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Author : Pascal Stiefenhofer
Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.:/5 (634 download)
Download or read book Offshoring Outsourcing in the Pharmaceutical Industry written by Pascal Stiefenhofer and published by . This book was released on 2004 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : T. R. Ramanathan
Publisher : Universal-Publishers
ISBN 13 : 1599427095
Total Pages : 187 pages
Book Rating : 4.5/5 (994 download)
Download or read book The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services written by T. R. Ramanathan and published by Universal-Publishers. This book was released on 2009-03 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research study seeks to understand the nature of organisational change with respect to offshore outsourcing of information technology services in a multinational pharmaceutical company, and to examine the effectiveness of approaches used to manage this change so that lessons may be drawn from these experiences. Despite the abundant literature on effective organisational change management, the key factors that need to be managed properly at different stages of the offshore outsourcing process are not well understood. The research adopts a processual view to paint a broad picture of the issues involved in these different stages. A generic process model of change, based on the review of the change literature, was first developed to represent how change was intended to occur. This model focuses on the following four stages in the change process: context, diagnosis and planning, implementation, and institutionalisation. The research employs an interpretive case study approach and draws on fieldwork from three independent information systems departments (cases) of the company, where offshore outsourcing programmes were implemented. Qualitative data from semi-structured interviews, direct observation and document analysis are analysed by applying the generic process model to produce a detailed account of the way in which change was managed in the case organisations. The findings reveal that a combination of contextual factors, both external and internal to the company, influenced the adoption and use of offshore outsourcing in the case organisations. Externally, the economic forces were found to be the main catalyst for the change, while internally the role of the executive leadership and the lack of internal resources further explain the motivations behind the adoption of offshore outsourcing. The study illustrates that achieving successful outcomes from offshore outsourcing activities critically depends on the organisation adequately addressing a number of factors, such as conveying a sense of urgency, developing and communicating the vision, identifying the benefits of change and how they will be delivered, generating short-term wins, providing education and training, developing a fit between the change and organisational culture, etc., throughout the change process. The findings also highlight the effects of offshore outsourcing on the case organisations, including change in job roles and responsibilities and organisational learning activities that enable corrective actions to improve change management efforts. An important contribution of this research is the development of a model providing a more comprehensive understanding of the change process associated with the implementation of offshore IT outsourcing. Recommendations for policy makers and change managers to improve change management practice based on the research findings, as well as recommendations for further research, form a significant part of the conclusions.
Author : William C. Stevens Jr.
Publisher : Lulu.com
ISBN 13 : 0984904905
Total Pages : 277 pages
Book Rating : 4.9/5 (849 download)
Download or read book Pharmaceutical Outsourcing: Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!
Author : Pooja Thakur
Publisher :
ISBN 13 :
Total Pages : 219 pages
Book Rating : 4.:/5 (66 download)
Download or read book Offshoring and Outsourcing of Core Corporate Activities written by Pooja Thakur and published by . This book was released on 2010 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dissertation examines the offshoring and outsourcing of core activities in the pharmaceutical industry. Using primary and secondary data sources, the dissertation adopts a multi-level approach to examine four research questions related to the sourcing strategies of core activities such as clinical trials. Specifically, I look at operational and strategic factors that influence the decision to relocate core activities both organizationally (in-house versus external vendors) and geographically (activities conducted in home nation versus trials in foreign countries). Drawing on Dunning's framework, the dissertation next examines the role of four motives (resource, market, efficiency and strategic asset seeking) in the offshoring decisions while distinguishing between offshore outsourcing and offshoring to foreign affiliates. Using multiple case studies, the third study further investigates the evolution of firms sourcing strategies from conducting core activities in-house to increasingly outsourcing and offshoring them. The final study in the dissertation examines the impact of offshoring and outsourcing on the performance of core activities. Data for this dissertation comes from multiple sources: Primary data from in-depth structured interviews and online survey of vice presidents of clinical affairs of pharmaceutical and biotechnology firms, as well as secondary data from Medidata, Orbis, and World Development Indicators. The dissertation offers evidence that firms tend to use different sourcing strategies for different motives. Specifically, offshoring to foreign affiliates is primarily driven by strategic factors and firms tend to prefer this strategy for strategic asset seeking purposes. Offshore outsourcing on the other hand is motivated by resource and efficiency seeking behavior and the important determinants for this strategy are mainly operational. The third type of sourcing strategy is domestic outsourcing and firms are driven by both strategic as well as operational determinants for this strategy. The qualitative study on strategy evolution points towards a five stage process which begins with in-house sourcing followed by domestic outsourcing, foreign affiliates, offshore outsourcing and finally backsourcing of core activities. Evidence from the dissertation suggests that outsourcing has a positive impact on performance when compared to in-house while offshoring has a negative impact compared to domestic sourcing.
