Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022

Author : World Health Organization
Publisher : World Health Organization
Page : 31 pages
File Size : 51,7 Mb
Release : 2024-04-19
Category : Business & Economics
ISBN : 9789240091276

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Report of the Paediatric Regulatory Network meeting, 12-13 May 2022 by World Health Organization Pdf

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.

Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
Page : 840 pages
File Size : 43,5 Mb
Release : 2023-01-10
Category : Law
ISBN : 9789403530239

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Guide to EU and UK Pharmaceutical Regulatory Law by Sally Shorthose Pdf

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.

Author : National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on the Science of Children Birth to Age 8: Deepening and Broadening the Foundation for Success
Publisher : National Academies Press
Page : 706 pages
File Size : 54,5 Mb
Release : 2015-07-23
Category : Social Science
ISBN : 9780309324885

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Transforming the Workforce for Children Birth Through Age 8 by National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on the Science of Children Birth to Age 8: Deepening and Broadening the Foundation for Success Pdf

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.

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children
Publisher : National Academies Press
Page : 525 pages
File Size : 47,5 Mb
Release : 2016-11-21
Category : Social Science
ISBN : 9780309388573

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Parenting Matters by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children Pdf

Decades of research have demonstrated that the parent-child dyad and the environment of the familyâ€"which includes all primary caregiversâ€"are at the foundation of children's well- being and healthy development. From birth, children are learning and rely on parents and the other caregivers in their lives to protect and care for them. The impact of parents may never be greater than during the earliest years of life, when a child's brain is rapidly developing and when nearly all of her or his experiences are created and shaped by parents and the family environment. Parents help children build and refine their knowledge and skills, charting a trajectory for their health and well-being during childhood and beyond. The experience of parenting also impacts parents themselves. For instance, parenting can enrich and give focus to parents' lives; generate stress or calm; and create any number of emotions, including feelings of happiness, sadness, fulfillment, and anger. Parenting of young children today takes place in the context of significant ongoing developments. These include: a rapidly growing body of science on early childhood, increases in funding for programs and services for families, changing demographics of the U.S. population, and greater diversity of family structure. Additionally, parenting is increasingly being shaped by technology and increased access to information about parenting. Parenting Matters identifies parenting knowledge, attitudes, and practices associated with positive developmental outcomes in children ages 0-8; universal/preventive and targeted strategies used in a variety of settings that have been effective with parents of young children and that support the identified knowledge, attitudes, and practices; and barriers to and facilitators for parents' use of practices that lead to healthy child outcomes as well as their participation in effective programs and services. This report makes recommendations directed at an array of stakeholders, for promoting the wide-scale adoption of effective programs and services for parents and on areas that warrant further research to inform policy and practice. It is meant to serve as a roadmap for the future of parenting policy, research, and practice in the United States.

Author : Anonim
Publisher : World Health Organization
Page : 70 pages
File Size : 40,6 Mb
Release : 2020-09-29
Category : Business & Economics
ISBN : 9789240011878

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WHO guideline on country pharmaceutical pricing policies by Anonim Pdf

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.

Author : Institute of Medicine,Board on Health Care Services,Committee on the Health Professions Education Summit
Publisher : National Academies Press
Page : 191 pages
File Size : 53,9 Mb
Release : 2003-07-01
Category : Medical
ISBN : 9780309133197

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Health Professions Education by Institute of Medicine,Board on Health Care Services,Committee on the Health Professions Education Summit Pdf

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.

Author : Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors
Publisher : National Academies Press
Page : 481 pages
File Size : 52,7 Mb
Release : 2007-01-11
Category : Medical
ISBN : 9780309101479

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Preventing Medication Errors by Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 8 pages
File Size : 40,7 Mb
Release : 1995
Category : Drugs
ISBN : MINN:31951D01343531S

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The Extent of Population Exposure to Assess Clinical Safety by Anonim Pdf

Author : Kathy Koch
Publisher : Moody Publishers
Page : 256 pages
File Size : 53,9 Mb
Release : 2015-02-18
Category : Religion
ISBN : 9780802492944

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Screens and Teens by Kathy Koch Pdf

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.

