markets they serve and points to some of the elements that underpin sustainable pharmaceutical strategies. The current global banking and financial crisis illustrates the important role played by regulation. The healthcare industry is similar in scope, and complexity, yet the implications of error are worse - life threatening. This review of key industry parameters will provide senior executives in the industry and policy makers in healthcare with a broad perspective of the issues and illustrates an understanding of the task at hand.

Pharmaceutical Operations Management

Author : Pankaj Mohan
ISBN : 9780071472494
Genre : Business & Economics
File Size : 55. 97 MB
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This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

Handbook Of Integrated Risk Management In Global Supply Chains

Author : Panos Kouvelis
ISBN : 9781118115794
Genre : Business & Economics
File Size : 52. 14 MB
Format : PDF
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A comprehensive, one-stop reference for cutting-edge research in integrated risk management, modern applications, and best practices In the field of business, the ever-growing dependency on global supply chains has created new challenges that traditional risk management must be equipped to handle. Handbook of Integrated Risk Management in Global Supply Chains uses a multi-disciplinary approach to present an effective way to manage complex, diverse, and interconnected global supply chain risks. Contributions from leading academics and researchers provide an action-based framework that captures real issues, implementation challenges, and concepts emerging from industry studies.The handbook is divided into five parts: Foundations and Overview introduces risk management and discusses the impact of supply chain disruptions on corporate performance Integrated Risk Management: Operations and Finance Interface explores the joint use of operational and financial hedging of commodity price uncertainties Supply Chain Finance discusses financing alternatives and the role of financial services in procurement contracts; inventory management and capital structure; and bank financing of inventories Operational Risk Management Strategies outlines supply risks and challenges in decentralized supply chains, such as competition and misalignment of incentives between buyers and suppliers Industrial Applications presents examples and case studies that showcase the discussed methodologies Each topic's presentation includes an introduction, key theories, formulas, and applications. Discussions conclude with a summary of the main concepts, a real-world example, and professional insights into common challenges and best practices. Handbook of Integrated Risk Management in Global Supply Chains is an essential reference for academics and practitioners in the areas of supply chain management, global logistics, management science, and industrial engineering who gather, analyze, and draw results from data. The handbook is also a suitable supplement for operations research, risk management, and financial engineering courses at the upper-undergraduate and graduate levels.

Fundamentals Of Supply Chain Theory

Author : Lawrence V. Snyder
ISBN : 9780470521304
Genre : Business & Economics
File Size : 21. 70 MB
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An authoritative, quantitative approach to supply chain management Addressing the need for the study of supply chain management to evolve at the same pace as it's real-world practice, Fundamentals of Supply Chain Theory presents the methodology and foundations of the topic and also demonstrates how recent developments build upon classic models. The authors focus on strategic and tactical aspects of supply chain management, covering a broad range of topics from forecasting, inventory management, and facility location to process flexibility, contracting, and auctions. Key mathematical models for optimizing the design, operation, and evaluation of supply chains are presented as well as models currently emerging from the research frontier. Following a thorough introduction, the book delves into a discussion of centralized models, including: Forecasting and demand modeling Deterministic inventory models Stochastic inventory models Multi-Echelon inventory models Processes for dealing with uncertainty in inventory optimization and facility location Facility location models Process flexibility In addition, the authors present decentralized models that involve multiple parties with independent, conflicting objectives, covering topics such as: The bullwhip effect Supply chain contracts Auctions Each chapter concludes with a set of problems that challenge readers to understand, interpret, and extend the discussed models and algorithms. In addition, extensive appendices provide guidance on writing proofs and also outline helpful formulas related to probability theory, calculus, and algebra. Extensively class-tested to ensure an easy-to-follow presentation, Fundamentals of Supply Chain Theory is a suitable book for business and engineering courses on supply chain management at the graduate level. The book also serves as an authoritative reference for academics and practitioners working in the areas of operations research, business, management science, and industrial engineering. This book was named the 2011 Joint Publishers Book of the Year by the Institute of Industrial Engineers. You can also follow Fundamentals of Supply Chain Theory on Twitter.

Guidebook For Drug Regulatory Submissions

Author : Sandy Weinberg
ISBN : 9780470456170
Genre : Medical
File Size : 42. 16 MB
Format : PDF, Kindle
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Destined to become every regulatory director's essential desktop companion rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

The Business Of Healthcare Innovation

Author : Lawton R. Burns
ISBN : 0521838983
Genre : Business & Economics
File Size : 32. 57 MB
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The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

Conflict Of Interest In Medical Research Education And Practice

Author : Committee on Conflict of Interest in Medical Research, Education, and Practice
ISBN : 9780309131889
Genre : Medical
File Size : 88. 75 MB
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Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

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