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Project Management For Pharmaceutical Industry
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Book Synopsis Project Management for the Pharmaceutical Industry by : Laura Brown
Download or read book Project Management for the Pharmaceutical Industry written by Laura Brown and published by Routledge. This book was released on 2016-04-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.
Book Synopsis Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries by : Pete Harpum
Download or read book Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries written by Pete Harpum and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
Book Synopsis Application of Project Management Principles to the Management of Pharmaceutical R&D Projects by : Thomas Catalano
Download or read book Application of Project Management Principles to the Management of Pharmaceutical R&D Projects written by Thomas Catalano and published by Springer Nature. This book was released on 2020-11-05 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dr. Catalano has for the last ten years been doing consulting for the Pharmaceutical Industry. During his consulting he discovered that small businesses such as, generic, startups, and virtual companies do not have the budget or the resources to apply the computer software utilized in project management and therefore do not apply project management principles in their business model. This reduces their effectiveness and increases their operating cost. Application of Project Management Principles to the Management of Pharmaceutical R&D Projects is presented as a paper-based system for completing all the critical activities needed apply the project management system. This will allow these small business to take advantage of the project management principles and gain all the advantages of the system. This book will be beneficial for beginners to understand the concepts of project management and for small pharmaceutical companies to apply the principles of project management to their business model.
Book Synopsis Pharmaceutical and Biomedical Project Management in a Changing Global Environment by : Scott D. Babler
Download or read book Pharmaceutical and Biomedical Project Management in a Changing Global Environment written by Scott D. Babler and published by John Wiley & Sons. This book was released on 2011-01-06 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.
Book Synopsis Project Management for Healthcare by : David Shirley
Download or read book Project Management for Healthcare written by David Shirley and published by CRC Press. This book was released on 2011-04-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a growing number of healthcare organizations implement project management principles to improve cost and service efficiencies, they are in desperate need of resources that illustrate the project management needs of today’s healthcare professional. Project Management for Healthcare fills this need. Using easy-to-follow language, it explains how the time-tested principles of project management can help maximize limited resources and ensure the highest possible quality of care. Exploring the discipline of project management from the perspective of the healthcare environment, the book dissects the project process and provides the tools and techniques required to successfully plan, execute, and control any healthcare-based project. From identifying stakeholders to constructing a project plan, it covers the spectrum of project planning activities. Complete with chapter summaries, exercises, hints, review questions, and case studies, it illustrates applications across a range of healthcare settings. Explains how to utilize the project plan to execute projects within budget, schedule, and quality objectives Covers program management as it relates to healthcare Addresses the interaction between healthcare and information technology Presents best practices from the pharmaceutical and medical equipment industries—that can easily be adapted to any healthcare setting Because most healthcare personnel will inevitably have to work with program management and need to interact with pharmaceutical companies and medical device manufacturers, the book provides an inside look at the processes and best practices used to bring products to market in these industries. Explaining how to adapt these processes to drive down costs and improve the quality of care in any healthcare setting, the book includes a case study of a medical facility that illustrates the proper application of the tools and techniques needed to manage healthcare projects effectively and efficiently.
Book Synopsis Generic Drug Development Project Management by : Sandeep Narayan Patil, PMP
Download or read book Generic Drug Development Project Management written by Sandeep Narayan Patil, PMP and published by Notion Press. This book was released on 2021-04-17 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
Book Synopsis Pharmaceutical Lifecycle Management by : Tony Ellery
Download or read book Pharmaceutical Lifecycle Management written by Tony Ellery and published by John Wiley & Sons. This book was released on 2012-06-05 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.
Book Synopsis Polymorphism in the Pharmaceutical Industry by : Rolf Hilfiker
Download or read book Polymorphism in the Pharmaceutical Industry written by Rolf Hilfiker and published by John Wiley & Sons. This book was released on 2019-01-04 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development" highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.
