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| technology transfer in pharmaceutical industry: ISPE Good Practice Guide Ispe, 2019-01-24 |
| technology transfer in pharmaceutical industry: Technology Transfer , 1988 |
| technology transfer in pharmaceutical industry: Technology Transfer Systems in the United States and Germany Fraunhofer Institute for Systems and Innovation Research, National Academy of Engineering, 1997-10-10 This book explores major similarities and differences in the structure, conduct, and performance of the national technology transfer systems of Germany and the United States. It maps the technology transfer landscape in each country in detail, uses case studies to examine the dynamics of technology transfer in four major technology areas, and identifies areas and opportunities for further mutual learning between the two national systems. |
| technology transfer in pharmaceutical industry: Pharmaceutical Preformulation and Formulation Mark Gibson, 2016-04-19 Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne |
| technology transfer in pharmaceutical industry: Enabling America Institute of Medicine, Committee on Assessing Rehabilitation Science and Engineering, 1997-11-24 The most recent high-profile advocate for Americans with disabilities, actor Christopher Reeve, has highlighted for the public the economic and social costs of disability and the importance of rehabilitation. Enabling America is a major analysis of the field of rehabilitation science and engineering. The book explains how to achieve recognition for this evolving field of study, how to set priorities, and how to improve the organization and administration of the numerous federal research programs in this area. The committee introduces the enabling-disability process model, which enhances the concepts of disability and rehabilitation, and reviews what is known and what research priorities are emerging in the areas of: Pathology and impairment, including differences between children and adults. Functional limitationsâ€in a person's ability to eat or walk, for example. Disability as the interaction between a person's pathologies, impairments, and functional limitations and the surrounding physical and social environments. This landmark volume will be of special interest to anyone involved in rehabilitation science and engineering: federal policymakers, rehabilitation practitioners and administrators, researchers, and advocates for persons with disabilities. |
| technology transfer in pharmaceutical industry: Continuous Manufacturing for the Modernization of Pharmaceutical Production National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, 2019-04-05 On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop. |
| technology transfer in pharmaceutical industry: Transfer of Technology for Successful Integration Into the Global Economy United Nations, UNCTAD/UNDP Programme on Globalization, Liberalization and Sustainable Human Development, 2003 This publication contains three case studies which seek to disseminate information on best practices for promoting transfer of technology in developing countries, in order to help establish new industries which can successfully compete in the global economy. These studies were carried out under the UNCTAD/UNDP Programme on Globalization, Liberalization and Sustainable Human Development, and deal with aircraft manufacturing in Brazil, the pharmaceuticals sector in India and the automobile industry in South Africa. |
| technology transfer in pharmaceutical industry: Biotechnology Entrepreneurship Craig Shimasaki, 2014-04-08 As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts |
| technology transfer in pharmaceutical industry: The Changing Economics of Medical Technology Institute of Medicine, Committee on Technological Innovation in Medicine, 1991-02-01 Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€as well as the involvement of numerous government agenciesâ€affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public. |
| technology transfer in pharmaceutical industry: Technology Transfer Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram, 2023-06-16 Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry. |
| technology transfer in pharmaceutical industry: Chemical Engineering in the Pharmaceutical Industry Mary T. am Ende, David J. am Ende, 2019-04-08 A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products. |
| technology transfer in pharmaceutical industry: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| technology transfer in pharmaceutical industry: Expansion Joints in Buildings National Research Council, Division on Engineering and Physical Sciences, Federal Facilities Council, Building Research Advisory Board, Standing Committee on Structural Engineering of the Federal Construction Council, 1974-02-01 Many factors affect the amount of temperature-induced movement that occurs in a building and the extent to which this movement can occur before serious damage develops or extensive maintenance is required. In some cases joints are being omitted where they are needed, creating a risk of structural failures or causing unnecessary operations and maintenance costs. In other cases, expansion joints are being used where they are not required, increasing the initial cost of construction and creating space utilization problems. As of 1974, there were no nationally acceptable procedures for precise determination of the size and the location of expansion joints in buildings. Most designers and federal construction agencies individually adopted and developed guidelines based on experience and rough calculations leading to significant differences in the various guidelines used for locating and sizing expansion joints. In response to this complex problem, Expansion Joints in Buildings: Technical Report No. 65 provides federal agencies with practical procedures for evaluating the need for through-building expansion joints in structural framing systems. The report offers guidelines and criteria to standardize the practice of expansion joints in buildings and decrease problems associated with the misuse of expansions joints. Expansions Joints in Buildings: Technical Report No. 65 also makes notable recommendations concerning expansion, isolation, joints, and the manner in which they permit separate segments of the structural frame to expand and to contract in response to temperature fluctuations without adversely affecting the buildings structural integrity or serviceability. |
