European Medicines Agency workshop on extrapolation across age groups

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TitleEuropean Medicines Agency workshop on extrapolation across age groups
Date30/09/2015 - 30/09/2015
LocationEuropean Medicines Agency, London, UK
SummaryThe primary rationale for extrapolation is to avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are most needed. In situations where the feasibility of studies is restricted, extrapolation principles may be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources. As per the published European Medicines Agency (EMA) concept paper on extrapolation of efficacy and safety in medicine development, EMA is developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. With the aim of developing the regulatory framework the Agency is holding an EMA experts workshop on 30 September. This workshop aims to bring together experts from the European medicines regulatory network. Registration by invitation only.

All documents

Name Language First published Last updated
Agenda - Medicines Agency workshop on extrapolation across age groups (English only) 2015-07-14 2015-12-09
Presentation - Extrapolation framework: status quo and issues to be resolved (C. Male) (English only) 2015-12-09  
Presentation - When do clinicians usually extrapolate in their practice? (D. Brasseur) (English only) 2015-12-09  
Presentation - Extrapolation for antiepileptic drugs (AED) in paediatrics (G. Pons, C. Chiron) (English only) 2015-12-09  
Presentation - Modellers perspectives: how modelling and simulation can address gaps in knowledge (I. Skottheim Rusten) (English only) 2015-12-09  
Presentation - Statisticians perspectives on extrapolation (D. Wright) (English only) 2015-12-09  
Presentation - What should be the source data when considering a paediatric development (S. Cole) (English only) 2015-12-09  
Presentation - Paediatric extrapolation in FDA submissions: sources of data (G. Burckart) (English only) 2015-12-09  
Presentation - How to weigh the strength of prior information and clarify the expected level of evidence? (M. Posch) (English only) 2015-12-09  
Presentation - Dealing with risk and uncertainties (A. Nordmark, N. Benda) (English only) 2015-12-09  
Presentation - Extrapolation in antibacterial agents (I. Lutsar, M. Fernandez Cortizo) (English only) 2015-12-09  
Presentation - The role of modelling/simulation in paediatric population (J. Karres, N. Benda, J. Standing) (English only) 2015-12-09  

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