Author : Bianca Piachaud
Publisher : Springer
ISBN 13 : 0230512631
Total Pages : 205 pages
Book Rating : 4.2/5 (35 download)
Download or read book Outsourcing of R&D in the Pharmaceutical Industry written by Bianca Piachaud and published by Springer. This book was released on 2004-09-30 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualisation, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.
Author : Farok J. Contractor
Publisher : Cambridge University Press
ISBN 13 : 1139492233
Total Pages : 493 pages
Book Rating : 4.1/5 (394 download)
Download or read book Global Outsourcing and Offshoring written by Farok J. Contractor and published by Cambridge University Press. This book was released on 2010-11-11 with total page 493 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companies are increasingly asking which of their value chain activities are best performed within their own company and which may be outsourced. In addition, they are also considering which pieces of their value chain may be better performed abroad. These interrelated decisions concerning outsourcing and offshoring have not only changed entire industries, they have also transformed the lives of people across the world. Hundreds of millions of jobs in emerging nations have been the direct result of outsourcing and offshoring decisions. At the same time, many people in the developed world have lost their jobs because a company has been able to find a cheaper alternative. Featuring contributions from scholars in eleven different countries, this book was the first to examine the theory and practice of outsourcing and offshoring simultaneously. It includes studies of a variety of different industries, including pharmaceuticals, automobiles, medical records, appliances, human resource management and telecommunications.
Author : Patrick Taaffe
Publisher :
ISBN 13 : 9781853346132
Total Pages : 116 pages
Book Rating : 4.3/5 (461 download)
Download or read book Outsourcing in the Pharmaceutical Industry written by Patrick Taaffe and published by . This book was released on 1996 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Pharmalicensing
ISBN 13 : 1905310110
Total Pages : 130 pages
Book Rating : 4.9/5 (53 download)
Download or read book Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide written by and published by Pharmalicensing. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : P R Chowdhury
Publisher : Elsevier
ISBN 13 : 1908818018
Total Pages : 133 pages
Book Rating : 4.9/5 (88 download)
Download or read book Outsourcing Biopharma R&D to India written by P R Chowdhury and published by Elsevier. This book was released on 2011-05-05 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon
Author : SOMO Research
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Download or read book Putting Contract Research Organisations on the Radar written by SOMO Research and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is a trend for pharmaceutical companies to contract third parties to conduct their clinical trials in order to test their drugs. This trend is referred to as 'outsourcing', and the companies that carry out the work are called 'contract research organisations' (CROs). In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle-income countries. This trend is called 'offshoring'. It is widely agreed that the offshoring of clinical trials to these regions should be scrutinised from an ethical perspective because of the vulnerability of the trial population. What happens when offshoring is combined with outsourcing? Do additional ethical risks arise when clinical trials are contracted out? Virtually all pharmaceutical companies publicly declare that they test their drugs in accordance with the highest ethical guidelines, such as the Declaration of Helsinki. But how do pharmaceutical companies safeguard their commitments when they outsource clinical trial activities to CROs in poor regions? These are the central questions that are addressed in this report. The report is based on research conducted in India, Argentina, Brazil and Peru, and combined with interviews with pharmaceutical companies and clinical trial experts. The research experiences demonstrate that the pharmaceutical sector is generally not transparent, which hinders the definitive answering of the research questions. Nevertheless, the secondary and interview data collected in India, Argentina, Brazil and Peru provides some valuable insights into the way the CRO sector is developing in these countries. Furthermore, the report demonstrates that pharmaceutical companies have elaborate systems in place to manage their supply chain responsibility, although their functioning can not be independently verified. In addition, experts, authorities and clinical trial practitioners in the selected non-traditional trial regions still expressed grave concerns about the implementation of clinical trials in these countries.