| technology transfer in pharmaceutical industry: Technology Transfer in International Business Tamir Agmon, Mary Ann Young Von Glinow, 1991 This is a book on the means by which technological knowledge is transferred from countries that develop it to those that need it, but have not yet been able to develop it on their own. The focus is on the transfer of technology from Western countries to Asian countries. |
| technology transfer in pharmaceutical industry: Containment Technology Hans-Jürgen Bässler, Frank Lehmann, 2013-10-01 This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology. |
| technology transfer in pharmaceutical industry: International Experience in Developing the Financial Resources of Universities Abdulrahman Obaid AI-Youbi, Adnan Hamza Mohammad Zahed, Abdullah Atalar, 2021-10-04 This open access book aims to present the experiences and visions of several world university leaders, providing strategies and methods used to find various income sources for their institutions. The expansion of a university system requires a corresponding increase in funding. Consequently, university administrators all over the world are in a constant search for additional funds. If higher-level institutions are expected to deliver high-quality education and research, their sustainable funding is crucial to the development of the countries they serve. While governmental sources are a major part of the funding of most universities, economic downturns as in the case of the COVID-19 crisis may reduce governmental contributions in this and cause administrators to look for various alternative sources to help them compete in a global setting. This book offers valuable information and guidance to university leaders and administrators worldwide especially at a time when university budgets are under stress due to the COVID-19 pandemic with its dire financial and economic consequences. |
| technology transfer in pharmaceutical industry: Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach Valentina Emilia Balas, Vijender Kumar Solanki, Raghvendra Kumar, 2019-09-24 Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches, create efficiencies and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Pharmaceutical manufacturing companies are no exception to this, as IoT has the potential to revolutionize aspects of the pharmaceutical manufacturing process, from drug discovery to manufacturing. Using clear, concise language and real world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety of topics presented offers readers multiple perspectives on a how to integrate the Internet of Things into pharmaceutical manufacturing. - Covers efficiency improvements of pharmaceutical manufacturing through IoT/Big Data approaches - Explores cutting-edge technologies through sensor enabled environment in the pharmaceutical industry - Discusses the systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing |
| technology transfer in pharmaceutical industry: Pharmaceutical Quality Systems Oliver Schmidt, 2000-04-30 When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr |
| technology transfer in pharmaceutical industry: Pharmaceutical Process Development John Blacker, Michael T Williams, 2011-08-17 Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery. |
| technology transfer in pharmaceutical industry: Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, 2015-04-01 This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs. |
| technology transfer in pharmaceutical industry: Global Dimensions of Intellectual Property Rights in Science and Technology National Research Council, Policy and Global Affairs, Office of International Affairs, 1993-02-01 As technological developments multiply around the globeâ€even as the patenting of human genes comes under serious discussionâ€nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences. |
| technology transfer in pharmaceutical industry: Technology Transfer Mark Gibson, 2005 |
| technology transfer in pharmaceutical industry: Genes and Ingenuity Australia. Law Reform Commission, Australian Law Reform Commission, 2004 Report of an inquiry concerned with two broad issues: the patenting of genetic materials and technologies, and the exploitation of these patents and the distinction that can and possibly should be made between discoveries and inventions when referring to claims over genetic sequences. |
| technology transfer in pharmaceutical industry: Sources of Medical Technology Committee on Technological Innovation in Medicine, Institute of Medicine, 1995-01-15 Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology. |
| technology transfer in pharmaceutical industry: Pharmaceutical R&D , 1993 Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms. |
| technology transfer in pharmaceutical industry: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| technology transfer in pharmaceutical industry: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-03-11 This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. |
| technology transfer in pharmaceutical industry: Research and Development in the Pharmaceutical Industry (A CBO Study) Congressional Budget Office, 2013-06-09 Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation... |
