contract research and development organizations their role in global product development

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Contract Research And Development Organizations

Author : Shayne C. Gad
ISBN : 146140049X
Genre : Medical
File Size : 87. 16 MB
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The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Concurrent Engineering In The 21st Century

Author : Josip Stjepandić
ISBN : 9783319137766
Genre : Technology & Engineering
File Size : 48. 51 MB
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Presenting the gradual evolution of the concept of Concurrent Engineering (CE), and the technical, social methods and tools that have been developed, including the many theoretical and practical challenges that still exist, this book serves to summarize the achievements and current challenges of CE and will give readers a comprehensive picture of CE as researched and practiced in different regions of the world. Featuring in-depth analysis of complex real-life applications and experiences, this book demonstrates that Concurrent Engineering is used widely in many industries and that the same basic engineering principles can also be applied to new, emerging fields like sustainable mobility. Designed to serve as a valuable reference to industry experts, managers, students, researchers, and software developers, this book is intended to serve as both an introduction to development and as an analysis of the novel approaches and techniques of CE, as well as being a compact reference for more experienced readers.

Global Product Development

Author : Alain Bernard
ISBN : 3642159737
Genre : Technology & Engineering
File Size : 54. 63 MB
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This book of proceedings is the synthesis of all the papers, including keynotes presented during the 20th CIRP Design conference. The book is structured with respect to several topics, in fact the main topics that serve at structuring the program. For each of them, high quality papers are provided. The main topic of the conference was Global Product Development. This includes technical, organizational, informational, theoretical, environmental, performance evaluation, knowledge management, and collaborative aspects. Special sessions were related to innovation, in particular extraction of knowledge from patents.

Collaborators Collaborating

Author : Monica Konrad
ISBN : 9780857454812
Genre : Social Science
File Size : 47. 99 MB
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As bio-capital in the form of medical knowledge, skills and investments moves with greater frequency from its origin in First World industrialized settings to resource-poor communities with weak or little infrastructure, countries with emerging economies are starting to expand new indigenous science bases of their own. The case studies here, from the UK, West Africa, Sri Lanka, Papua New Guinea, Latin America and elsewhere, explore the forms of collaborative knowledge relations in play and the effects of ethics review and legal systems on local communities, and also demonstrate how anthropologically-informed insights may hope to influence key policy debates. Questions of governance in science and technology, as well as ethical issues related to bio-innovation, are increasingly being featured as topics of complex resourcing and international debate, and this volume is a much-needed resource for interdisciplinary practitioners and specialists in medical anthropology, social theory, corporate ethics, science and technology studies.

Research Methods For Operations Management

Author : Christer Karlsson
ISBN : 9781317370093
Genre : Business & Economics
File Size : 54. 55 MB
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Research Methods for Operations Management, second edition is a toolkit of research approaches primarily for advanced students and beginner researchers but also a reference book for any researcher in OM. Many students begin their career in research limited by the one or few approaches taken by their department. The concise, accessible overviews found here equip them with an understanding of a variety of methods and how to use them, enabling them to tailor their research project to their own strengths and goals. The more seasoned researcher will find comprehensive descriptions and analyses on a wide variety of research approaches. This updated and enhanced edition responds to the latest developments in OM, including the growing prominence of services and production of intangible products, and the increasing use of secondary data and of mixed approaches. Alternative research approaches are included and explored to help with the early planning of research. This edition also includes expanded literature review and analysis to guide students towards the next steps in their reading, and more detailed step-by-step advice to tie theory with the researcher’s own practice. Including contributions from an impressive range of the field’s leading thinkers in OM research, this is a guide that no-one embarking on an OM research project should be without.

Review Of Global Competitiveness In The Pharmaceutical Industry Staff Research Study 25

Author :
ISBN : 9781457824777
Genre :
File Size : 69. 66 MB
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Cro Contract Research Organization How Drug Research Is Evolving

Author : Jakob Miera
ISBN : 9783954896981
Genre : Science
File Size : 88. 12 MB
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This book deals in general with mergers & acquisitions in the CRO industry, and more specifically with reasons for M&A, success factors during the M&A process, and why M&A can fail in the Contract Research Organization industry. The pharmaceutical industry faces increasing obstacles in respect to the development and introduction of new medications. That has to do with stricter requirements for admission and sharper controls by authorities. Today, the research and development of a new drug can easily consume more than $800 million and lasting between 10 and 15 years. Due to these facts pharmaceutical companies are looking for an alternative in the drug development process. A popular alternative is the outsourcing or in-house working with Contract Research Organizations (CRO). CRO are specialized in coordination and monitoring of drug development activities. The size of the CRO market in 2012 was around $32 billion and had an estimated market growth of around 9 – 12% for 2013. Increased outsourcing and allocation of R&D money towards CRO reflects a driving force for prospective growth. Contract Research Organizations consider mergers & acquisitions as a vital solution to achieve their objectives.

Vaccines

Author : Stanley A. Plotkin
ISBN : 9781416036111
Genre : Medical
File Size : 23. 6 MB
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Completely revised and updated, this respected reference offers comprehensive and current coverage of every aspect of vaccination--from development to use in reducing disease. It also includes access to a companion Web site for more coverage.

The Pursuit Of New Product Development

Author : Marc Annacchino
ISBN : 0080468322
Genre : Technology & Engineering
File Size : 29. 80 MB
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Product Development begins with an understanding of market needs, within a sound business model, a well-defined financial strategy, and well-thought-out strategic goals. This new book by industry-expert Marc Annacchino, will help the professional engineer, manager, marketer, and all others who must come together as a working team, to better understand their respective roles and responsibilities in that process. Today, speeding the right value proposition to the market can make all the difference between success and failure. With case examples, organizational analysis and project planning tools, this new book looks at that longer, organizational view of product development, and how that view can improve product development cycle times and better take advantage of new market opportunities. It will help the product development team better adapt to change and a dynamic market in today’s global economy through product platform management, and do so rationally and reliably. And it will help product development professionals to look for hidden value in existing product lines as they plan for that change and growth ahead. · Provides product development professionals with the concepts and tools for a more integrated, successful product development cycle · Promotes a more coherent deployment of managers, engineers, marketers, and sales personnel to achieve results within market opportunity in terms of time, cost and performance. · Shows how to better identify and target product value propositions in product line extensions and in securing new markets

Generic Drug Product Development

Author : Isadore Kanfer
ISBN : 9781420020021
Genre : Medical
File Size : 37. 41 MB
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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

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