Author : Francois Thomas
Publisher :
ISBN 13 :
Total Pages : 222 pages
Book Rating : 4.:/5 (337 download)
Download or read book Outsourcing Research in the Pharmaceutical Industry written by Francois Thomas and published by . This book was released on 1995 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Magdalena Krekora
Publisher : Kluwer Law International B.V.
ISBN 13 : 9041126422
Total Pages : 462 pages
Book Rating : 4.0/5 (411 download)
Download or read book Contract Manufacturing of Medicines written by Magdalena Krekora and published by Kluwer Law International B.V.. This book was released on 2008-01-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and definition of andmedicineand in different jurisdictions; and categories of medicines; and manufacturing and importation regulation in numerous jurisdictions worldwide; and inspection regimes; and good manufacturing practice (GMP); and marketing authorization; and manufacturing documentation; and complaints and product recall; and liability insurance; and protection of trade secrets; and data exclusivity and data protection; and deficiencies and delays; and and recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.
Author : Cheryl L. Barton
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (83 download)
Download or read book Key Trends in Offshoring Pharmaceutical R&D written by Cheryl L. Barton and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This report discusses the offshore R&D strategies adopted by the industry to improve productivity and efficiency. It covers a variety of strategic partnerships, academic collaborations, and outsourcing opportunities.
Author : Rosemary Gibson
Publisher : Prometheus Books
ISBN 13 : 1633883825
Total Pages : 306 pages
Book Rating : 4.6/5 (338 download)
Download or read book China Rx written by Rosemary Gibson and published by Prometheus Books. This book was released on 2018-04-17 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of Americans are taking prescription drugs made in China and don't know it--and pharmaceutical companies are not eager to tell them. This is a disturbing, well-researched wake-up call for improving the current system of drug supply and manufacturing. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This probing book examines the implications of our reliance on China on the quality and availability of vital medicines.
Author : Mário Franco
Publisher : BoD – Books on Demand
ISBN 13 : 1839684690
Total Pages : 130 pages
Book Rating : 4.8/5 (396 download)
Download or read book Outsourcing and Offshoring written by Mário Franco and published by BoD – Books on Demand. This book was released on 2021-07-07 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: Outsourcing and offshoring are typically viewed as phenomena allowing competitive advantages for organizations, but some studies have not included the risks, benefits, and challenges of these types of strategies. As such, this book fills this gap by combining several studies from different perspectives. The chapters follow several approaches and applications that researchers explore in different contexts. This book adds to the body of knowledge in outsourcing and offshoring areas and shows how these strategies can stimulate organizations’ development in various countries and regions worldwide.
Author :
Publisher :
ISBN 13 :
Total Pages : 114 pages
Book Rating : 4.:/5 (497 download)
Download or read book Outsourcing Resources for the Pharmaceutical Industry written by and published by . This book was released on 2001 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : C. Ralph Buncher
Publisher : CRC Press
ISBN 13 : 142005645X
Total Pages : 497 pages
Book Rating : 4.4/5 (2 download)
Download or read book Statistics In the Pharmaceutical Industry written by C. Ralph Buncher and published by CRC Press. This book was released on 2019-03-07 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.