| technology transfer in pharmaceutical industry: The Business of Healthcare Innovation Lawton Robert Burns, 2005-08-25 The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants. |
| technology transfer in pharmaceutical industry: Orphans and Incentives Institute of Medicine, Forum on Emerging Infections, 1997-10-30 Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues. |
| technology transfer in pharmaceutical industry: Vaccines, Medicines and COVID-19 Germán Velásquez, 2022-01-01 This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19. |
| technology transfer in pharmaceutical industry: Guideline on General Principles of Process Validation , 1987 |
| technology transfer in pharmaceutical industry: Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine, Board on Health Sciences Policy, Committee on Conflict of Interest in Medical Research, Education, and Practice, 2009-09-16 Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine. |
| technology transfer in pharmaceutical industry: Countering the Problem of Falsified and Substandard Drugs Institute of Medicine, Board on Global Health, Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, 2013-06-20 The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines. |
| technology transfer in pharmaceutical industry: Pharmaceuticals, Corporate Crime and Public Health Graham Dukes, John Braithwaite, J P Moloney, 2014-06-27 The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr |
| technology transfer in pharmaceutical industry: Chemical Engineering in the Pharmaceutical Industry David J. am Ende, Mary T. am Ende, 2019-04-23 A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products. |
| technology transfer in pharmaceutical industry: Intellectual Property and Sustainable Development Ricardo Meléndez-Ortiz, Pedro Roffe, 2009 ÔThis is a thought-provoking book with relevance to a broad readership, especially IP practitioners with a strong international focus.Õ Ð Australian Intellectual Property Law Bulletin Intellectual property (IP) has gained an unprecedented importance in the new world of globalization and the knowledge economy. However, experience, as well as cyclical attitudes toward IP, show that there is no universal model of IP protection. This comprehensive book considers new and emerging IP issues from a development perspective, examining recent trends and developments in this area. Presenting an overview of the IP landscape in general, the contributing authors subsequently narrow their focus, providing wide-ranging case studies from countries across Africa, Asia and Latin America on topical issues in the current IP discourse. These include the impact of IP on the pharmaceutical sector, the protection of life forms and traditional knowledge, geographical indications, access to knowledge and public research institutes, and the role of competition policy. The challenges developing countries face in the TRIPS-Plus world are also explored in detail. The diverse range of contributions to this thought-provoking book offer a wide variety of alternative perspectives on and solutions for the controversial issues surrounding the role of IP within sustainable development. As such, it will prove a stimulating read for government policy-makers, trade negotiators, academics, lawyers and IP practitioners in general, UN and other intergovernmental agencies, development campaigners and aid agencies, environmentalist groups and university students. |
| technology transfer in pharmaceutical industry: Technology Transfer Stewart Green, Paul Warren, 2002-08-14 This text is written by two leading quality specialists and serves as a quick guide reviewing the basic concepts associated with the transfer of product development between manufacturing sites, often to different parts of the world where cultural and management differences abound. It is a hot topic which is brought down to earth, covering key activities, documentation, reporting, and post-transfer reporting for manufacturing professionals. |
| technology transfer in pharmaceutical industry: FTO (freedom to Operate) in the Pharmaceutical Industry Hirotaka Nonaka, 2018 Key features of innovation in the pharmaceutical industry -- How to achieve freedom to operate (FTO) -- Dealing with adverse patents -- Structure and operation of FTO-licensing markets in the parmaceutical industry -- FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company. |
| technology transfer in pharmaceutical industry: Sociétés Transnationales United Nations Conference on Trade and Development. Programme on Transnational Corporations, 1993 |
WHO guidelines on technology transfer in pharmaceutical …
43 SCHEDULE FOR DRAFT WORKING DOCUMENT QAS/20.869: 44 WHO guidelines on technology transfer. 46 45 in pharmaceutical manufacturingDescription of ActivityDateFollowing a recommendation by the WHO Local Production & October 2020 Assistance Unit, the Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) recommended ...
WHO guidelines on technology transfer in pharmaceutical …
1.1 Technology transfer is a logical procedure involving the transfer of products, processes and knowledge, supported by relevant documentation and professional expertise. Technology transfer may include development, manufacturing and testing sites. 1.2 The transfer of production and control procedures of pharmaceutical
Annex 7 WHO guidelines on transfer of technology in pharmaceutical ...
sending unit (SU) The involved disciplines at an organization from where a designated product, process or method is expected to be transferred. spiking. The addition of a known amount of a compound to a standard, sample or placebo, typically for the purpose of confi rming the performance of an analytical procedure.
TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRY …
11 Mar 2012 · In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the ...
TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY: PROCESS TRANSFER …
1 Jan 2021 · The article attempts to discuss the issues associated with technology transfer in the pharmaceutical industry. A major decision focuses on that point where the idea or process is advanced from a ...
Tech Transfers in Pharma: Definitions and Key Processes in Technology …
In the pharmaceutical industry a technology transfer -more commonly known as a tech transfer – is a series of knowledge transfers on a drug product and its established manufacturing processes from development to commercial production. The ICH Q10 guidance explains the purpose of technology transfer as follows:
Technology Transfer in the Pharmaceutical Industry Explained
The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing.
TRS 1044 - Annex 4: WHO guidelines on technology transfer in ...
30 Apr 2022 · Overview . During the fifty-fifth meeting of the World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations, Expert Committee members were updated on the annual consultation on good practices for health products manufacture and inspection, which took place in July 2020 over a series of virtual meetings due to the COVID …
Technology Transfer and Pharmaceutical Quality Systems
Pharmaceutical Quality Systems “A Common Thread to Tech Transfer”. ICH Q10 “The change management system should provide management and documentation of adjustments made to the process during technology transfer activities.”. “Aspects of management review should be performed to ensure the developed product and process can be ...
Technology Transfer in the Pharmaceutical Industry
A process or analytical method technology transfer (TT) can take place at any stage of the life cycle of most products: from preclinical development through clinical studies, scale-up and launch to the post-approval phase. The reason to start a TT can be driven by project needs but also due to strategic management decisions.
Annex 7 WHO guidelines on transfer of technology in pharmaceutical ...
Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies. 1.3 Literature searches revealed l ittle information on the sub ject or iginating
Review Article A Review on Technology Transfer: A Significant …
A Review on Technology Transfer: A Significant Facet in Pharmaceutical Industry Authors: Bhagyesh U. Janugade1,2*, 2Neelam Singla1, Rohit R. Bhosale ... In pharmaceutical industry, TT is the process that includes necessary processes for the successful transition from drug discovery to product development, clinical trials, and ultimately, full ...
AN OVERVIEW OF TECHNOLOGY TRANSFER AS A REGULATORY …
Across the pharmaceutical industry technology transfer states that the processes related to the fortunate movement of drug discovery to development and finally full-size promotion [2].
TECHNOLOGY TRANSFER DOSAGE FORMS GUIDELINE - IPA India
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization. ICH Q10 “The goal of technology transfer activities is to transfer product and process knowledge between
Review on Technology Transfer in Pharmaceutical Manufacturing
technology transfer in the pharmaceutical business in depth. The goal, reasons for experiencing technology transfer, factors that affect technology ... "Technology Transfer" in the pharmaceutical industry refers to a way of taking successful steps forward from medication discovery through product development, clinical trials, and finally ...