Book Synopsis Implementing Project Portfolio Management by : Dr. Panos Chatzipanos
Download or read book Implementing Project Portfolio Management written by Dr. Panos Chatzipanos and published by Project Management Institute. This book was released on 2018-10-18 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing Project Portfolio Management addresses the "how-tos" of portfolio management. It is designed for three primary audience groups: Business Executives, Portfolio Leaders and Practitioners, and Portfolio Thinkers. The authors provide insights on how to apply the performance management domains covered in the standard that are in practice today by introducing tools and templates into their discussion. Far-reaching in its impact on portfolio management practitioners, thinkers, stakeholders, and the wider project management community, this guide envisions the continued transformation of portfolio management with the changing needs of organizations and advances in technology.
Book Synopsis Value Creation in the Pharmaceutical Industry by : Alexander Schuhmacher
Download or read book Value Creation in the Pharmaceutical Industry written by Alexander Schuhmacher and published by John Wiley & Sons. This book was released on 2016-04-11 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.
Book Synopsis Project Management, Planning and Control by : Albert Lester
Download or read book Project Management, Planning and Control written by Albert Lester and published by Butterworth-Heinemann. This book was released on 2007 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fifth edition provides a comprehensive resource for project managers. It describes the latest project management systems that use critical path methods.
Book Synopsis Applying Lean Six Sigma in the Pharmaceutical Industry by : Bikash Chatterjee
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.
Book Synopsis Agile Project Management with Scrum by : Ken Schwaber
Download or read book Agile Project Management with Scrum written by Ken Schwaber and published by Microsoft Press. This book was released on 2004-02-11 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rules and practices for Scrum—a simple process for managing complex projects—are few, straightforward, and easy to learn. But Scrum’s simplicity itself—its lack of prescription—can be disarming, and new practitioners often find themselves reverting to old project management habits and tools and yielding lesser results. In this illuminating series of case studies, Scrum co-creator and evangelist Ken Schwaber identifies the real-world lessons—the successes and failures—culled from his years of experience coaching companies in agile project management. Through them, you’ll understand how to use Scrum to solve complex problems and drive better results—delivering more valuable software faster. Gain the foundation in Scrum theory—and practice—you need to: Rein in even the most complex, unwieldy projects Effectively manage unknown or changing product requirements Simplify the chain of command with self-managing development teams Receive clearer specifications—and feedback—from customers Greatly reduce project planning time and required tools Build—and release—products in 30-day cycles so clients get deliverables earlier Avoid missteps by regularly inspecting, reporting on, and fine-tuning projects Support multiple teams working on a large-scale project from many geographic locations Maximize return on investment!
Book Synopsis Therapeutic Risk Management of Medicines by : Stephen J. Mayall
Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. - An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines - A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) - A comprehensive guide for performing risk management more effectively throughout a product's life-cycle
Book Synopsis Business Development for the Biotechnology and Pharmaceutical Industry by : Martin Austin
Download or read book Business Development for the Biotechnology and Pharmaceutical Industry written by Martin Austin and published by CRC Press. This book was released on 2016-04-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Book Synopsis Project Management by : Harold Kerzner
Download or read book Project Management written by Harold Kerzner and published by John Wiley & Sons. This book was released on 2013-01-22 with total page 549 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new edition of the most popular book of project management case studies, expanded to include more than 100 cases plus a "super case" on the Iridium Project Case studies are an important part of project management education and training. This Fourth Edition of Harold Kerzner's Project Management Case Studies features a number of new cases covering value measurement in project management. Also included is the well-received "super case," which covers all aspects of project management and may be used as a capstone for a course. This new edition: Contains 100-plus case studies drawn from real companies to illustrate both successful and poor implementation of project management Represents a wide range of industries, including medical and pharmaceutical, aerospace, manufacturing, automotive, finance and banking, and telecommunications Covers cutting-edge areas of construction and international project management plus a "super case" on the Iridium Project, covering all aspects of project management Follows and supports preparation for the Project Management Professional (PMP®) Certification Exam Project Management Case Studies, Fourth Edition is a valuable resource for students, as well as practicing engineers and managers, and can be used on its own or with the new Eleventh Edition of Harold Kerzner's landmark reference, Project Management: A Systems Approach to Planning, Scheduling, and Controlling. (PMP and Project Management Professional are registered marks of the Project Management Institute, Inc.)
