EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension

  • Email
  • Help

Details

TitleEMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension
Date12/06/2017 - 13/06/2017
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

Name Language First published Last updated
Programme of the EMA-FDA-Health Canada workshop on paediatric pulmonary arterial hypertension (PAH) (English only) 2017-06-06 2017-06-20
List of participants - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension (PAH) (English only) 2017-06-08 2017-06-20
Presentation - Paediatric Pulmonary Arterial Hypertension: Regulators perspective on a global challenge (Cécile Ollivier, EMA) (English only) 2017-06-20  
Presentation - Multiregional Regulatory Considerations in Pediatric Drug Development (L.Yao, U.S. FDA) (English only) 2017-06-20  
Presentation - PHA Europe: PH kids (English only) 2017-06-26  
Presentation - In focus – The paediatric PAH population clinicians perspectives (M.Beghetti) (English only) 2017-06-20  
Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension (English only) 2017-06-20  
Presentation - Comparison between adult and pediatric populations with I/HPAH and PAH-CHD in the Bologna ARCA registry (N. Galiè) (English only) 2017-06-20  
Presentation - Paediatric pulmonary arterial hypertension current treatment, needs and challenges (Rolf M.F. Berger, University Medical Center Groningen) (English only) 2017-06-20  
Presentation - Basis for regulatory decision-making: Objectives of paediatric development (A.El-Gazayerly, Dutch Medicines Evaluation Board) (English only) 2017-06-20  
Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints (Health Canada) (English only) 2017-06-20  
Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Hemodynamic Endpoints (C.Garnett, FDA) (English only) 2017-06-20  
Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints – Patients perspective (P. Hassel) (English only) 2017-06-20  
Presentation - Use of quantitative tools for study planning purposes and study design optimisation (V. Gigante, AIFA) (English only) 2017-06-20  
Presentation - Methodological considerations (A. Thomson, EMA) (English only) 2017-06-20  
Presentation - Industry perspective on partnering with academia and agencies in drug development for children with PAH (J. Strait, Merck Sharp & Dohme) (English only) 2017-06-20  
Presentation - Patient’s/parent’s view on clinical trial challenges (Deutsche Herzstiftung) (English only) 2017-06-20  
Presentation - EnprEMA network perspectives (M. Turner, EMA) (English only) 2017-06-20  

Media Videos


Video recording

A video recording is now available.

To view use the 'Multimedia' tab.

Related content