Contract Research and Development Organizations PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Contract Research and Development Organizations PDF full book. Access full book title Contract Research and Development Organizations by Shayne C. Gad. Download full books in PDF and EPUB format.
Author: Shayne C. Gad
Publisher: Springer Science & Business Media
ISBN: 146140049X
Category : Medical
Languages : en
Pages : 213
Get Book Here
Book Description
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.
Author: T. Kono
Publisher: Springer
ISBN: 0230599389
Category : Business & Economics
Languages : en
Pages : 280
Get Book Here
Book Description
New product development is not just about creating successful new products. This book presents a blend of cases, original survey research and theory to show the principles used by successful firms in developing new products and pruning those that hold the company back.
Author: John Stark
Publisher: Springer Science & Business Media
ISBN: 1846289157
Category : Technology & Engineering
Languages : en
Pages : 224
Get Book Here
Book Description
Based on interviews with top executives from companies of different sizes and in different industries, this book explains the benefits and challenges of Global Product Development. "Global Product" provides examples from many companies, draws conclusions about best practices, and shows how to manage the innovation, development and support of Global Products. The author is the President of John Stark Associates, a leading service provider in the Product Lifecycle Management (PLM) market, and has published numerous articles and books in the field.
Author: Shayne C. Gad
Publisher: Springer Science & Business Media
ISBN: 146140049X
Category : Medical
Languages : en
Pages : 213
Get Book Here
Book Description
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.
Author: Kim B. Clark
Publisher: Harvard Business Press
ISBN: 9780875842455
Category : Business & Economics
Languages : en
Pages : 409
Get Book Here
Book Description
This book is the culmination of six years of research conducted at the Harvard Business School on how different manufacturing firms around the world approach the development of new products. Its principal focus is the impact of strategy, organization, and management on this critical component of business strategy.
Author: Ulrich Jürgens
Publisher: Springer Science & Business Media
ISBN: 366204255X
Category : Technology & Engineering
Languages : en
Pages : 467
Get Book Here
Book Description
Prof. Jürgens is renowned for his scientific work in such fields as human resources, work organization and organization of production and development, especially for automotive industries. In this publication, authors from different countries discuss models of integration in development and production as realized in practice. Of interest to those practitioners who need to develop benchmarks for their own development and production.
Author: Anil Mital
Publisher: Elsevier
ISBN: 0128001909
Category : Technology & Engineering
Languages : en
Pages : 539
Get Book Here
Book Description
Product development teams are composed of an integrated group of professionals working from the nascent stage of new product planning through design creation and design review and then on to manufacturing planning and cost accounting. An increasingly large number of graduate and professional training programs are aimed at meeting that need by creating a better understanding of how to integrate and accelerate the entire product development process. This book is the perfect accompaniment and a comprehensive guide. The second edition of this instructional reference work presents invaluable insight into the concurrent nature of the multidisciplinary product development process. It can be used in the traditional classroom, in professional continuing education courses or for self-study. This book has a ready audience among graduate students in mechanical and industrial engineering, as well as in many MBA programs focused on manufacturing management. This is a global need that will find a receptive readership in the industrialized world particularly in the rapidly developing industrial economies of South Asia and Southeast Asia. - Reviews the precepts of Product design in a step-by-step structured process and focuses on the concurrent nature of product design - Helps the reader to understand the connection between initial design and interim and final design, including design review and materials selection - Offers insight into roles played by product functionality, ease-of assembly, maintenance and durability, and their interaction with cost estimation and manufacturability through the application of design principles to actual products
Author: Amaresh Chakrabarti
Publisher: Springer Science & Business Media
ISBN: 8132210506
Category : Technology & Engineering
Languages : en
Pages : 1404
Get Book Here
Book Description
This book showcases over 100 cutting-edge research papers from the 4th International Conference on Research into Design (ICoRD’13) – the largest in India in this area – written by eminent researchers from over 20 countries, on the design process, methods and tools, for supporting global product development (GPD). The special features of the book are the variety of insights into the GPD process, and the host of methods and tools at the cutting edge of all major areas of design research for its support. The main benefit of this book for researchers in engineering design and GPD are access to the latest quality research in this area; for practitioners and educators, it is exposure to an empirically validated suite of methods and tools that can be taught and practiced.
