Report of the Paediatric Regulatory Network meeting, 12-13 May 2022


Book Description

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.




Transforming the Workforce for Children Birth Through Age 8


Book Description

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.




WHO guideline on country pharmaceutical pricing policies


Book Description

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.




Screens and Teens


Book Description

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.




Pain Management and the Opioid Epidemic


Book Description

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.




Child Care and Child Development


Book Description

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.




Pediatric Swallowing and Feeding


Book Description

Pediatric Swallowing and Feeding: Assessment and Management, Third Edition provides information to practitioners interested in and involved with children who demonstrate swallowing and feeding disorders. Since the 2002 publication of the second edition, there has been an exponential increase in the number of medically fragile and complex children with swallowing/feeding disorders. A corresponding proliferation in the related basic and clinical research has resulted in the increased appreciation of the complicated inter-relationships between structures and systems that contribute to swallowing/feeding development, function, and disorders. Case studies throughout the book provide examples for decision making and highlight salient points. New to the Third Edition: * Maureen A. Lefton-Greif, PhD, CCC-SLP, BCS-S, is welcomed as co-editor. She brings extensive research expertise and clinical practice in pediatric dysphagia and feeding. * All chapters contain significant updated evidence-based research and clinical information. * New chapters focus on the genetic testing and conditions associated with swallowing and feeding disorders, and the pulmonary manifestations and management of aspiration. * World Health Organization (WHO) description of an International Classification of Functioning, Disability, and Health (ICF) sets the stage for an in-depth discussion of clinical feeding evaluation procedures, interpretation, and management decision making. Pediatric Swallowing and Feeding continues to be the leading text on pediatric dysphagia that provides practical information for clinicians seeing children with swallowing and feeding disorders. The overall importance of an appropriate fund of knowledge and shared experience employing team approaches is emphasized throughout this third edition as in the earlier editions of this book. From the Foreword: "The Editors have recognized the advances and changes in the understanding in the information now available for the care of pediatric swallowing and feeding challenges. They have recruited an outstanding group of contributors for this newest edition. There are numerous critically important updates and additions in the third edition. They have included World Health Organizations International Classification of Functioning, Disability and Health is the functional basis in all areas of the book. This text has its importance as there has been an increased number of children with complex medical and healthcare conditions which are risk for feeding and swallowing disorders. This edition stresses the need for team approaches and also documents the use of “virtual” teams ...Pediatric Swallowing and Feeding: Assessment and Management, Third Edition is the fundamental holistic source for all healthcare providers providing the care for swallowing and feeding in children. This book will be utilized by all caring for children with feeding and swallowing problems throughout the world. The previous editions have been and now this updated third edition continues to be the standard source for the information concerning diagnosis and care of these children." —Robert J. Ruben, MD, FAAP, FACS Distinguished University Professor Departments of Otorhinolaryngology – Head and Neck Surgery and Pediatrics Albert Einstein College of Medicine Montefiore Medical Center Bronx, New York




Childhood Acute Lymphoblastic Leukemia


Book Description

This book provides a comprehensive and up-to-date review of all aspects of childhood Acute Lymphoblastic Leukemia, from basic biology to supportive care. It offers new insights into the genetic pre-disposition to the condition and discusses how response to early therapy and its basic biology are utilized to develop new prognostic stratification systems and target therapy. Readers will learn about current treatment and outcomes, such as immunotherapy and targeted therapy approaches. Supportive care and management of the condition in resource poor countries are also discussed in detail. This is an indispensable guide for research and laboratory scientists, pediatric hematologists as well as specialist nurses involved in the care of childhood leukemia.







The Difficult Airway


Book Description

The Difficult Airway provides a comprehensive textual and visual coverage of how to deal with patients who have expected or unexpected difficult airways. The text begins with a description of the incidence and importance of the difficult airway and then describes the ASA Difficult Airway Algorithm created to facilitate the management of “difficult airways.” The majority of the book features a comprehensive step-by-step approach to the rescue techniques listed as part of the ASA Algorithm. Noted experts in each of the techniques have been recruited by the book editors to present the information. Figures throughout the book illustrate important points and procedures. This is a wonderful resource for professionals in the health care field including anesthesiologists, intensive care physicians, emergency room physicians, nurses, and out-of-hospital first responders.