Using TRIZ to Accelerate Technology Transfer in the Pharmaceutical Industry
several areas of the pharmaceutical industry. Keywords: TRIZ, TRIZcase study, pharmaceutical industry, technology transfer 1. Introduction In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials
ICH Q10 - Pharmaceutical Quality System
Pharmaceutical industry is still way behind other industries in Quality Management philosophies/practices ... Technology Transfer Investigational Products Management Responsibilities Process Performance & Product Quality …
Technology Transfer : Issues, Challenges and Road Map - APCTT
IMPORTANCE OF TECHNOLOGY TRANSFER & COMMERCIALIZATION Technology is key to economic growth and international competition Results in manufacturing of R&D output Facilitates employment generation Enables wealth creation Helps in enhancing the National competitiveness Technology transfer becomes vital, when time-to- market is key to success
From Bench to Market: Vaccines Technology Transfer
pharmaceutical industry to produce and mobilize an unprecedented number of doses. Success relied on global manufacturing capacity and rapid and efficient technology transfer, which disseminated the knowledge and ability to produce these vaccines.1 This whitepaper provides an overview of the technology transfer process and describes
ICH Q7 Chapter 12 & 19.6: Process Validation
3 ICH Q7 Training Chapter 12 & 19.6: Process Validation Content • General about Validation • Validation Policy (12.1) • Validation Documentation (12.2) • Qualification (12.3) • Process Validation (12.4) • Process Validation Program (12.5) • Periodic Review of Validated Systems (12.6) • Validation of APIs Used In Clinical Trials (19.6)
Overview of NIH Technology Transfer:
pharmaceutical industry, because manufacturers were unwilling to undertake the expense without some ... NIH Technology Transfer; NIH Tech Transfer; Clinical Trial Agreements; CRADA; Intellectual Property; NIH Patent and License Policy; Technology Transfer Cycle; Created Date:
TECHNOLOGY TRANSFER:
3. Technology Transfer: Organisation Strategy and Planning 25 Steve Burns and Mark Gibson Introduction 25 Stages of the Technology Transfer Process 26 Stage 1: Pre-technology Transfer Preparation 26 Technology Transfer Strategies 29 Stage 2: Scale-up and Establish Process at Commercial Scale 32 Stage 3: Plan and Perform Process Validation 33 Management of …
Annex 7 WHO guidelines on transfer of technology in pharmaceutical ...
Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies. 1.3 Literature searches revealed l ittle information on the sub ject or iginating
Challenges of Analytical Method Transfer in the Pharmaceutical Industry
RSSL White Paper Challenges of Analytical Method Transfer in the Pharmaceutical Industry Page 5 Method Transfer Strategies When undertaking analytical method transfer, it is important to base the approach on the stage of development. As would be expected, the later the stage in the development life-cycle, the more stringent the requirements.
Transfer Pricing and Pharmaceutical industry - TPA Global
Transfer Pricing and Pharmaceutical industry. 2 Taking control of the future tpa-global.com Agenda 1. Operating models in the pharmaceutical industry 2. Offshoring versus reshoring impact on global value chains 3. Why certain structures do not work anymore 4. Practical tips for FY2020 documentation given Covid-19 impact on the pharmaceutical ...
Our position on Technology Transfer and Capacity Building - GSK
• There are many factors that enable the pharmaceutical industry to invest in a country or partner with community members. These include appropriate economic, scientific and market conditions; ... high cost of goods industry. Successful technology transfer of vaccines goes far beyond the sharing of patent information, requiring a foundation ...
Quality Risk Management (QRM) in Pharmaceutical Industry: …
manufacturing techniques used in pharmaceutical industry lag far behind that used in a detergent industry or potato-chip industry. One cannot agree that quality of medicines can be similar to that of detergents. The US Food and Drug Administration (FDA) put this problem in a 2004 report as “Pharmaceutical manufacturing operations are inefficient
A Comprehensive Review On Technology Transfer Of …
party."Technology transfer" is the term used to describe the process in the pharmaceutical industry of going from drug discovery to development, clinical trials, and ultimately full-scale commercialization.The conclusion of improving a quality drug item's definition greatly depends on adaptability and successful innovation. ...
ICH HARMONISED TRIPARTITE GUIDELINE
effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term ... technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; ...
DOI: Technology Transfer: An Overview of Process Transfer From ...
isting merchandise or transfer of technology between the two producing units. Process of technology transfer Figure 1: Flow Chart of Technology Transfer in the Pharma-ceutical Industry. ABSTRACT. Objective: The journey of a brand-new compound from a quest laboratory followed by pilot plant production then proportion
Technology Transfer: Case Studies from the Real World
Technology Transfer: Case Studies from the . Real World. PDA I. srael Technology Transfer and Working with CMO/CDMO. Tel Aviv, 4th March 2019. Ofer Dubinsky, Ph.D. Bio-Technology General (Israel) Ltd. 2 Types of Tech Transfer: ... were done in Pharmaceutical & Analytical Development department at BTG
National strategy and plan of action for pharmaceutical …
26 Jun 2015 · countries through technology transfer and local production, as well as through a ... local pharmaceutical industry during the past five years, with an observable positive impact. GTP-I has played an important role, including laying the groundwork for the
A Review on Technology Development and Transfer
technology transfer, reasons for using technology Transfer, the importance of technology transfer and also the issues involved in the technology transfer within the pharmaceutical industry. KEYWORDS: Technology transfer, Scale-up, Exhibit, Pharmaceutical production. I. INTRODUCTION: Technology transfer is the process of
Technology Transfer, A Risk Management Approach
of technology transfer in the pharmaceutical industry, more specifically in Laboratório Edol, through the description of transfer planning and associated documentation (contract, proposal, implementation plan and package), of the main project phases (process development, facility fit assessment, team selection,
Pilot-Scale Studies, Scaling-Up, and Technology Transfer - Springer
Technology transfer activities guide the transfer of product and process knowledge from development to manufac - turing or between manufacturers. 3.1 Framework for Technology Transfer. Laying the groundwork is key in technology transfer. Ensuring that those who are working on the transfer have the required experience and skills will help ensure ...
