EMA public workshop on extrapolation of efficacy and safety in medicine development

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TitleEMA public workshop on extrapolation of efficacy and safety in medicine development
Date17/05/2016 - 18/05/2016
LocationEuropean Medicines Agency, London, UK
SummaryIn 2013, the European Medicines Agency (EMA) published a concept paper on extrapolation of efficacy and safety in medicine development. It aims to discuss the need and possibility of developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework will set out a structured approach for each extrapolation exercise, in order to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. This workshop will present the reflection paper and seek feedback from developers.

All documents

Name Language First published Last updated
EMA public workshop on extrapolation of efficacy and safety in medicine development - Outcome of a multi-stakeholder meeting with experts and regulators (English only) 18/10/2016  
Agenda - Workshop on extrapolation of efficacy and safety in medicine development across age groups (English only) 14/01/2016 13/05/2016
Registration request for the workshop on extrapolation of efficacy and safety in medicine development across age groups (English only) 14/01/2016 01/03/2016
Presentation - Quantitative challenges of extrapolation (English only) 18/10/2016  
Presentation - EMA extrapolation framework (Christoph Male) (English only) 31/05/2016  
Presentation - When do clinicians usually extrapolate in their practice? (Daniel Brasseur, Christoph Male) (English only) 31/05/2016  
Presentation - Paediatric medicines development - The need for different approaches (Sam Maldonado) (English only) 31/05/2016  
Presentation - Extrapolation: which is the patient perspective? (Marco Greco) (English only) 31/05/2016  
Presentation - A modelling and simulation perspective on extrapolation (Ine Skottheim Rusten) (English only) 31/05/2016  
Presentation - (One) Statistician(’)s perspectives on extrapolation (Rob Hemmings) (English only) 31/05/2016  
Presentation - Methodology for extrapolation in the EU FP7 ASTERIX, IDeAl and InSPiRe projects (Nigel Stallard, Ralf-Dieter Hilgers, Kit Roes) (English only) 31/05/2016  
Presentation - POS (Partial onset seizures) Extrapolation from adults to children Clinical setting (Catherine Chiron, Gerard Pons) (English only) 31/05/2016  
Presentation - Case study Brivact UCB (English only) 31/05/2016  
Presentation - Bayesian prior elicitation: an application to the MYPAN trial in childhood polyarteritis nodosa (Lisa Hampson, John Whitehead, Despina Eleftheriou, Paul Brogan) (English only) 31/05/2016  
Presentation - Model Informed Drug Discovery and Development (MID3) Good Practice: use of prior knowledge and setting up assumptions (Scott Marshall, Lutz Harnisch) (English only) 31/05/2016  
Presentation - Extrapolation of dosing, efficacy and safety of biologics in JIA, IBD and psoriasis - EMA history (Richard Veselý) (English only) 31/05/2016  
Presentation - Extrapolation & Pediatric Development: A case study from pediatric Ulcerative Colitis (Richard Strauss) (English only) 31/05/2016  
Presentation - Extrapolation in paediatric juvenile idiopathic arthritis: case study (Ruth Oliver, Laura Shaughnessy, Philippa Charlton) (English only) 31/05/2016  
Presentation - Design of PK/PD Studies (Mats Karlsson) (English only) 31/05/2016  
Presentation - Session 3: Extrapolation plan and PK/PD studies Panel Discussion (Martin Posch) (English only) 31/05/2016  
Presentation - Supporting a Pediatric Investigational Plan for Everolimus - Defining the extrapolation plan (Thomas Dumortier, Mick Looby) (English only) 31/05/2016  
Presentation - On the road to clinical extrapolation (Kristina Weber, Armin Koch) (English only) 31/05/2016  
Presentation - Paediatric Pulmonary arterial hypertension - Regulatory Perspective (Amany El-gazayerly) (English only) 31/05/2016  
Presentation - Extrapolation challenges in pediatric PAH - Possible solutions for a feasible, global study (M. Bacchi, A. Morganti, P. Cornelisse, J. Bolognese, C. Lesage, A. Kümmel, P. Nilsson) (English only) 31/05/2016  
Presentation - Extrapolation plan and statistical tools - Panel discussion (Flora Musuamba, Alexander Staab) (English only) 31/05/2016  
Presentation - Validating the extrapolation concept – methodological considerations (Andrew Thomson) (English only) 31/05/2016  
Presentation - Confirmation of extrapolation based on PK/PD data and modeling (Jacob Brogren) (English only) 31/05/2016  
Presentation - General framework on managing uncertainties (Kevin Blake) (English only) 31/05/2016  
Presentation - Decision making, revisited (English only) 31/05/2016  
Presentation - Regulatory interactions: Expectations on extrapolation approaches (Lynne Yao) (English only) 31/05/2016  
Presentation - Considerations for Implementing the EMA Extrapolation Approach: A Global Drug Developer’s Perspective (Christina Bucci-Rechtweg) (English only) 31/05/2016  
Presentation - EMA Extrapolation Framework Regulatory tools (Paolo Tomasi) (English only) 31/05/2016  

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