Download or read book Legal and Ethical Regulation of Biomedical Research in Developing Countries written by Remigius N. Nwabueze and published by Routledge. This book was released on 2016-04-22 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has been a rapid increase in the pace and scope of international collaborative research in developing countries in recent years. This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as the role of ethics committees. Providing a detailed analysis of the law of negligence and its application to research ethics committees and their members, common law and constitutional forms of action and potential negligence claims, the book concludes by suggesting new protocols and frameworks, improved regulation and litigation. This book will be a valuable guide for students, researchers, and policy-makers with an interest in medical law and ethics, bioethics, customary law in Africa and regulation in developing countries.

Download or read book CRO Contract Research Organization How Drug Research is Evolving written by Jakob Miera and published by Anchor Academic Publishing (aap_verlag). This book was released on 2014-02-01 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals in general with mergers & acquisitions in the CRO industry, and more specifically with reasons for M&A, success factors during the M&A process, and why M&A can fail in the Contract Research Organization industry. The pharmaceutical industry faces increasing obstacles in respect to the development and introduction of new medications. That has to do with stricter requirements for admission and sharper controls by authorities. Today, the research and development of a new drug can easily consume more than $800 million and lasting between 10 and 15 years. Due to these facts pharmaceutical companies are looking for an alternative in the drug development process. A popular alternative is the outsourcing or in-house working with Contract Research Organizations (CRO). CRO are specialized in coordination and monitoring of drug development activities. The size of the CRO market in 2012 was around $32 billion and had an estimated market growth of around 9 – 12% for 2013. Increased outsourcing and allocation of R&D money towards CRO reflects a driving force for prospective growth. Contract Research Organizations consider mergers & acquisitions as a vital solution to achieve their objectives.

Download or read book Clinical Research Monitoring A European Approach written by A A Van Dooren and published by World Scientific. This book was released on 2017-09-21 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged.This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research.Related Link(s)

Download or read book The Politics of the Pharmaceutical Industry and Access to Medicines written by Hans Löfgren and published by Routledge. This book was released on 2017-07-06 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals. Please note: Taylor & Francis does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka

Download or read book Controversies in Latin American Bioethics written by Eduardo Rivera-López and published by Springer. This book was released on 2019-06-19 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a first rate selection of academic articles on Latin American bioethics. It covers different issues, such as vulnerability, abortion, biomedical research with human subjects, environment, exploitation, commodification, reproductive medicine, among others. Latin American bioethics has been, to an important extent, parochial and unable to meet stringent international standards of rational philosophical discussion. The new generations of bioethicists are changing this situation, and this book demonstrates that change. All articles are written from the perspective of Latin American scholars from several disciplines such as philosophy and law. Working with the tools of analytical philosophy and jurisprudence, this book defends views with rational argument, and opening for pluralistic discussion.

Download or read book Equity and Access written by Purendra Prasad and published by Oxford University Press. This book was released on 2018-04-17 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equity and Access attempts to unravel the complex narrative of why inequities in the health sector are growing and access to basic health care is worsening, and the underlying forces that contribute to this situation. It draws attention to the way globalization has influenced India’s development trajectory as healthcare issues have assumed significant socio-economic and political significance in contemporary India. The volume explains how state and market forces have progressively heightened the iniquitous health care system and the process through which substantial burden of meeting health care needs has fallen on the individual households. Twenty-eight scholars comprising social scientists, medical experts, public health experts, policy makers, health activists, legal experts, and gender specialists have delved into the politics of access for different classes, castes, gender, and other categories to contribute to a new field ‘health care studies’ in this volume. Adopting an interdisciplinary approach within a broader political-economy framework, the volume is useful for understanding power relations within social groups and complex organizational systems.

Download or read book Multinational Enterprises and Sustainable Development written by Pervez N. Ghauri and published by Emerald Group Publishing. This book was released on 2017-09-25 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reports the results of the large international 'MNEmerge' research project, financed by the European Commission, and provides an understanding of the impact of multinational enterprises on United Nations Millennium Development Goals and successive Sustainable Development Goals in developing countries.

Download or read book Clinical Trials in Latin America Where Ethics and Business Clash written by Nuria Homedes and published by Springer Science & Business Media. This book was released on 2013-11-29 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​

Download or read book Health Research Governance in Africa written by Cheluchi Onyemelukwe-Onuobia and published by Routledge. This book was released on 2018-09-06 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: The globalisation of research has resulted in the increased location of research involving humans in developing countries. Countries in Africa, along with China and India, have seen research grow significantly. With emerging infectious diseases, such as Ebola and Zika, emphasising the risk of public health crises throughout the world, a further increase in health research, including clinical research in developing countries, which are often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and the governance of health research. This book presents a comprehensive and systemic view of the regulation of research involving humans in African countries. It employs case studies from four countries in which research activities continue to rise, and which have taken steps to regulate health research activity: South Africa, Nigeria, Kenya, and Egypt. The book examines the historical and political contexts of these governance efforts. It describes the research context, some of the research taking place, and the current challenges. It also looks at the governance mechanisms, ranging from domestic ethical guidelines to legal frameworks, the strengthening of existing regulatory agencies to the role of professional regulatory bodies. The book analyses the adequacy of current governance arrangements within African countries, and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries. It book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the areas of health research, biomedical ethics, health law and regulation in developing countries.

Download or read book Impacts of Innovation and Cognition in Management written by Bataglia, Walter and published by IGI Global. This book was released on 2024-10-18 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: In today’s business landscape, the intersections between innovation and cognition play a crucial role in shaping current management practices. As organizations strive to remain competitive, leaders must foster innovative thinking while understanding which cognitive processes drive decision-making and problem-solving. Such management strategies assist business leaders in navigating complex challenges, harnessing creativity, and cultivating an adaptive workplace culture. Exploring how innovation and cognition influence strategic choices is necessary for companies looking to enhance responses to change, making room for sustained growth and success in a constantly shifting business environment. Impacts of Innovation and Cognition in Management explores the effects of innovative strategies and technologies, as well as cognitive psychology, in management practices for businesses and organizations. The impact on sustainability and organizational development is examined, along with the usefulness of technologies like artificial intelligence, machine learning, and data analytics. This book covers topics such as absorptive capacity, data science, and cognitive psychology, and is a useful resource for business owners, managers, psychologists, economists, data scientists, researchers, and academicians.

Download or read book Organization and Administration of the Military Research and Development Programs written by United States. Congress. House. Committee on Government Operations and published by . This book was released on 1954 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Army R D A written by and published by . This book was released on 1985-09 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Hearings on Cost Escalation in Defense Procurement Contracts and Military Posture and H R 6722 written by United States. Congress. House. Committee on Armed Services and published by . This book was released on 1973 with total page 1552 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Reflections written by David Atlas and published by Springer. This book was released on 2015-03-30 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the spirited recollections and observations of David Atlas, one of the founding fathers of radar meteorology. During his career, Atlas solved many puzzles and invented numerous techniques that transformed a fledgling application into a vital scientific and operational meteorological tool. This is the story of his incredible career in his own words.

Download or read book Army RD A Bulletin written by and published by . This book was released on 1985 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Army RD A Magazine written by and published by . This book was released on 1985 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Case Studies in Modern Drug Discovery and Development written by Xianhai Huang and published by John Wiley & Sons. This book was released on 2012-05-29 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.