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 : 50. 97 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 : 75. 69 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.

Handbook Of Research On Trends In Product Design And Development Technological And Organizational Perspectives

Author : Silva, Arlindo
ISBN : 9781615206186
Genre : Computers
File Size : 33. 78 MB
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"This book provides a detailed view on the current issues, trends, challenges, and future perspectives on product design and development, an area of growing interest and increasingly recognized importance for industrial competitiveness and economic growth"--Provided by publisher.

Global Product Development

Author : Alain Bernard
ISBN : 3642159737
Genre : Technology & Engineering
File Size : 47. 49 MB
Format : PDF
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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.

Contract Research And Manufacturing Services Crams In India

Author : Milind Antani
ISBN : 9781908818164
Genre : Medical
File Size : 64. 54 MB
Format : PDF
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The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations

Collaborators Collaborating

Author : Monica Konrad
ISBN : 9780857454812
Genre : Social Science
File Size : 76. 55 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.

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

Author :
ISBN : 9781457824777
Genre :
File Size : 64. 31 MB
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Drug And Biological Development

Author : Ronald Evens
ISBN : 9780387329789
Genre : Medical
File Size : 43. 56 MB
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The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. Format is optimized for education and training of health care professionals, especially fellows in training (MD, PharmD, PhD), at universities. Format of the book is a set of figures, tables and lists, that can become power-point style slides as well, and the detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. Industry and research experts (multidisciplinary ' MD, PharmD, and PhD) are editors and authors. An added CD-ROM (slides only) enhances utility and marketability of book to course directors, providing the highly sought after slides for lectures.

Developing New Contraceptives

Author : Luigi Mastroianni
ISBN : NAP:14119
Genre : Medical
File Size : 44. 17 MB
Format : PDF
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Annotation This report is the work of committees of the National Research Council and the Institute of Medicine. It analyzes the process by which contraceptives are developed and approved for use in the US and suggests ways to change that process to facilitate the development of safer, more effective, more convenient, and more acceptable new contraceptive methods. Now if public policy (taxes) can be rationalized there may be hope for the quality of life in these crowded United States. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com).

Vaccines

Author : Stanley A. Plotkin
ISBN : 9781416036111
Genre : Medical
File Size : 60. 2 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.

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