The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as 'The Orange Guide', is the essential reference for all manufacturers and distributors of medicines in the UK.It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.The new 11th edition has been updated to incorporate changes made after the UK's exit from the European Union on the 31st January 2020

Technological innovation is fundamental to firm performance and economic prosperity. The aim of this book is to contribute to an in-depth understanding of collective innovation processes by analyzing publicly funded R&D cooperation and innovation networks in the German laser industry. Standing in a neo-Schumpeterian tradition, it employs interdisciplinary analytical concepts and draws upon a unique longitudinal dataset from the laser industry that covers more than two decades of observations. In brief, the book makes a valuable contribution by exploring how and why firm-specific R&D cooperation activities and network positions, large-scale network patterns, and evolutionary network change processes affect the innovative performance of laser source manufacturers in Germany.

Despite its long eclipse by Parisian couture, Italian fashion is now celebrated globally for the quality of its tailoring, fabric and design. But an Italian label was not always a yardstick for excellence. In the twenty years following the Second World War, a little known fact is that America played a key role in the development of Italy's fashion industry. More generally known is that the Marshall Plan had a formative influence on the financial and industrial reorganization of Italian postwar reconstruction. But America's specific influence on the regeneration of the Italian textile industry has been largely passed over, despite the meteoric rise of design houses such as Max Mara, Gucci and Prada.However, while American interest was central to the industrial and stylistic expansion of Italian fashion, the lessons learned were combined with Italian ideas and energies to create fashions with a distinctly Italian edge. This book reveals that a deliberate effort went into the development of an Italian national identity in fashion design, partially in response to American interest. Drawing on a wide range of sources, notably the testimonies of key witnesses, contemporary media reports and surviving garments, this book contributes to the scant research on twentieth century Italian dress and specifically exposes for the first time the depth of American involvement in Italian fashion in a crucial phase of its development.

This book presents a detailed industry-by-industry analysis of output and investment in American manufacturing. With imports soaring and the international indebtedness of the United States increasing, manufacturing has been the sector of the economy most threatened by outside pressures. In a growing number of products, domestic manufacture has ceased to be competitive, and in some products where American technological competence should have brought success, there are no American entries at all. The book's major chapters deal with trends and changes, from 1967 onward, in labor productivity, investment per employee, the location of manufacturing establishments, and the role and impact of imports and exports. In each case, general quantitative analysis is followed by a detailed review of the problems with the products, manufacturing processes, and markets of each industry, thus providing not only an account of the industry's current state, but an agenda for future change and improvement.

This book proposes measures to promote regional industrial development in East Asia from the perspective of three industries: agriculture, food, and tourism. The authors argue that for regional agriculture to develop, collaboration with the food industry is essential. Further, by linking tourism, economic collaboration between the three industries is strengthened. The first part of the book introduces a basic model for the formation of the agriculture, food, and tourism industry cluster. Contributions from leading academics in agricultural economics then go on to discuss the relevance of this multi-industry cluster in countries such as Japan, the Republic of Korea, and Cambodia, amongst others. The final part sets out new approaches for further development in the cluster through quantitative analyses of the 'economies of sequence' concept. Readers will discover that from establishing linkages between different industries and other economic sectors, important positive externalities can be generated and these processes can be triggered on the local or cluster level.

This is one of the first books to draw together information and views about international control of food safety from around the world. Demands for safe food, against a background of increasing trade, are making international controls on food safety essential. Agreements on how to control the safety of food to meet these needs are now in place among the major trading blocks, particularly in Europe and in the USA, and more recently, in Australia. This book also describes progress in areas such as systematically reviewing risk from food; developing national infrastructures to enforce standards; and growing input from consumer groups and others, including economists, to the debate on how to set international food standards. Discussed in depth is the effort to achieve global standards for food safety under the auspices of the Codex Alimentarius Commission. There are chapters from world-leading experts on Codex, international control of radiological contamination, pesticides and veterinary drugs, and other chemical contaminants.

Hurdle Technologies: Combination Treatments for Food Stability, Safety and Quality is the first work on hurdle technology in which all aspects, the possibilities and limitations of hurdle technology, are comprehensively outlined and evaluated. World-renowned on the subject, Leistner and Gould were instrumental in the development of the hurdle technology concept and in the last decades have obtained much practical experience in the application of this successful approach in the food industry worldwide.

Evidence of lean thinking implementation is found in various areas such as services, healthcare, and different industries like the automotive industry, aerospace industry, textile industry, food industry, and oil and gas industry. Such evidence points to the universality of lean thinking and how its use in different contexts increases its importance as an approach to continuous improvement. Lean Thinking in Industry 4.0 and Services for Society presents an insight into lean thinking as a philosophy that can identify problems and wastes in various areas, analyze them, and identify activities that could improve processes. Covering key topics such as industrial systems, lean safety, and lean sustainability, this reference work is ideal for industry professionals, business owners, managers, policymakers, researchers, scholars, academicians, practitioners, instructors, and students.