The Effective Management of Change Across the ICHQ10 …
The context :ICHQ10 ICH Q10 Pharmaceutical Quality System Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation
EPO TECHNOLOGY TRANSFER CASE STUDIES | DERMIS PHARMA …
technology transfer in the pharmaceutical industry. It regularly takes more than 30 months until a sustainable commercialisation deal is closed. TAKEAWAY At the time, Turkey was still practising what is called the professor’s privilege, meaning that the academics were expected to file their own patent applications. 1 However, not
Digital Tech Transfer in the Pharmaceutical Industry
about tech transfer and manufacturing; challenging them to operate very differently. Due to the smaller patient populations, long expensive development and tech transfer cycles will be prohibitive to conduct. Trends Impacting the Pharmaceutical Industry A major focus in the pharmaceutical industry is time to patient.
Pharmaceutical Production and Related Technology Transfer
19 Feb 2019 · Pharmaceutical Production and Related Technology Transfer Pharmaceutical Production and Related Technology Transfer Intellectual Property and Trade Financing Technology Transfer Improving Access R&D, Innovation Monitoring and Reporting ISBN 978 92 4 150235 1 1109_0373_COUV_1_4.indd 1 10/10/11 09:36.
Blockchain technology in the pharmaceutical industry: a
blockchain technology in the pharmaceutical industry, including in applications such as tracking and tracing, counterfeit prevention, distribution, and data security. The review
CHEMICAL ENGINEERING IN THE PHARMACEUTICAL INDUSTRY …
1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3 David J. am Ende and Mary T. am Ende 2 Current Challenges and Opportunities in the Pharmaceutical Industry 19 Joseph L. Kukura and Michael P. Thien PART II MASS AND ENERGY BALANCES 27 3 Process Safety and Reaction Hazard Assessment 29 Wim Dermaut
Technology transfer in the interwar U.S. pharmaceutical sector: …
The indigenous American pharmaceutical industry was dominated by ‘patent-medicine’ producers, specialist producers of vigorously promoted herbal elixirs and tinctures of ... depending on a largely concealed transfer of technology and know-how during the 1930s from its former German parent, E. Merck of
Guidelines for a pharmaceutical technology transfer towards a …
In the area of pharmaceutical industry, investments in innova-tion show a well-known increase as a consequence of a suit-able financial situation that becomes apparent in an important ... A pharmaceutical technology transfer can be defined as the transfer of scientific information, a capability or a technologi- ...
Technical Report No. 65
transfer activities in the pharmaceutical industry. 1.2 Scope. The report provides an overview of the knowledge and skills used during a successful technology . transfer project (TTP) along with references to consult, if necessary. The report includes practical …
THE PROCESS OF TECHNOLOGY TRANSFER TO THE NEW …
the process of technology transfer to biomedical and pharmaceutical start-ups. It is based on detailed data gathered from 26 firms, founded between 1968 and 1975 in the Commonwealth of Massachusetts. The routes of technology transfer were traced, and the comparative impact of entrepreneurial professional experience,
Format and Contents of a Technology Transfer Package
Title: Format and Contents of a Technology Transfer Package . SOP Number: 25103 Revision Number: 03 Supersedes: Revision 02 Effective Date: JUN 04 2020 . Originator/Date: Approval/Date: Approval/Date: Table of Contents . 1.0 Purpose 2.0 Scope . 3.0 Authority and Responsibility 4.0 Format 5.0 Organization 6.0 References and Related Documents
Licensing and Technology Transfer in the Pharmaceutical Industry 1
1.2 How does technology transfer take place? Technology transfer in this way takes place by creating legal relationships by which: 1. th e owner of technology, or 2. the holder of licensed rights to exploit the technology grants new rights of exploitation to the technology transfer partner. These legal relationships are contractual in nature.
