EMA public workshop on extrapolation of efficacy and safety in medicine development
In 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.
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EMA public workshop on extrapolation of efficacy and safety in medicine development - Outcome of a multi-stakeholder meeting with experts and regulators (PDF/135.45 KB)
First published: 18/10/2016
Last updated: 18/10/2016
EMA/478467/2016 -
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Agenda - Workshop on extrapolation of efficacy and safety in medicine development across age groups (PDF/117.38 KB)
First published: 14/01/2016
Last updated: 13/05/2016
EMA/12429/2016 -
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Registration request for the workshop on extrapolation of efficacy and safety in medicine development across age groups (PDF/334.23 KB)
First published: 14/01/2016
Last updated: 01/03/2016 -
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Presentation - Quantitative challenges of extrapolation (PDF/397.13 KB)
First published: 18/10/2016
Last updated: 18/10/2016 -
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Presentation - EMA extrapolation framework (Christoph Male) (PDF/561.16 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - When do clinicians usually extrapolate in their practice? (Daniel Brasseur, Christoph Male) (PDF/583.72 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Paediatric medicines development - The need for different approaches (Sam Maldonado) (PDF/3.5 MB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation: which is the patient perspective? (Marco Greco) (PDF/336.61 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - A modelling and simulation perspective on extrapolation (Ine Skottheim Rusten) (PDF/5.05 MB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - (One) Statistician(’)s perspectives on extrapolation (Rob Hemmings) (PDF/251.15 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Methodology for extrapolation in the EU FP7 ASTERIX, IDeAl and InSPiRe projects (Nigel Stallard, Ralf-Dieter Hilgers, Kit Roes) (PDF/315.62 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - POS (Partial onset seizures) Extrapolation from adults to children Clinical setting (Catherine Chiron, Gerard Pons) (PDF/355.82 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Case study Brivact UCB (PDF/999.52 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Bayesian prior elicitation: an application to the MYPAN trial in childhood polyarteritis nodosa (Lisa Hampson, John Whitehead, Despina Eleftheriou, Paul Brogan) (PDF/787.5 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Model Informed Drug Discovery and Development (MID3) Good Practice: use of prior knowledge and setting up assumptions (Scott Marshall, Lutz Harnisch) (PDF/1.09 MB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation of dosing, efficacy and safety of biologics in JIA, IBD and psoriasis - EMA history (Richard Veselà½) (PDF/553.85 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation & Pediatric Development: A case study from pediatric Ulcerative Colitis (Richard Strauss) (PDF/1.05 MB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation in paediatric juvenile idiopathic arthritis: case study (Ruth Oliver, Laura Shaughnessy, Philippa Charlton) (PDF/520.13 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Design of PK/PD Studies (Mats Karlsson) (PDF/395.01 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Session 3: Extrapolation plan and PK/PD studies Panel Discussion (Martin Posch) (PDF/51.69 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Supporting a Pediatric Investigational Plan for Everolimus - Defining the extrapolation plan (Thomas Dumortier, Mick Looby) (PDF/509.42 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - On the road to clinical extrapolation (Kristina Weber, Armin Koch) (PDF/526.53 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Paediatric Pulmonary arterial hypertension - Regulatory Perspective (Amany El-gazayerly) (PDF/217.47 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation challenges in pediatric PAH - Possible solutions for a feasible, global study (M. Bacchi, A. Morganti, P. Cornelisse, J. Bolognese, C. Lesage, A. Kà¼mmel, P. Nilsson) (PDF/277.89 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Extrapolation plan and statistical tools - Panel discussion (Flora Musuamba, Alexander Staab) (PDF/162.67 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Validating the extrapolation concept – methodological considerations (Andrew Thomson) (PDF/110.12 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Confirmation of extrapolation based on PK/PD data and modeling (Jacob Brogren) (PDF/663.63 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - General framework on managing uncertainties (Kevin Blake) (PDF/156.85 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Decision making, revisited (PDF/344.21 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Regulatory interactions: Expectations on extrapolation approaches (Lynne Yao) (PDF/3.36 MB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - Considerations for Implementing the EMA Extrapolation Approach: A Global Drug Developer’s Perspective (Christina Bucci-Rechtweg) (PDF/833.34 KB)
First published: 31/05/2016
Last updated: 31/05/2016 -
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Presentation - EMA Extrapolation Framework Regulatory tools (Paolo Tomasi) (PDF/680.18 KB)
First published: 31/05/2016
Last updated: 31/05/2016