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Book Report of the Paediatric Regulatory Network meeting  12 13 May 2022

Download or read book Report of the Paediatric Regulatory Network meeting 12 13 May 2022 written by World Health Organization and published by World Health Organization. This book was released on 2024-04-19 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Paediatric Regulatory Network was initially created as a global paediatric working group in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the World Health Organization (WHO) Better Medicines for Children Project in collaboration with the Bill & Melinda Gates Foundation, to offer a platform for discussion on paediatric regulatory considerations for national regulatory authorities. The Network was reactivated in December 2019 as a global paediatric network supporting the availability of quality-assured medical products for children, by facilitating communication, collaboration, training and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medical products. The Network’s activities contribute efficiently to the implementation of World Health Assembly resolutions WHA60.20 (2007) on better medicines for children, WHA69.20 (2016) on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, WHA67.20 (2014) on regulatory system strengthening for medical products and WHA67.22 (2014) on access to essential medicines.

Book Transforming the Workforce for Children Birth Through Age 8

Download or read book Transforming the Workforce for Children Birth Through Age 8 written by National Research Council and published by National Academies Press. This book was released on 2015-07-23 with total page 587 pages. Available in PDF, EPUB and Kindle. Book excerpt: Children are already learning at birth, and they develop and learn at a rapid pace in their early years. This provides a critical foundation for lifelong progress, and the adults who provide for the care and the education of young children bear a great responsibility for their health, development, and learning. Despite the fact that they share the same objective - to nurture young children and secure their future success - the various practitioners who contribute to the care and the education of children from birth through age 8 are not acknowledged as a workforce unified by the common knowledge and competencies needed to do their jobs well. Transforming the Workforce for Children Birth Through Age 8 explores the science of child development, particularly looking at implications for the professionals who work with children. This report examines the current capacities and practices of the workforce, the settings in which they work, the policies and infrastructure that set qualifications and provide professional learning, and the government agencies and other funders who support and oversee these systems. This book then makes recommendations to improve the quality of professional practice and the practice environment for care and education professionals. These detailed recommendations create a blueprint for action that builds on a unifying foundation of child development and early learning, shared knowledge and competencies for care and education professionals, and principles for effective professional learning. Young children thrive and learn best when they have secure, positive relationships with adults who are knowledgeable about how to support their development and learning and are responsive to their individual progress. Transforming the Workforce for Children Birth Through Age 8 offers guidance on system changes to improve the quality of professional practice, specific actions to improve professional learning systems and workforce development, and research to continue to build the knowledge base in ways that will directly advance and inform future actions. The recommendations of this book provide an opportunity to improve the quality of the care and the education that children receive, and ultimately improve outcomes for children.

Book WHO guideline on country pharmaceutical pricing policies

Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Book Guide to EU and UK Pharmaceutical Regulatory Law

Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Book WHO Expert Committee on Specifications for Pharmaceutical Preparations

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by and published by World Health Organization. This book was released on 2021-04-26 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity; WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures; WHO/United Nations Population Fund guidance on testing of male latex condoms; WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms; WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce; Good reliance practices in the regulation of medical products: high-level principles and considerations; and Good regulatory practices in the regulations of medical products. All of the above are included in this report and recommended for implementation.

Book Screens and Teens

    Book Details:
  • Author : Kathy Koch
  • Publisher : Moody Publishers
  • Release : 2015-02-18
  • ISBN : 0802492940
  • Pages : 256 pages

Download or read book Screens and Teens written by Kathy Koch and published by Moody Publishers. This book was released on 2015-02-18 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you feel like you’re losing your teen to technology, you’re not alone. Screen time is rapidly replacing family time, and for teens especially, it is hardwiring the way they connect with their world. In Screens and Teens, Dr. Kathy helps you make sense of all this and empowers you to respond. She: Exposes the lies that technology can teach your teen Guides you in countering those lies with biblical truths and helpful practices Shares success stories of families who have cut back on technology and prioritized each other Kathy’s research, experience, and relatability all come together for an inspiring book, sure to help you be closer with your kids. "Dr. Kathy continues to inform and inspire me with Screens and Teens. I feel better equipped to parent my kids in our constantly changing world because of her wisdom. Dr. Kathy’s expertise makes her my "go-to" person when I have questions about technology and the way it affects our family. Whether you have kids or not, this book will make you more aware of the tech-driven world we live in and encourage you to make bold, smart choices." -Kirk Cameron, Actor/Producer Grab a pen and get ready to underline, circle, and write "That’s so us!" in the margins. Be equipped to keep your family connected. BONUS: Every book includes an access code to stream or download a powerful 9-session video series (valued at $20) for FREE! In these videos, Dr. Kathy presents eye-opening insights to help you connect with your teen in a whole new way. Designed to be watched prior to reading each chapter, they will help you to engage the book on a deeper level.

