EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension
This joint workshop organised the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and Health Canada brings together experts and stakeholders to discuss requirements for the development of medicines in paediatric pulmonary arterial hypertension (PAH) and to address the need of the current paediatric clinical practice in a timely manner. The objectives are to improve the understanding of problems related to the conduct of clinical trials in the paediatric population, refine endpoints and study design to address the clinical trials challenges in this rare paediatric population, set priorities in future research in the field of pharmacokinetics and pharmacodynamics measurements and post-marketing tools in paediatric PAH medicines and provide medicine developers with more guidance specific to global product development which takes into account current limitations.
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Programme of the EMA-FDA-Health Canada workshop on paediatric pulmonary arterial hypertension (PAH) (PDF/419.24 KB)
First published: 06/06/2017
Last updated: 20/06/2017
EMA/848554/2016 Rev.1 -
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List of participants - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension (PAH) (PDF/96.54 KB)
First published: 08/06/2017
Last updated: 20/06/2017
EMA/356444/2017 Rev.1 -
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Presentation - Paediatric Pulmonary Arterial Hypertension: Regulators perspective on a global challenge (Cà©cile Ollivier, EMA) (PDF/448.38 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Multiregional Regulatory Considerations in Pediatric Drug Development (L.Yao, U.S. FDA) (PDF/784.71 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - PHA Europe: PH kids (PDF/6.41 MB)
First published: 26/06/2017
Last updated: 26/06/2017 -
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Presentation - In focus – The paediatric PAH population clinicians perspectives (M.Beghetti) (PDF/376.25 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension (PDF/271.79 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Comparison between adult and pediatric populations with I/HPAH and PAH-CHD in the Bologna ARCA registry (N. Galià¨) (PDF/2.03 MB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Paediatric pulmonary arterial hypertension current treatment, needs and challenges (Rolf M.F. Berger, University Medical Center Groningen) (PDF/2.4 MB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Basis for regulatory decision-making: Objectives of paediatric development (A.El-Gazayerly, Dutch Medicines Evaluation Board) (PDF/183.46 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints (Health Canada) (PDF/475.02 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Hemodynamic Endpoints (C.Garnett, FDA) (PDF/631.43 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints – Patients perspective (P. Hassel) (PDF/273.85 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Use of quantitative tools for study planning purposes and study design optimisation (V. Gigante, AIFA) (PDF/439.53 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Methodological considerations (A. Thomson, EMA) (PDF/74.42 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Industry perspective on partnering with academia and agencies in drug development for children with PAH (J. Strait, Merck Sharp & Dohme) (PDF/850.46 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - Patient’s/parent’s view on clinical trial challenges (Deutsche Herzstiftung) (PDF/101.34 KB)
First published: 20/06/2017
Last updated: 20/06/2017 -
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Presentation - EnprEMA network perspectives (M. Turner, EMA) (PDF/196.8 KB)
First published: 20/06/2017
Last updated: 20/06/2017