EMA multi-stakeholder workshop on Acute Respiratory Distress Syndrome
EventHuman
Date
- Tuesday, 21 November 2023, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
EMA is organising an online multi-stakeholder workshop on Acute Respiratory Distress Syndrome (ARDS) to provide a platform for discussion on key aspects for development of new medicinal products in ARDS.
EMA is currently reviewing the guideline for ARDS in order to bring together current scientific knowledge in ARDS and recent experience gained in the management of COVID-19 patients experiencing Acute Respiratory Distress Syndrome. To this aim a concept paper has been adopted by CHMP in April 2023 and is currently under public consultation until 31 July 2023.
EMA promotes regulatory science and innovation by providing state of the art recommendations to drug developers. The guideline will support evidence generation and enable appropriate methodology for the evaluation of new medicinal products for prevention and treatment of ARDS and to further inform regulatory decision making.
This EMA multi-stakeholder workshop will bring together academia, learned societies, patients, HTA bodies, medicines regulators and industry to explore clinical and scientific aspects related to the development of drugs for patients with Acute Respiratory Disease Syndrome, to share and discuss evolution of clinical knowledge and science in medicines’ development for ARDS patients while ensuring efficient and robust assessment. The discussion will ultimately inform the finalisation of the guideline on Acute Respiratory Distress Syndrome.
The aims of the workshop are to discuss:
- ARDS syndrome, and biomarkers;
- study population and Standard of Care;
- primary and secondary endpoints;
- clinical trial methodology and design.
Individuals, specialists in this area can contribute their expertise.