Author : World Health Organization
Publisher : World Health Organization
Page : 211 pages
File Size : 41,6 Mb
Release : 2015-08-05
Category : Medical
ISBN : 9789241564861

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Investing to Overcome the Global Impact of Neglected Tropical Diseases by World Health Organization Pdf

"The presence, or absence, of neglected tropical diseases (NTDs) can be seen as a proxy for poverty and for the success of interventions aimed at reducing poverty. Today, coverage of the public-health interventions recommended by the World Health Organization (WHO) against NTDs may be interpreted as a proxy for universal health coverage and shared prosperity - in short, a proxy for coverage against neglect. As the world's focus shifts from development to sustainable development, from poverty eradication to shared prosperity, and from disease-specific goals to universal health coverage, control of NTDs will assume an important role towards the target of achieving universal health coverage, including individual financial risk protection. Success in overcoming NTDs is a "litmus test" for universal health coverage against NTDs in endemic countries. The first WHO report on NTDs (2010) set the scene by presenting the evidence for how these interventions had produced results. The second report (2013) assessed the progress made in deploying them and detailed the obstacles to their implementation. This third report analyses for the first time the investments needed to achieve the scale up of implementation required to achieve the targets of the WHO Roadmap on NTDs and universal coverage against NTDs. INVESTING TO OVERCOME THE GLOBAL IMPACT OF NEGLECTED TROPICAL DISEASES presents an investment strategy for NTDs and analyses the specific investment case for prevention, control, elimination and eradication of 12 of the 17 NTDs. Such an analysis is justified following the adoption by the Sixty-sixth World Health Assembly in 2013 of resolution WHA6612 on neglected tropical diseases, which called for sufficient and predictable funding to achieve the Roadmap's targets and sustain control efforts. The report cautions, however, that it is wise investment and not investment alone that will yield success. The report registers progress and challenges and signals those that lie ahead. Climate change is expected to increase the spread of several vector-borne NTDs, notably dengue, transmission of which is directly influenced by temperature, rainfall, relative humidity and climate variability primarily through their effects on the vector. Investments in vector-borne diseases will avoid the potentially catastrophic expenditures associated with their control. The presence of NTDs will thereby signal an early warning system for climate-sensitive diseases. The ultimate goal is to deliver enhanced and equitable interventions to the most marginalized populations in the context of a changing public-health and investment landscape to ensure that all peoples affected by NTDs have an opportunity to lead healthier and wealthier lives."--Publisher's description.

Author : Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization
Publisher : Unknown
Page : 392 pages
File Size : 54,9 Mb
Release : 2006
Category : Immunization
ISBN : 0660193922

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Canadian Immunization Guide by Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization Pdf

The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.

Author : Michael Richard Cohen
Publisher : American Pharmacist Associa
Page : 707 pages
File Size : 53,9 Mb
Release : 2007
Category : Medical
ISBN : 9781582120928

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Medication Errors by Michael Richard Cohen Pdf

In this expanded 600+ page edition, Dr. Cohen brings together some 30 experts from pharmacy, medicine, nursing, and risk management to provide the most current thinking about the causes of medication errors and strategies to prevent them.

Author : Leslie Neal-Boylan
Publisher : Springer Publishing Company
Page : 226 pages
File Size : 43,6 Mb
Release : 2012-10-12
Category : Medical
ISBN : 9780826110107

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Nurses With Disabilities by Leslie Neal-Boylan Pdf

" This is the first research-based book to confront workplace issues facing nurses who have disabilities. It not only examines in depth their experiences, roadblocks to successful employment, and misperceptions surrounding them, but also provides viable solutions for creating positive attitudes towards them and a welcoming work environment that fosters hiring and retention. From the perspectives and actual voices of nurses with disabilities, nurse leaders, nurse administrators, and patients, the book identifies nurses with disabilities (including sensory, musculoskeletal, emotional, and mental health issues), discusses why they choose to leave nursing or hide their disabilities, and analyzes how their disabilities may influence career choices. "

Author : Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe
Publisher : Public Health Foundation
Page : 512 pages
File Size : 50,8 Mb
Release : 2015-10-19
Category : Health & Fitness
ISBN : 9780990449126

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Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition E-Book by Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe Pdf

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact [email protected] for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

Author : Mark A. Sperling
Publisher : Unknown
Page : 0 pages
File Size : 53,7 Mb
Release : 2005
Category : Children
ISBN : 141602753X

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Diabetes Mellitus in Children by Mark A. Sperling Pdf