While there are many quality assurance books on the market, very few address the application of the concept to the seafood industry. In addition, many of the books that are available take a theoretical approach and there fore do not provide actual examples of the "fins and bones" of quality programs. The author, in teaching quality assurance over nine years, has not been able to find a textbook that is suitable as a reference text in quality assurance courses for the seafood industry. It is this situation that has prompted the preparation of this book, which takes a practical approach to the subject of quality assurance in seafood processing operations. This book can serve as either a textbook or as a reference text. As a textbook it is written for students of quality assurance at the technician, technologist, and university levels. In this role it is intended that the student will start at the beginning of the book and proceed through in sequence, so as to gain a complete understanding of the design, implementation, and operation of a quality program in seafood processing operations. It is the hope of the author that the book also functions quite well as a desk reference for the managers of seafood processing operations who need to refer occa sionally to particular items or chapters. In this sense, each chapter is designed to stand alone as a discussion of a particular concept within the quality assurance discipline."

Award-winning journalist and New York Times bestselling author Gerald Posner reveals the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and delivers "a withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients (The New York Times Book Review). Pharmaceutical breakthroughs such as anti-biotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on pre-scription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. "Gerald's dogged reporting, sets Pharma apart from all books on this subject" (The Washington Standard) as we are introduced to brilliant scientists, incorruptible government regulators, and brave whistleblowers facing off against company exec-utives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry's DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America's wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers' rise to power--revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. "Explosively, even addictively, readable" (Booklist, starred review), Pharma reveals how and why American drug com-panies have put earnings ahead of patients.

Price and Markup Behaviour in Manufacturing examines the role that cost, competing domestic and foreign prices, domestic demand and market structure play in determining the price and markup of manufacturing firms across a range of countries and industries. Michael Olive models imperfectly competitive behaviour at the firm level, establishing logical relationships between these variables. Aggregating these relationships gives predictions for price and markup at the industry level. Empirical analysis is carried out by estimating a pricing equation for 11 industrialised countries in Asia, Europe and North America, and for 24 International Standard Industrial Classification industries from 1970 to 1991. The results exhibit a pattern of incomplete pass-through from competing foreign price into industry price and markups that are not fixed. The author illustrates that for higher levels of industry concentration cost becomes less influential in determining industry price, while the opposite is true for competing domestic and foreign prices. This comprehensive and thorough examination of the literature on pricing, the innovative model development and the comparative analysis in this study will be of great interest to government policymakers and academics wanting to keep abreast of new developments in the area of pricing and markup.

At its height British toymaking was a significant industry, with famous names such as Britains and Meccano known throughout the world. While in essence a specialised form of small-scale engineering, its products and market have always been unique, reflecting the current priorities of both parents and children. Yet, while individual toys and marques have been catalogued extensively, no previous history of toymaking as a whole exists. The British Toy Business provides a fascinating example of the development of a specific industry.
Many early early toys were home-made. From the eighteenth century, with its growing recognition of children as something other than small adults, date the beginnings of specialised toys, usually produced by small workshops and sold by street-sellers. The nineteenth century, with its industrial growth and middle-class prosperity, saw an expansion of toymaking.
The 1960s and 1970s were the most successful years of British toymaking, with companies like Lesney making record profits. Yet British toy makers failed to solve a number of fundamental problems. Following an unexpected sudden downturn in sales at a time of high interest rates, the major names in British toy making, Lesney, Airfix, Mettoy and Dunbee Combex Marx, all collapsed between 1979 and 1985, leaving the business to be dominated largely by importers.

Yang analyzes the impact of globalization on national economic boundaries, using the automobile industry to contrast three different economic systems. Corporations emerge as new players in international relations. Their corporate policies and manufacturer-supplier linkages influence the international division of labor among modern nations. Their competitive strategy affects the ability of governments to regulate national economies. Scholars in international, regional, and developmental economics will find this work provides interesting material on global competition.

The promotion of workplace partnership in the high performance workplace has become central to policy debates on the 'modernization' of employment relations in British industry. This book provides critical insights into the dynamics of partnership by way of in-depth case studies of employee experience in an under-researched industry noted for its high concentrations of skilled workers and graduates. Drawing on rich interview and questionnaire data, the authors highlight considerable conflicts of interest in the development of partnership that derive from the competitive capitalist environment in which management strategies operate.

This book introduces the issues and problems that arise when implementing smart energy management for sustainable manufacturing in the automotive manufacturing industry and the analytical tools and applications to deal with them. It uses a number of illustrative examples to explain energy management in automotive manufacturing, which involves most types of manufacturing technology and various levels of energy consumption. It demonstrates how analytical tools can help improve energy management processes, including forecasting, consumption, and performance analysis, emerging new technology identification as well as investment decisions for establishing smart energy consumption practices. It also details practical energy management systems, making it a valuable resource for professionals involved in real energy management processes, and allowing readers to implement the procedures and applications presented.