Scale Up and Technology Transfer of Pharmaceutical Suspensions
control of oral suspensions have presented dilemmas to the industry. There are issues which have led to recalls (FDA Document 2006). These include microbio- ... 8 Scale Up and Technology Transfer of Pharmaceutical Suspensions 249 BookID 138940_ChapID 8_Proof# 1 - 05/10/2009 critical for extended release suspensions. Particle size would be a ...
Localization of Pharmaceutical Manufacturing in Middle East and …
change in the global pharmaceutical industry’s operations. As with any other sector, the pharmaceutical industry has been impacted by the pandemic and is undergoing a paradigm shift in the post-COVID-19 recovery path. These challenging times have brought to the fore the extreme reliance of the Middle East and North Africa (MENA) countries
Technology Transfer
9:00 Technology Transfer – Definition and Main Principles • Opportunities along product lifecycle • Regulatory guidance on technology transfer • Planning and Social Intelligence • Tool for planning 10:00 Technology Transfer – Definition and Main Principles (continued) • Tool for Social Intelligence • Role and responsibility
Technology Transfer Strategies: Maximizing the returns from new ...
Technology Transfer Strategies Maximizing the returns from new technologies Key Findings ... A common industry complaint about interactions with technology transfer offices is ‘a lack of ... pharmaceutical industry executives. Technology Transfer Strategies
Guidelines for Preparing a Technology Transfer Agreement - APCTT
Commercialization of Patents in the Shoes of Investors • Commercial ventures based on new patents could be capital-intensive and investments have long payback period. • Investors look for clear ownership of Intellectual Property (IP) • Investors are well aware of the centrality of patents in the industry and will conduct a thorough due diligence prior to taking a decision to invest.
Technology Transfer Challenges and Opportunities in the Region
From a Latin American standpoint, Technology Transfer in the pharmaceutical industry does not reflect widespread use, mainly due to the lack of sufficiently developed ecosystems for the transfer process to take place. The willingness of a country to mass-produce certain medicines,
Blueprint for innovation: Advancing biopharma through technology transfer
Technology transfers (tech transfers) are at the heart of pharmaceutical manufacturing organizations. They’re a pivotal component in bringing pharmaceutical products from research and development to initial commercialization and, eventually, to full-scale production. Tech transfers can also be important when outsourcing
Technology Transfer In Pharmaceutical Industry [PDF]
Technology Transfer In Pharmaceutical Industry books and manuals for download, along with some popular platforms that offer these resources. One of the significant advantages of Technology Transfer In Pharmaceutical Industry books and
The key aspects during departmental technology transfer - DiVA …
technology transfer Hilding Sandström Parke and William Sonesson In this case study the authors have tried to fill the gap of technology transfer literature focused on the biopharmaceutical industry. The technology transfer literature displays a clear industry-specific gap, mostly focused on heavy- and pharmaceutical industries.
THE IMPORTANT ROLE OF TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY …
In pharmaceutical industry Technology Transfer refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately full scale commercialization a Technology Transfer is a logical procedure that controls the transfer of any process together with its documentation and professional expertise ...
Studies in Technology Transfer - UNCTAD
experiences of the role of technology transfer and absorption in the development of four different industries in economies from Africa (South Africa), Asia (Taiwan Province of China and China) and Latin America (Argentina). The issue of technology transfer is …
The Pharmaceutical Quality System (PQS) - U.S. Food and Drug …
Quality Production Laboratory Materials Facilities and Equipment Packaging and Labeling Regulatory Education for Industry (REdI):
TECHNOLOGY TRANSFER IN PRACTICE Stewart Green - idu.ac.id
TECHNOLOGY TRANSFER VALIDATION IN PRACTICE Contents Preface Acknowledgements 1 Purpose 2 Scope 3 The Technology Transfer Team 4 Technology Transfer: Key Activities 4.1 Timelines 4.2 Regulatory Issues 4.3 Determining the Process Scope 4.3.1 Managing Change 4.4 Documentation 4.5 Validation 4.5.1 Process Validation 4.5.2 Cleaning Validation
