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In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Proceedings of a Japanese-German International Symposium held in Erfurt, Germany, October 9-10, 1996
Provides a comprehensive introduction to the human, social and economic aspects of science and technology. It is broad, interdisciplinary and international, with a focus on Australia. The authors present complex issues in an accessible and engaging form. Invaluable for both students and teachers.
Explore international trends in health and longevity--with a special focus on older women!This essential book examines the latest research on life expectancy and “active life expectancy”--the number of years that women can expect to live free from major disability--in developed and developing countries around the world. It also explores the policy implications of the contributors’ findings. Here you'll find a global study using data from the World Health Organization, a European study using data from OECD countries, and studies of women in the United Kingdom, Fiji, The Netherlands, Japan, Canada, and the United States.With contributions from demographers, economists, epidemiologists, gerontologists, medical statisticians, policy analysts, physicians, public health directors, and sociologists, International Perspectives on Health Expectancies for Older Women compares mortality and morbidity trends in various populations. In addition to reviewing the current literature on active life expectancy, this informative book looks at: the distribution of total, unimpaired, and impaired life for several groups of older women defined by race, education, and marital history gender differences in health profiles in The Netherlands gender differences in life with and without six major diseases, including both morbid and mortal conditions in the United States how mortality and morbidity patterns differ for Canadian women and men 45 years of age and older, focusing on risk factors and chronic conditions such as low income, low education, abnormal body mass index, lack of physical activity, smoking, cancer, diabetes, and arthritis patterns of healthy life expectancy for older women around the globe a comparison of the development and progression of physical disability in Japanese men and women and more!
This book provides the latest viewpoints of scientific research in the field of e-business. It is organized into three sections: “Higher Education and Digital Economy Development”, “Artificial Intelligence in E-Business”, and “Business Intelligence Applications”. Chapters focus on China’s higher education in e-commerce, digital economy development, natural language processing applications in business, Information Technology Governance, Risk and Compliance (IT GRC), business intelligence, and more.
This book gathers the proceedings of the 7th International Conference, with the theme “Culture and Tourism in a Smart, Globalized and Sustainable World,” held on Hydra Island, Greece, on June 17–19, 2020, published with the support of the International Association of Cultural and Digital Tourism. Highlighting the contributions made by numerous writers to the advancement of tourism research, this book presents a critical academic discourse on sustainable practices in the smart tourism context, improving readers’ understanding of, and stimulating future debates in, this critical area. In addition to the knowledge economy and the concept of smart destinations, the book addresses new modes of tourism management and development, as well as emerging technologies, including location-based services, the Internet of things, smart cities, mobile services, gamification, digital collections and the virtual visitor, social media, social networking, and augmented reality.
Cover -- Title -- Copyright -- Contents -- List of Illustrations -- Notes on Contributors -- Acknowledgements -- 1 The city and its regulations: Unexpected margins -- Part I Space and state regulation: The urban interstices -- 2 Markets and marginality in Beirut -- 3 The tremendous making and unmaking of the peripheries in current Istanbul -- 4 Resilient forms of urbanity on the margins? Al-Kherba: A vivid market in a damaged section of the medina of Tunis -- 5 Whose margins? Marginality, poverty and the moral geography of pre-Soviet Bukhara -- 6 On the margins of the city: Izmir Prison in the late Ottoman Empire -- Part II Diversity and moral policing: Making claims through marginalisation -- 7 'Texas': An off-centre district at the heart of nightlife in Odienné -- 8 The Manyema in colonial Dar es Salaam (Tanzania) between urban margins and regional connections -- 9 On the margins: Suburban space and religious deviancy in Jakarta and Kuala Lumpur -- 10 Ethnic differentiation and conflict dynamics: Uzbeks' marginalisation and non-marginalisation in southern Kyrgyzstan -- Index