Cargando…

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory...

Descripción completa

Detalles Bibliográficos
Autores principales:	Rei Bolislis, Winona, Bejeuhr, Gesine, Benzaghou, Fawzi, Corriol‐Rohou, Solange, Herrero‐Martinez, Esteban, Hildebrand, Heidrun, Hill‐Venning, Claire, Hoogland, Hans, Johnson, Craig, Joos, Angelika, Vart, Richard, Le Visage, Geneviève, Kühler, Thomas C.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	White Papers
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518420/ https://www.ncbi.nlm.nih.gov/pubmed/33411346 http://dx.doi.org/10.1002/cpt.2152

Ejemplares similares

Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels
por: Bowman, Christopher J., et al.
Publicado: (2022)

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)
por: Musuamba, FT, et al.
Publicado: (2017)

From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety
por: Bolislis, Winona Rei R., et al.
Publicado: (2019)

Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
por: Marshall, SF, et al.
Publicado: (2016)

The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting
por: Mofid, Sarah, et al.
Publicado: (2021)

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities
por: Bolislis, Winona Rei, et al.
Publicado: (2021)

A proposal to sequence the genome of a garter snake (Thamnophis sirtalis)
por: Castoe, Todd A., et al.
Publicado: (2011)

Two genome sequences of the same bacterial strain, Gluconacetobacter diazotrophicus PAl 5, suggest a new standard in genome sequence submission
por: Giongo, Adriana, et al.
Publicado: (2010)

Extending Standards for Genomics and Metagenomics Data: A Research Coordination Network for the Genomic Standards Consortium (RCN4GSC)
por: Wooley, John C., et al.
Publicado: (2009)

Studies on Monitoring and Tracking Genetic Resources: An Executive Summary
por: Garrity, George M., et al.
Publicado: (2009)

Conceptualizing a Genomics Software Institute (GSI)
por: Gilbert, Jack A., et al.
Publicado: (2012)

Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles
por: Van Buskirk, Glenn A., et al.
Publicado: (2012)

NonClinical Dose Formulation Analysis Method Validation and Sample Analysis
por: Whitmire, Monica Lee, et al.
Publicado: (2010)

Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety
por: Blum, Alexander B, et al.
Publicado: (2011)

Cephalopod genomics: A plan of strategies and organization
por: Albertin, Caroline B., et al.
Publicado: (2012)

Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm
por: Van Buskirk, Glenn A., et al.
Publicado: (2014)

The National LGBT Cancer Action Plan: A White Paper of the 2014 National Summit on Cancer in the LGBT Communities
por: Burkhalter, Jack E., et al.
Publicado: (2016)

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics
por: Ishii-Watabe, Akiko, et al.
Publicado: (2015)

A Blueprint for Telerehabilitation Guidelines
por: Brennan, David, et al.
Publicado: (2010)

Na(+)/Ca(2+) exchange and Na(+)/K(+)-ATPase in the heart
por: Shattock, Michael J, et al.
Publicado: (2015)

Meeting Report: 1st International Functional Metagenomics Workshop May 7–8, 2012, St. Jacobs, Ontario, Canada.
por: Engel, Katja, et al.
Publicado: (2013)

Gain-of-Function Research: Ethical Analysis
por: Selgelid, Michael J.
Publicado: (2016)

Help, my rating looks bad! Coding comorbidities in arthroplasty
por: Galloway, Joseph D., et al.
Publicado: (2016)

Proceedings of the Working Group Session on Fertility Preservation for Individuals with Gender and Sex Diversity
por: Finlayson, Courtney, et al.
Publicado: (2016)

Postoperative prophylactic antibiotics in total joint arthroplasty
por: Yates, Adolph J.
Publicado: (2018)

The Critical Role of Nonhuman Primates in Medical Research
por: Friedman, Henry, et al.
Publicado: (2017)

Converging on child mental health – toward shared global action for child development
por: Belkin, G., et al.
Publicado: (2017)

Gender Dysphoria in Adults: An Overview and Primer for Psychiatrists
por: Byne, William, et al.
Publicado: (2018)

Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence
por: Hussain, Ajaz S., et al.
Publicado: (2019)

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective
por: Li, Jinjiang, et al.
Publicado: (2019)

Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
por: Azadeh, Mitra, et al.
Publicado: (2019)

White Paper on Electronic Nicotine Delivery System
por: Chakma, Joy Kumar, et al.
Publicado: (2019)

A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need
por: Ermakov, Sergey, et al.
Publicado: (2019)

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing
por: Zaborenko, Nikolay, et al.
Publicado: (2019)

Procedure coding in the American Joint Replacement Registry
por: Cahue, September R., et al.
Publicado: (2019)

Directions for research and training in plant omics: Big Questions and Big Data
por: Argueso, Cristiana T., et al.
Publicado: (2019)

Current management of Duchenne muscular dystrophy in the Middle East: expert report
por: Jumah, Mohammed Al, et al.
Publicado: (2019)

Arabidopsis bioinformatics resources: The current state, challenges, and priorities for the future
Publicado: (2019)

Reinventing postgraduate training in the plant sciences: T‐training defined through modularity, customization, and distributed mentorship
por: Henkhaus, Natalie A., et al.
Publicado: (2018)

Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14–15 September 2015
por: Williams, David J, et al.
Publicado: (2016)

Cannot write session to /tmp/vufind_sessions/sess_9fl43sjjtn8gbigut250bs669f