Examining the dynamics of competence-building processes at the firm level, this book looks at a sample of Japanese and European companies engaged in the field of optoelectronics. The concept was derived from the notion of firm-specific competences which are closely related to the firm's intangible assets and accumulated technological bases. Several factors affect the rate and direction of competence-building, chief among them being primary markets, top management strategy and the evolution of research and development organization, and organizational learning. The book also introduces a technique to assess competences using three types of data on US patenting, scientific publications and qualitative interview data.

This major Handbook offers a comprehensive analysis of the key issues surrounding the rapid expansion of Latin America's manufacturing sector. It systematically examines the most important factors influencing the comparative advantages and the globalization of manufacturing industries in the region. The Handbook of Latin American Trade in Manufactures provides a detailed account of trade and investment policies, international technology transfers, macroeconomic stabilization and structural adjustment policies and industry-specific initiatives affecting the export competitiveness of Latin America's manufactures. The four major parts of the Handbook contain detailed assessments of regional and country-specific developments in manufacturing trade, and the statistical appendix provides essential information on the countries of the region. This Handbook will be welcomed by a wide range of economists in the fields of international trade and investment, industrial organization, development economics and Latin American Trade. It will also be of interest to business analysts and policymakers concerned with the formation of trade strategies.

"This book examines the public controversies surrounding lifestyle risks in the consumer society. Comparing news coverage of the globesity pandemic in Britain and the USA, it illustrates the way moral panic brought childrens food marketing to the centre of the policy debates about consumer lifestyles"--

In British political discourse the idea that in the 1970s trade unions 'ran the country' has become a truism, a folk mythology invoked against the twin perils of socialism and strikes. But who exactly wielded power in Britain's workplaces and on what terms? Assembling cultures takes a fine-grained look at factory activism in the motor industry between 1945 and 1982, using car manufacturing as a key case for unpicking important narratives around affluence, declinism and class. It traces the development of the militant car worker stereotype and looks at the real social relations that lay behind car manufacturing's reputation for conflict. In doing so, this book reveals a changing, complex world of social practices, cultural norms and shared values and expectations. From relatively meagre interwar trade union traditions, during the post-war period car workers developed shop-floor organisations of considerable authority, enabling some to make new demands of their working lives, but constraining others in their more radical political aims. Assembling cultures documents in detail a historic process where, from the 1950s, groups and individuals set about creating and reproducing collective power and asks what that meant for their lives. This is a story of workers and their place in the power relations of post-war Britain. This book will be invaluable to lecturers and students studying the history, sociology and politics of post-war Britain, particularly those with an interest in power, rationality, class, labour, gender and race. The detailed analysis of just how solidarity, organisation and collective action were generated will also prove useful to trade union activists. -- .

Translational Biotechnology: A Journey from Laboratory to Clinics presents an integrative and multidisciplinary approach to biotechnology to help readers bridge the gaps between fundamental and functional research. The book provides state-of-the-art and integrative views of translational biotechnology by covering topics from basic concepts to novel methodologies. Topics discussed include biotechnology-based therapeutics, pathway and target discovery, biological therapeutic modalities, translational bioinformatics, and system and synthetic biology. Additional sections cover drug discovery, precision medicine and the socioeconomic impact of translational biotechnology. This book is valuable for bioinformaticians, biotechnologists, and members of the biomedical field who are interested in learning more about this promising field.

Using the findings from data analysis of fifty-one developing countries, this bookanalyses several national and international factors that have resulted in uneven development of the textiles and clothing industry inthe developing world. The findings are further substantiated by case studies of major players in this industry, such as India and China. While international trade rules have played a critical role in the growth of the textiles and clothing industry, country- and industry-specific policies and capacity building initiatives have also resulted in the present scenarioin several countries. There is no common recipe for all developing countries for sustaining market share in the domestic and international markets.Regional and local factors need to be taken into consideration while formulating policies for the industry.

Competition, Power and Industrial Flexibility assesses the varying ways in which automobile assemblers in several countries of East and Southeast Asia, Europe and the Americas have sought to enhance their efficiency and flexibility in response to heightened global competition during the 1980s and early 1990s. It then explores the implications of such managerial strategies for workers and trade unions, and the responses of unions in seeking to preserve or enhance worker welfare and voice under industrial restructuring.

This is the third book in what the author calls his sin trilogy: the gambling, tobacco, and alcohol industries. Similar to the gambling and tobacco industries, the alcohol industry is one in which the business and public policy processes are intimately linked. Furthermore, it is a highly regulated industry whose very existence depends upon the will of government at all levels and branches. What all the industries share is that they are viewed as a painless source of revenue for government. The alcohol industry is composed of three segments, namely beer, distilled spirits, and wine, each with a distinct product and market. Since the end of Prohibition, public policy makers have developed a certain tolerance for alcohol products, but they continue to grapple with the question of how to deal with the alcohol problem. While the author updates the current structure and strategies of competition among these industries, his primary rationale for doing so is to analyze how these industries react to increased public scrutiny of their business activities. The other unique feature of this book is its emphasis on how public policy measures affect the sale of beer, distilled spirits, and wine at the state level.