ACT EU PA08 multi-stakeholder methodology workshop
EventHuman
Date
- Thursday, 23 November 2023, 09:00 (CET) - 17:00 (CET)
Location
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
Accelerating Clinical Trials in the EU (ACT EU) Priority Action 8 aims to facilitate the development of aligned clinical trial guidance across the European Medicines Regulatory Network (EMRN), resulting in high impact guidance documents implemented in practice.
This multi-stakeholder workshop on 23 November 2023 will offer participants the opportunity to:
• Understand different stakeholder perspectives on the development of clinical trial methodology guidance;
• Discuss the status of guidance on priority clinical trial methodology topics;
• Identify the need for new guidance or updates to the existing guidance for the priority methodology topics.
The output of the workshop will be brief scoping summaries for each methodology topic on the status and need for further guidance work, which will inform the future work of ACT EU Priority Action 8 and the EMRN.
No certificates of attendance will be issued for this workshop.
Live broadcast: 1C
- all plenary sessions (i.e. opening, reports from the breakout sessions, closing)
- 10:00-12:00 Break-out session A: Complex trials I
- 14:15-16:15 Break-out session E: Beyond RCTs
Live broadcast: 0B
- 10:00-12:00 Break-out session B: Paediatric Trials
- 14:15-16:15 Break-out session F: Patient-centricity