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

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