Aims of the workshop

• Build a global multidisciplinary network for digital endpoint innovation.
• Validate regulatory pathways for decentralised trials.
• Design equitable frameworks for implementation across all countries/income settings.
• Launch an ATS/ERS taskforce to set global standards for digital endpoints in respiratory disease.

Format & methods

• Expert talks: Discussion into regulatory compliance and the landmark BATURA trial (first decentralised asthma study).
• Regulatory insights: Insights into current regulatory approaches for digital endpoints and decentralised trials.
• Condition-specific discussion: Co-create digital endpoints for asthma, COPD, ILD, CF settings.

Recordings will be made available to registered participants within two weeks after the event.

Topics

• Regulatory pathways: FDA/EMA compliance, validation templates
• Trial design: BATURA case study, cost-reduction tactics
• Equity in practice: LMIC recruitment, paediatric/old adult-focused adaptations
• AI integration: Algorithm validation, real-world data pipelines
• Patient perspectives: ELF-led discussions on tech experiences

Outcomes

After attending, participants will be able to:

1. Apply an FDA/EMA-aligned framework to validate digital endpoints in your trials

2. Design recruitment strategies that boost rural/LMIC participation

3. Implement 3+ cost-reduction tactics (e.g., remote monitoring tools)

4. Navigate regulatory landscape for AI-driven respiratory endpoints

5. Input into the ATS/ERS taskforce shaping global decentralised trial standards

CME credits

This event has been accredited with 7 CME credits by the European Board for Accreditation in Pneumology (EBAP).

The number of credits that you will receive will correspond to the time you spend viewing the sessions live. Please note that you need to join the live stream with the name that corresponds to your myERS profile to ensure that you receive the CME credits.

Participants will not accrue credits for watching video recordings made available after the event has taken place.