Book Child Care and Child Development

Download or read book Child Care and Child Development written by NICHD Early Child Care Research Network and published by Guilford Press. This book was released on 2005-12-23 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: This important work presents the results of the most comprehensive scientific study to date of early child care and its relation to child development. In one volume, a critical selection of material from the most salient journal articles is brought together with new overviews and a concluding commentary. Provided is a wealth of authoritative information about the ways in which nonmaternal care is linked to health, psychological adjustment, and mother-child bonds in the first six years of life. The study addresses the full complexity of this vital issue, taking into account a range of family characteristics as well as the quality of child care experiences. An essential resource for developmentalists, early child care specialists, and educators, this volume offers compelling new perspectives on practice, policy, and research.

Book Educating the Student Body

    Book Details:
  • Author : Committee on Physical Activity and Physical Education in the School Environment
  • Publisher : National Academies Press
  • Release : 2013-11-13
  • ISBN : 0309283140
  • Pages : 503 pages

Download or read book Educating the Student Body written by Committee on Physical Activity and Physical Education in the School Environment and published by National Academies Press. This book was released on 2013-11-13 with total page 503 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physical inactivity is a key determinant of health across the lifespan. A lack of activity increases the risk of heart disease, colon and breast cancer, diabetes mellitus, hypertension, osteoporosis, anxiety and depression and others diseases. Emerging literature has suggested that in terms of mortality, the global population health burden of physical inactivity approaches that of cigarette smoking. The prevalence and substantial disease risk associated with physical inactivity has been described as a pandemic. The prevalence, health impact, and evidence of changeability all have resulted in calls for action to increase physical activity across the lifespan. In response to the need to find ways to make physical activity a health priority for youth, the Institute of Medicine's Committee on Physical Activity and Physical Education in the School Environment was formed. Its purpose was to review the current status of physical activity and physical education in the school environment, including before, during, and after school, and examine the influences of physical activity and physical education on the short and long term physical, cognitive and brain, and psychosocial health and development of children and adolescents. Educating the Student Body makes recommendations about approaches for strengthening and improving programs and policies for physical activity and physical education in the school environment. This report lays out a set of guiding principles to guide its work on these tasks. These included: recognizing the benefits of instilling life-long physical activity habits in children; the value of using systems thinking in improving physical activity and physical education in the school environment; the recognition of current disparities in opportunities and the need to achieve equity in physical activity and physical education; the importance of considering all types of school environments; the need to take into consideration the diversity of students as recommendations are developed. This report will be of interest to local and national policymakers, school officials, teachers, and the education community, researchers, professional organizations, and parents interested in physical activity, physical education, and health for school-aged children and adolescents.

Book Diabetes Mellitus in Children

Download or read book Diabetes Mellitus in Children written by Mark A. Sperling and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Health Professions Education

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2003-07-01
  • ISBN : 030913319X
  • Pages : 191 pages

Download or read book Health Professions Education written by Institute of Medicine and published by National Academies Press. This book was released on 2003-07-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.

Book Children  Adolescents  and the Media

Download or read book Children Adolescents and the Media written by Victor C. Strasburger and published by SAGE Publications, Incorporated. This book was released on 2002-03-26 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking an approach grounded in the media effects tradition, this book provides a comprehensive, research-oriented treatment of how children and adolescents interact with the media. Chapters review the latest findings as well as seminal studies that have helped frame the issues in such areas as advertising, violence, video games, sexuality, drugs, body image and eating disorders, music, and the Internet. Each chapter is liberally sprinkled with illustrations, examples from the media, policy debates, and real-life instances of media impact.