Author: Peter N. Golder
Publisher: Edward Elgar Publishing
ISBN: 1784718157
Category : Business & Economics
Languages : en
Pages : 469
Get Book Here
Book Description
New products are the major driver of revenue growth in today's dynamic business environment. In this Handbook, the world's foremost experts on new product development bring together the latest thinking on this vitally important topic. These thought-leading authors organize knowledge into useful and insightful frameworks covering all aspects of new product development: companies, collaborators, customers, context, markets, and performance. Managers will benefit from the handbook by expanding their knowledge of new product development and researchers will learn about opportunities to continue expanding on this body of knowledge.
Author: Ed Schoonveld
Publisher: Routledge
ISBN: 131701930X
Category : Business & Economics
Languages : en
Pages : 494
Get Book Here
Book Description
Public debate on the rising cost of new biotechnology drug treatments has intensified over the last few years as healthcare budget pressures have mounted under a strained economy. Meanwhile, the demand for new, effective medical and drug treatments continues to rise as unhealthy lifestyles cause further increases in diabetes and cardiovascular disease. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences, from healthcare industry professionals to policy makers and the broader public, to gain a better understanding of this highly complex and emotionally charged field. The Price of Global Health is recognized as a valued and unique reference book that covers a complete array of topics related to global pharmaceutical pricing. It contains an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Furthermore, many country chapters have been substantially updated to reflect changes in the healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, medico-economic requirements in France and many other country-specific changes. Lastly, almost every chapter has been updated with new examples and illustrations.
Author: Allen C. Ward
Publisher: Lean Enterprise Institute
ISBN: 1934109444
Category :
Languages : en
Pages : 509
Get Book Here
Book Description
"The P-51 Mustang—perhaps the finest piston engine fighter ever built—was designed and put into flight in just a few months. Specifications were finalized on March 15, 1940; the airfoil prototype was complete on September 9; and the aircraft made its maiden flight on October 26. Now that is a lean development process!" —Allen Ward and Durward Sobek, commenting on the development of the P-51 Mustang and its exemplary use of trade-off curves. Shingo Research and Professional Publication Award recipient, 2008 Despite attempts to interpret and apply lean product development techniques, companies still struggle with design quality problems, long lead times, and high development costs. To be successful, lean product development must go beyond techniques, technologies, conventional concurrent engineering methods, standardized engineering work, and heavyweight project managers. Allen Ward showed the way. In a truly groundbreaking first edition of Lean Product and Process Development, Ward delivered -- with passion and penetrating insights that cannot be found elsewhere -- a comprehensive view of lean principles for developing and sustaining product and process development. In the second edition, Durward Sobek, professor of Mechanical and Industrial Engineering at Montana State University—and one of Ward’s premier students—edits and reorganizes the original text to make it more accessible and actionable. This new edition builds on the first one by: Adding five in-depth and inspiring case studies. Including insightful new examples and illustrations. Updating concepts and tools based on recent developments in product development. Expanding the discussion around the critical concept of set-based concurrent engineering. Adding a more detailed table of contents and an index to make the book more accessible and user-friendly. The True Purpose of Product Development Ward’s core thesis is that the very aim of the product development process is to create profitable operational value streams, and that the key to doing so predictably, efficiently, and effectively is to create useable knowledge. Creating useable knowledge requires learning, so Ward also creates a basic learning model for development. But Ward not only describes the technical tools needed to make lean product and process development actually work. He also delineates the management system, management behaviors, and mental models needed. In this breakthrough text, Ward: Asks fundamental questions about the purpose and “value added” in product development so you gain a crystal clear understanding of essential issues. Shows you how to find the most common forms of “knowledge waste” that plagues product development. Identifies four “cornerstones” of lean product development gleaned from the practices of successful companies like Toyota and its partners, and explains how they differ from conventional practices. Gives you specific, practical recommendations for establishing your own lean development processes. Melds observations of effective teamwork from his military background, engineering fundamentals from his education and personal experience, design methodology from his research, and theories about management and learning from his study of history and experiences with customers. Changes your thinking forever about product development.
