Pulmonary Arterial Hypertension is a disorder of the blood vessels leading to the lungs, in which the blood pressure in the pulmonary artery becomes high. PAH is a serious, debilitating disease that affects both children and adults but the condition is rare in children and the signs and symptoms often differ from those seen in adults.
The European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and Health Canada are co-organising a workshop to discuss the requirements for the development of medicines for pulmonary arterial hypertension (PAH) that address the high unmet medical needs of children.
The workshop will bring together leading experts and stakeholders in PAH across the globe:
- REGULATORS
- RESEARCHERS
- CLINICIANS
- HEALTHCARE PROFESSIONALS
- PATIENTS
- PHARMACEUTICAL INDUSTRY REPRESENTATIVES
The objectives of the event are to:
- Analyse the problems related to the conduct of clinical trials in children with PAH,
- Refine endpoints and study design to address the challenges identified,
- Set priorities for future research in specific medicine development aspects,
- Provide medicine developers with more guidance specific to global product development, taking into account current limitations
For further information about this Workshop. please click at the links below:
EMA/FDA/Health Canada WORKSHOP INFO
WORKSHOP PROGRAMME
