Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022
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Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-04-19
Report Of The Paediatric Regulatory Network Meeting 12 13 May 2022 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-19 with Business & Economics categories.
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.
Who Guideline On Country Pharmaceutical Pricing Policies
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Author :
language : en
Publisher: World Health Organization
Release Date : 2020-09-29
Who Guideline On Country Pharmaceutical Pricing Policies written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-29 with Business & Economics categories.
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.
The Asean Charter
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Author : ASEAN.
language : en
Publisher:
Release Date : 2008
The Asean Charter written by ASEAN. and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Regionalism categories.
Guide To Eu And Uk Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2023-01-10
Guide To Eu And Uk Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-10 with Law categories.
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.
Who Expert Committee On Specifications For Pharmaceutical Preparations
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-04-26
Who Expert Committee On Specifications For Pharmaceutical Preparations written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-26 with Medical categories.
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.
Transforming The Workforce For Children Birth Through Age 8
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2015-07-23
Transforming The Workforce For Children Birth Through Age 8 written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-23 with Social Science categories.
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.
The Extent Of Population Exposure To Assess Clinical Safety
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Author :
language : en
Publisher:
Release Date : 1995
The Extent Of Population Exposure To Assess Clinical Safety written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Drugs categories.
The Health Benefits Of Fruits And Vegetables
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Author : Mercedes Del Río Celestino
language : en
Publisher: MDPI
Release Date : 2020-05-27
The Health Benefits Of Fruits And Vegetables written by Mercedes Del Río Celestino and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-27 with Science categories.
This Special Issue gathers 14 original research papers to disseminate new data on phytochemicals from vegetables and fruits, which are recommended for their health-promoting properties. Epidemiological, toxicological and nutritional studies suggest an association between fruit and vegetable consumption and lower incidence of chronic diseases, such as coronary heart problems, cancer, diabetes, and Alzheimer’s disease. In this Special Issue the following topics have been addressed: (i) the protective roles, antioxidant and others bioactivities such as genotoxic and antigenotoxic effects in the Drosophila melanogaster animal genetic model and pro-apoptotic capacities against cancer processes, including cytotoxicity and clastogenic DNA activity, using an in vitro human cancer model (HL-60 cell line, (ii), new sustainable approaches based on near-infrared spectroscopy to determine the quality, (iii) broad-scale metabolomic investigation for the development of functional food and, (iv) processing techniques that can modify the initial nutritional and antioxidant content of fruits, vegetables, and additives. In summary, the information in this Special Issue will be interesting for researchers in this field and the general public interested in the relationship between vegetables and health.
Screens And Teens
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Author : Kathy Koch
language : en
Publisher: Moody Publishers
Release Date : 2015-02-18
Screens And Teens written by Kathy Koch and has been published by Moody Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-18 with Religion categories.
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.
Tumors In Adolescents And Young Adults
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Author : Daniel P. Stark
language : en
Publisher: Karger Medical Scientific
Release Date : 2016
Tumors In Adolescents And Young Adults written by Daniel P. Stark and has been published by Karger Medical Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Cancer in children categories.
The field of adolescents and young adult (AYA) oncology is experiencing a very challenging time. This book is a guide to the key issues for any clinician and health professional managing AYA with cancer in Europe. Emphasis is on collaboration between adult and pediatric specialists. Authors present their perception of the current state of the most prominent primary issues in AYA oncology. Chapters cover cross-cutting issues such as disease epidemiology, systems of care, access to innovative therapy and late effects of treatment and survivorship for AYA-onset cancers. There are discussions of the latest developments and the most important cancer types for AYA, including the shared perspectives of adult and pediatric specialists. Throughout the book recurrent challenges to the AYA community are exposed and solutions proposed. Tumors in Adolescents and Young Adults is highly recommended to any oncologist or haematologist treating patients aged 15 to 39 diagnosed with cancer. It will also be of interest to other members of the multidisciplinary teams involved with this patient group.