Workshop on Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children
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1 Workshop on Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children Dr Oscar Della Pasqua WP 4 11th June 2013 Strathclyde University, Glasgow, UK
2 Project AIMS General Aim To implement an framework to facilitate the development and safe use of medicine in children through the development of a comprehensive training program and integrated use of existing research capacity Specific Objectives To create consensus on standards, d methodologies and tools for paediatric i research, primarily focus on: the contents of a Paediatric Clinical Pharmacology Training Program harmonisation of research tools specific for paediatrics sharing of experience and expertise
3 WORKPACKAGES WP1 aims at establishing an internationally recognised educationalprograminpaediatric in paediatric clinical pharmacology It aims at creating a learning environment in which paediatricians, medical sub specialists, clinical pharmacists, health care professionals, regulatory authorities, members of the pharmaceutical industry and other relevant organisations can gain expertise in all aspects of paediatric clinical pharmacology and paediatric drug development Achievements: Inventory of existing training programs and courses for inclusion in Training Program Palette Detailed core curriculum with specialisation in paediatric clinical pharmacology: GRiP Paediatric Clinical Pharmacology Fellowship curriculum Web based learning environment
4 WORKPACKAGES WP2 aims at boosting pediatric pharmacoepidemiology and creating a platform that allow for rapid, large scale studies providing integrated evidence on the use and effects of drugs and vaccines in children. Achievements: Online platform ltf for real time dt data sharing and scientific collaboration Identification of healthcare databases with population based information on drug use and vaccine outcomes in children Map of disease and drug/vaccine coding terminologies across databases
5 WORKPACKAGES WP5 is aimed at the creation of a International Paediatric Formulation Knowledge Platform to share knowledge, expertise and experience around paediatric drug delivery as well as pharmaceutical issues in clinical trials and in clinical practice worldwide. Achievements: Launch of paediatric formulation webpage on the GRiP website bi Inventory of experts on paediatric formulations User guide and web forum
6 WORKPACKAGES WP6 is aimed at addressing issues related to the conduction of clinical drug trials in neonates. Main action: create aninventory ofprotocols and available pharmaceutical technologies for drug delivery in neonatal diseases. Achievements: Inventory of existing neonatal networks outside EU and creation of an international ti registry it Mapping of agreed definitions for risk factors, complications and short and long term outcomes in neonates
7 WP4 Paediatric Clinical Studies Implementation of alternative inferential methods for demonstrating efficacy and safety in paediatric population, with focus on the identification of the minimal level of evidence required for establishing risk/benefit ratio of a paediatric medicinal product Exploit itthe potential ti advantages of modelling & simulation and extrapolation concepts in conjunction with innovative statistical designs with the ultimategoal of reducing the number of children enrolled in clinical trials and identifying the prerequisites for suitable comparators
8 Areas in which unmet medical needs have been clear demonstrated reas on utic Ar stigatio erapeu f Inves The of Areas in which medicinal products are not optimally used in the paediatric population Paradigm diseases: pain and epilepsy
9 WP4 STRUCTURE AND INTERACTIONWITH OTHER WPs Modelling & Simulation Sample size Data extrapolation O. Della Pasqua H. van der Lee G. Pons WP1 clinical pharmacology international training program Managing Group (10 partner representatives) Expert Group WP3 Research tools to facilitate interoperability Innovative design P. Baiardi Comparators M. Offringa WP6 Neonatology
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