Fostering paediatric research and the right to extend supplementary protection certificates (original) (raw)

Committee for Medicinal Products for Human Use (CHMP) 3 Paediatric Committee (PDCO) 4 Guideline on pharmaceutical development of medicines 5 for paediatric use

Keith Benson

View PDFchevron_right

The european paediatric legislation: benefits and perspectives

Paolo Paolucci, Francesca Rocchi

2010

View PDFchevron_right

Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective

Philippe Auby

Child and Adolescent Psychiatry and Mental Health, 2008

View PDFchevron_right

Moving toward a paradigm shift in the regulatory requirements for pediatric medicines

William Chin

View PDFchevron_right

Paediatric drug development: the impact of evolving regulations

Steven Hirschfeld

Advanced Drug Delivery Reviews, 2014

View PDFchevron_right

Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years

Miriam Ceci

European Journal of Clinical Pharmacology, 2006

View PDFchevron_right

The development of medicines for children

Paolo Tomasi

Pharmacological Research, 2011

View PDFchevron_right

Making medicines that children can take

Anthony Nunn

Archives of Disease in Childhood, 2003

View PDFchevron_right

Framework conditions facilitating paediatric clinical research

Irja Lutsar

Italian Journal of Pediatrics, 2011

View PDFchevron_right

Development of Paediatric Medicines: Concepts and Principles

Klaus Rose

Pediatric Clinical Pharmacology, 2011

View PDFchevron_right

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials

Karen Trew

European Journal of Clinical Pharmacology, 2011

View PDFchevron_right

Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology

Pieter De Cock

European Journal of Pediatrics, 2020

View PDFchevron_right

The European Union Pediatric legislation: impact on pharmaceutical research in pediatric populations

Philippe Auby

Clinical investigation, 2014

View PDFchevron_right

Public awareness and views on unlicensed use of medicines in children

Tareq Mukattash

British journal of …, 2008

View PDFchevron_right

Effect of the Pediatric Exclusivity Provision on children's access to medicines

June Tordoff

British Journal of Clinical Pharmacology, 2005

View PDFchevron_right

Time for a regulatory framework for pediatric medications in Canada

Michael Rieder

Canadian Medical Association Journal

View PDFchevron_right

Recommendations by the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Working Group on preparedness of clinical trials about paediatric medicines process

Dimitris Athanasiou

Archives of Disease in Childhood, 2021

View PDFchevron_right

Paediatric clinical pharmacology in the UK

Imti Choonara

Archives of Disease in Childhood, 2014

View PDFchevron_right

Written consent to use the drug in children: the problem of off-label drugs

Diego Perez de Arenaza

Current …, 2008

View PDFchevron_right

Federal Legislation and the Advancement of Neonatal Drug Studies

Alexander Vinks

The Journal of Pediatrics, 2013

View PDFchevron_right

Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines

Roberto De Lisa

Pediatric Drugs, 2019

View PDFchevron_right

Clinical trials in pediatrics-review of ethics and law

Narayana Krishnappa

International Journal of Basic & Clinical Pharmacology

View PDFchevron_right

The medicines for children agenda in the UK

Terence Stephenson

British Journal of Clinical Pharmacology, 2006

View PDFchevron_right

The EU paediatric regulation

Luuk Kalverdijk

European Neuropsychopharmacology, 2011

View PDFchevron_right

The Pharmaceutical Benefits Scheme and implications for paediatric prescribing

Jo-Anne Brien

Journal of Paediatrics and Child Health, 2009

View PDFchevron_right

Essential drugs for infants and children : European perspective

Imti Choonara

Pediatrics, 1999

View PDFchevron_right

Assessing the Effects of Federal Pediatric Drug Safety Policies

Avi Dor

2007

View PDFchevron_right

Paediatric Pharmacotherapy and Drug Regulation -- Moving Past the Therapeutic Orphan

Michael Rieder

2020

View PDFchevron_right

European Paediatric Formulation Initiative (EuPFI)—Formulating Ideas for Better Medicines for Children

Smita Salunke

AAPS PharmSciTech, 2016

View PDFchevron_right

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

Paolo Tomasi

Therapeutic Innovation & Regulatory Science, 2017

View PDFchevron_right