Book World Report on Child Injury Prevention

Download or read book World Report on Child Injury Prevention written by M. M. Peden and published by World Health Organization. This book was released on 2008 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Child injuries are largely absent from child survival initiatives presently on the global agenda. Through this report, the World Health Organization, the United Nations Children's Fund and many partners have set out to elevate child injury to a priority for the global public health and development communities. It should be seen as a complement to the UN Secretary-General's study on violence against children released in late 2006 (that report addressed violence-related or intentional injuries). Both reports suggest that child injury and violence prevention programs need to be integrated into child survival and other broad strategies focused on improving the lives of children. Evidence demonstrates the dramatic successes in child injury prevention in countries which have made a concerted effort. These results make a case for increasing investments in human resources and institutional capacities. Implementing proven interventions could save more than a thousand children's lives a day.--p. vii.

Book Preventing Medication Errors

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2007-01-11
  • ISBN : 0309101476
  • Pages : 481 pages

Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2007-01-11 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Book Disease Control Priorities  Third Edition  Volume 8

Download or read book Disease Control Priorities Third Edition Volume 8 written by Donald A. P. Bundy and published by World Bank Publications. This book was released on 2017-11-20 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: More children born today will survive to adulthood than at any time in history. It is now time to emphasize health and development in middle childhood and adolescence--developmental phases that are critical to health in adulthood and the next generation. Child and Adolescent Health and Development explores the benefits that accrue from sustained and targeted interventions across the first two decades of life. The volume outlines the investment case for effective, costed, and scalable interventions for low-resource settings, emphasizing the cross-sectoral role of education. This evidence base can guide policy makers in prioritizing actions to promote survival, health, cognition, and physical growth throughout childhood and adolescence.

Book Closing the Gap in a Generation

    Book Details:
  • Author : WHO Commission on Social Determinants of Health
  • Publisher : World Health Organization
  • Release : 2008
  • ISBN : 9241563702
  • Pages : 257 pages

Download or read book Closing the Gap in a Generation written by WHO Commission on Social Determinants of Health and published by World Health Organization. This book was released on 2008 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Social justice is a matter of life and death. It affects the way people live, their consequent chance of illness, and their risk of premature death. We watch in wonder as life expectancy and good health continue to increase in parts of the world and in alarm as they fail to improve in others.

Book Occupational Therapy Practice Framework  Domain and Process

Download or read book Occupational Therapy Practice Framework Domain and Process written by Aota and published by AOTA Press. This book was released on 2014 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: As occupational therapy celebrates its centennial in 2017, attention returns to the profession's founding belief in the value of therapeutic occupations as a way to remediate illness and maintain health. The founders emphasized the importance of establishing a therapeutic relationship with each client and designing an intervention plan based on the knowledge about a client's context and environment, values, goals, and needs. Using today's lexicon, the profession's founders proposed a vision for the profession that was occupation based, client centered, and evidence based--the vision articulated in the third edition of the Occupational Therapy Practice Framework: Domain and Process. The Framework is a must-have official document from the American Occupational Therapy Association. Intended for occupational therapy practitioners and students, other health care professionals, educators, researchers, payers, and consumers, the Framework summarizes the interrelated constructs that describe occupational therapy practice. In addition to the creation of a new preface to set the tone for the work, this new edition includes the following highlights: a redefinition of the overarching statement describing occupational therapy's domain; a new definition of clients that includes persons, groups, and populations; further delineation of the profession's relationship to organizations; inclusion of activity demands as part of the process; and even more up-to-date analysis and guidance for today's occupational therapy practitioners. Achieving health, well-being, and participation in life through engagement in occupation is the overarching statement that describes the domain and process of occupational therapy in the fullest sense. The Framework can provide the structure and guidance that practitioners can use to meet this important goal.

Book Artificial Intelligence in Medical Imaging

Download or read book Artificial Intelligence in Medical Imaging written by Erik R. Ranschaert and published by Springer. This book was released on 2019-01-29 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging. After an introduction on game changers in radiology, such as deep learning technology, the technological evolution of AI in computing science and medical image computing is described, with explanation of basic principles and the types and subtypes of AI. Subsequent sections address the use of imaging biomarkers, the development and validation of AI applications, and various aspects and issues relating to the growing role of big data in radiology. Diverse real-life clinical applications of AI are then outlined for different body parts, demonstrating their ability to add value to daily radiology practices. The concluding section focuses on the impact of AI on radiology and the implications for radiologists, for example with respect to training. Written by radiologists and IT professionals, the book will be of high value for radiologists, medical/clinical physicists, IT specialists, and imaging informatics professionals.