Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240102345
Category : Medical
Languages : en
Pages : 25
Book Description
The GAP-f Phase 2 Progress Report highlights the network’s achievements and milestones from 2022 to 2024, providing a transparent overview of its impact. The report offers open, transparent, and comprehensive accountability to GAP-f’s partners, supporters, and beneficiaries, highlighting the impact of collaborative initiatives. By showcasing progress, pinpointing areas for continued focus, and sharing insights gained, the report serves as a vital tool for sustaining trust and engagement with stakeholders and guiding the planning and focus of GAP-f’s next strategic phase.
Accelerating research, development and access to paediatric medicines
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240102345
Category : Medical
Languages : en
Pages : 25
Book Description
The GAP-f Phase 2 Progress Report highlights the network’s achievements and milestones from 2022 to 2024, providing a transparent overview of its impact. The report offers open, transparent, and comprehensive accountability to GAP-f’s partners, supporters, and beneficiaries, highlighting the impact of collaborative initiatives. By showcasing progress, pinpointing areas for continued focus, and sharing insights gained, the report serves as a vital tool for sustaining trust and engagement with stakeholders and guiding the planning and focus of GAP-f’s next strategic phase.
Publisher: World Health Organization
ISBN: 9240102345
Category : Medical
Languages : en
Pages : 25
Book Description
The GAP-f Phase 2 Progress Report highlights the network’s achievements and milestones from 2022 to 2024, providing a transparent overview of its impact. The report offers open, transparent, and comprehensive accountability to GAP-f’s partners, supporters, and beneficiaries, highlighting the impact of collaborative initiatives. By showcasing progress, pinpointing areas for continued focus, and sharing insights gained, the report serves as a vital tool for sustaining trust and engagement with stakeholders and guiding the planning and focus of GAP-f’s next strategic phase.
Shaping the global innovation and access landscape for better paediatric medicines
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240044647
Category : Medical
Languages : en
Pages : 48
Book Description
GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.
Publisher: World Health Organization
ISBN: 9240044647
Category : Medical
Languages : en
Pages : 48
Book Description
GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.
Guide to Paediatric Drug Development and Clinical Research
Author: K. Rose
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805593635
Category : Medical
Languages : en
Pages : 240
Book Description
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805593635
Category : Medical
Languages : en
Pages : 240
Book Description
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Pediatric Cancer Therapeutics Development
Author: Jorge DiMartino
Publisher: Springer Nature
ISBN: 3031063570
Category : Medical
Languages : en
Pages : 184
Book Description
This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.
Publisher: Springer Nature
ISBN: 3031063570
Category : Medical
Languages : en
Pages : 184
Book Description
This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Report of the Paediatric Regulatory Network meeting, 12-13 May 2022
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240091270
Category : Business & Economics
Languages : en
Pages : 31
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.
Publisher: World Health Organization
ISBN: 9240091270
Category : Business & Economics
Languages : en
Pages : 31
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.
Paediatric drug optimization for COVID-19
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240068198
Category : Medical
Languages : en
Pages : 27
Book Description
This meeting report summarizes the prioritization exercise for COVID-19 medications using the Paediatric Drug Optimization (PADO) process to identify research gaps and accelerate formulations under the umbrella of the Global Accelerator for Paediatric formulations (GAP-f). The target audience are policy makers, academic institutions, and NGOs.
Publisher: World Health Organization
ISBN: 9240068198
Category : Medical
Languages : en
Pages : 27
Book Description
This meeting report summarizes the prioritization exercise for COVID-19 medications using the Paediatric Drug Optimization (PADO) process to identify research gaps and accelerate formulations under the umbrella of the Global Accelerator for Paediatric formulations (GAP-f). The target audience are policy makers, academic institutions, and NGOs.
Initiation task force meeting for the Paediatric Regulatory Network
Author:
Publisher: World Health Organization
ISBN: 9240050264
Category : Medical
Languages : en
Pages : 22
Book Description
Publisher: World Health Organization
ISBN: 9240050264
Category : Medical
Languages : en
Pages : 22
Book Description
Essentials of Translational Pediatric Drug Development
Author: Elke Gasthuys
Publisher: Elsevier
ISBN: 0323904297
Category : Medical
Languages : en
Pages : 732
Book Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Publisher: Elsevier
ISBN: 0323904297
Category : Medical
Languages : en
Pages : 732
Book Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Paediatric drug optimization for antibiotics
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240068937
Category : Medical
Languages : en
Pages : 27
Book Description
Publisher: World Health Organization
ISBN: 9240068937
Category : Medical
Languages : en
Pages : 27
Book Description