Download or read book Clinical Research in Asia written by U Sahoo and published by Elsevier. This book was released on 2012-05-25 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research
Download or read book Asia Pacific s Growing Role in Global Clinical Trials written by Sara Gambrill and published by . This book was released on 2008-02-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-04-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios
Download or read book Global Clinical Trials written by Richard Chin and published by Academic Press. This book was released on 2011-05-06 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA
Download or read book Clinical Trials and GCP in East Asia written by Drug Information Association and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Multi Dimensional Survey and Critical Analysis of Clinical Trial Regulations in Hong Kong and a Comparison of the Status of Clinical Trial Regulations in Some Asian Countries Regions written by Hung-Kin Clive Chan and published by Open Dissertation Press. This book was released on 2017-01-27 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This dissertation, "A multi-dimensional survey and critical analysis of clinical trial regulations in Hong Kong and a comparison of the status of clinical trial regulations in some Asian countries/Regions" by Hung-kin, Clive, Chan, 陳鴻健, was obtained from The University of Hong Kong (Pokfulam, Hong Kong) and is being sold pursuant to Creative Commons: Attribution 3.0 Hong Kong License. The content of this dissertation has not been altered in any way. We have altered the formatting in order to facilitate the ease of printing and reading of the dissertation. All rights not granted by the above license are retained by the author. DOI: 10.5353/th_b3197146 Subjects: Clinical trials - China - Hong Kong Drugs - China - Hong Kong - Testing Biotechnology - China - Hong Kong Clinical trials - Asia
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2013-03-27 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Download or read book Challenges in Conducting Clinical Trials in Asia Ethical Considerations abstract written by C. C. Lang and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Download or read book Introduction to Clinical Trials written by and published by . This book was released on 1998 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Health Care Policy In East Asia A World Scientific Reference In 4 Volumes written by and published by World Scientific. This book was released on 2019-11-25 with total page 1278 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past three decades, health care systems in the East Asian regions of China, Japan, South Korea, and Taiwan have undergone major changes. Each system has its unique achievements and challenges. Global health care policymakers are increasingly interested in understanding the changes that have taken place in these four systems. This four-volume reference set is designed to help health care professionals, academics, policymakers, and general readers gain a good grasp of the background and latest developments in the health care systems of China, Japan, South Korea, and Taiwan. This reference set provides an in-depth comparative health policy analysis and discussion of health care reform strategies in each of these systems. One unique feature of this set is that each volume has been edited by a leading scholar who has been deeply involved in the development of the health care system in that particular region. Each of these editors also has invited both scholars and practitioners to provide a first-hand description and analysis of key health care reform issues in that system. The many examples provided in each volume demonstrate how findings of evidence-based policy research can be implemented into policy practice.Volume 1 describes and discusses China's ambitious and complex journey of health care reform since 2009. The Chinese government has achieved universal health insurance coverage and has embarked on reforms of the service delivery system and provider payment methods that are aimed at controlling health expenditure growth and improving efficiency. This volume includes pilot and social experiments initiated by the government and researchers and their evaluations that have guided the formulation of health reform policies. It provides information on how to make reforms work at the local and provincial levels. The findings detailed in this volume will contribute to a global knowledge base in health care reforms.Volume 2 provides a comprehensive review and evaluation of the Japanese health care system. Japan has a long history of health care system development and provision of universal health coverage, with a mature and well-developed health care system among East Asian countries. However, due to increases in health care costs, economic stagnation and the country's rapidly aging population, Japan has undergone significant health care reform during the last two decades, both in the delivery as well as financing of health services in its hospital sector, medical technology sector and long-term care insurance. Despite these challenges and reforms, health outcomes among the Japanese population have been progressively among the best in the world. This volume shows how policy research can lead to policy analysis, implementation and assessment. It also provides valuable lessons learnt for mutual learning among other health care systems.Volume 3 offers a comprehensive review of the developments in South Korea's national health insurance system since 1989 in terms of financing, delivery systems, and outcomes. The volume analyzes the efficiency of cost and service delivery by public sectors versus private sectors. It points out areas of challenge to future Korean health care reform. Chapter authors in this volume are leading experts involved in Korean health care policy implementation.Volume 4 reviews the development and achievements of Taiwan Health Insurance since 1995. Because of its continuous reform in payment, services delivery, and pharmaceutical technology, Taiwan has been considered a model example of universal health insurance among global health systems. This volume shows the processes used to translate policy research findings into policy changes. While the health care reform in Taiwan is ongoing, the Taiwan example provides a real-world and practical understanding of health care system changes.In summary, this four-volume set makes an outstanding contribution to health care system reform and policy research, based on solid scholarly work. It also introduces policy researchers and academic communities to current debates about health systems, health financing, and universal health coverage. This reference volume is a must for anyone keen on East Asia's health care system reform dynamics and changing scene.
Download or read book Stem Cell Research Third Annual Asia Pacific Congress written by and published by . This book was released on 2005 with total page 3 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global Clinical Trials for Alzheimer s Disease written by Nadina C. Jose and published by Elsevier Inc. Chapters. This book was released on 2013-08-28 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: The incidence of Alzheimer’s disease is increasing worldwide. The need to fortify global resources conducting clinical trials becomes of paramount importance for sponsors to ensure less delay in marketing their products. This chapter provides a concise and practical approach to building capacity and capability in emerging or developing markets. Lessons learned from countries like China and India, where the top 12 pharmaceutical and biotech companies have become deeply entrenched in the last 10 years, serve as important benchmarks which can be referenced as new emerging markets like Vietnam, Indonesia, and the Philippines establish themselves as available and capable areas for clinical trials. Referenced case studies describe actual events from which valuable practical pearls can be adapted in other settings. Sponsors need to recognize that investing early on in developing project teams that can support these trials creates a better landscape for success.
Download or read book Clinical Research Center written by United States and published by . This book was released on 1963 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Textbook of Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Download or read book Aging in Asia written by National Research Council and published by National Academies Press. This book was released on 2012-07-31 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: The population of Asia is growing both larger and older. Demographically the most important continent on the world, Asia's population, currently estimated to be 4.2 billion, is expected to increase to about 5.9 billion by 2050. Rapid declines in fertility, together with rising life expectancy, are altering the age structure of the population so that in 2050, for the first time in history, there will be roughly as many people in Asia over the age of 65 as under the age of 15. It is against this backdrop that the Division of Behavioral and Social Research at the U.S. National Institute on Aging (NIA) asked the National Research Council (NRC), through the Committee on Population, to undertake a project on advancing behavioral and social research on aging in Asia. Aging in Asia: Findings from New and Emerging Data Initiatives is a peer-reviewed collection of papers from China, India, Indonesia, Japan, and Thailand that were presented at two conferences organized in conjunction with the Chinese Academy of Sciences, Indian National Science Academy, Indonesian Academy of Sciences, and Science Council of Japan; the first conference was hosted by the Chinese Academy of Social Sciences in Beijing, and the second conference was hosted by the Indian National Science Academy in New Delhi. The papers in the volume highlight the contributions from new and emerging data initiatives in the region and cover subject areas such as economic growth, labor markets, and consumption; family roles and responsibilities; and labor markets and consumption.
